In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
ADC Production - A Journey made safer and fasterMilliporeSigma
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
Commercializing antibody-drug conjugates: a CMO’s journeyMerck Life Sciences
Watch the webinar here: https://bit.ly/2YLDzTE
This webinar will take you through the story of a CMO preparing for the manufacture of a Commercial Antibody Drug Conjugate (ADC).
Join us to learn about how we grew as a CMO to develop a Commercial ADC program. We will walk through the full timeline from development, process risk assessment and control strategy development and validation, finishing off with preparation for a Commercial ADC Pre-Approval Inspection Audit.
In this webinar you will learn how to:
• Properly structure your development work
• Perform a thorough process risk assessment
• Prepare for pre-approval inspection
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
The Butterfly Effect: How to see the impact of small changes to your ADCMilliporeSigma
This document summarizes key aspects of characterizing antibody drug conjugates (ADCs), including:
1) A case study examining how different polyethylene glycol (PEG) linker sizes affect ADC structure and target binding. Peptide mapping by mass spectrometry showed conjugation sites varied with linker size. Hydrogen/deuterium exchange mass spectrometry showed conjugation induced conformational changes.
2) Methods for assessing ADC mechanisms of action, including measuring internalization, cytotoxicity, and effector functions.
3) An overview of MilliporeSigma's comprehensive ADC product characterization and biosafety testing services across multiple sites.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...Merck Life Sciences
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
ADC Production - A Journey made safer and fasterMilliporeSigma
In this webinar, you will learn:
How Single-Use helps to simplify ADC manufacturing
Safety and Integrity of the complete process
Flexibility and adaptability to changing needs
How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC
Detailed description:
The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
Commercializing antibody-drug conjugates: a CMO’s journeyMerck Life Sciences
Watch the webinar here: https://bit.ly/2YLDzTE
This webinar will take you through the story of a CMO preparing for the manufacture of a Commercial Antibody Drug Conjugate (ADC).
Join us to learn about how we grew as a CMO to develop a Commercial ADC program. We will walk through the full timeline from development, process risk assessment and control strategy development and validation, finishing off with preparation for a Commercial ADC Pre-Approval Inspection Audit.
In this webinar you will learn how to:
• Properly structure your development work
• Perform a thorough process risk assessment
• Prepare for pre-approval inspection
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
The Butterfly Effect: How to see the impact of small changes to your ADCMilliporeSigma
This document summarizes key aspects of characterizing antibody drug conjugates (ADCs), including:
1) A case study examining how different polyethylene glycol (PEG) linker sizes affect ADC structure and target binding. Peptide mapping by mass spectrometry showed conjugation sites varied with linker size. Hydrogen/deuterium exchange mass spectrometry showed conjugation induced conformational changes.
2) Methods for assessing ADC mechanisms of action, including measuring internalization, cytotoxicity, and effector functions.
3) An overview of MilliporeSigma's comprehensive ADC product characterization and biosafety testing services across multiple sites.
Payload Core Product Line Accelerates ADC Clinical TimelinesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3ddy1sT
Innovators currently must endure years of development and manufacturing to arrive at the most commonly used cGMP payloads. Explore our core product line for dolastatin and maytansinoid payloads which can get developers to the clinic faster while reducing risk.
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.
DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.
In this webinar, you will learn about:
• Advantages of dolastatin over other payloads in ADC therapies
• Proprietary DOLCore™ and MayCore™ products
• Flexibility to make new or established dolastatins
• Rapid synthesis technology accelerating the path to drug commercialization
• Seamless supply chain with reduced complexity and regulatory support
Presented by: David Goeddel, Ph.D., Director of API R&D
Keeping the (Adventitious) Virus Out of the (Adeno-Associated) VirusMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/2VRylbi
How can you keep an adventitious virus from contaminating your gene therapy that is delivered by an adeno virus vector? As viral vector bioprocessing advances, regulatory requirements for viral safety will as well. Learn how to define your viral clearance strategy for AAV delivered gene therapies.
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?
Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.
Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.
In this webinar, you will learn:
• AAV process flows and focus areas for viral safety
• Strategies for implementing viral clearance measures in bioprocessing
• Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
• Best practices and evaluation roadmaps on conducting viral clearance studies
Presented by: Ratish Krishnan, Senior Strategy Consultant, Novel Modalities Bioprocessing
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...Merck Life Sciences
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
The Role of Process Characterization in Process ValidationDavid Goodrich
The document discusses the role of process characterization in process validation. It begins by defining process validation and process characterization. Process characterization aims to identify and quantify all significant sources of variation, especially inherent variation in materials and technology as applied to the specific product design. Characterization studies determine how the process performs under worst-case conditions prior to qualification testing. The document then provides two case studies as examples of using design of experiments to characterize processes and identify optimal process settings.
Membrane Chromatography Solutions for Single-Use, Intensified mAb PurificationMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/NatrixChromMRK
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Explore our webinar library: www.merckmillipore.com/webinars
Setting up for successful lot release testing by Edmund AngMerck Life Sciences
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Setting up for successful lot release testing by Edmund AngMilliporeSigma
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Introduction to Tangential Flow Filtration (TFF)MilliporeSigma
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
From preclinical to commercial: The evolution of ADC manufacturing expertise ...MilliporeSigma
ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to both conjugation, linker and toxin chemistries as well as processing. With the current availability of four commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain to make manufacturing efficient. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.
MilliporeSigma has been involved with the development and manufacturing of ADCs since 2008. This webinar will discuss how chemistry and manufacturing have evolved over the past 10 years globally and how MilliporeSigma, as a CDMO has adapted to these changes to meet customers needs.
In this webinar, you will learn:
● How ADC manufacturing has evolved over the past decade
● The challenges that this evolution implies
● Why an integrated supply chain has become increasingly important for the success of ADC projects
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...Merck Life Sciences
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Membrane Chromatography Solutions for Single-Use, Intensified mAb PurificationMilliporeSigma
Participate in the interactive webinar: http://bit.ly/NatrixChromMSIG
Explore our webinar library: www.emdmillipore.com/webinars
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
An Efficient and cGMP-friendly Solution to Diafiltration for Intensified or C...Merck Life Sciences
This document presents a new continuous diafiltration (CDF) system as an efficient solution for intensified or continuous bioprocessing. The CDF system uses tank cycling to keep the membrane in use for diafiltration for most of the time. A 24-hour demonstration of the CDF system showed stable and consistent performance over 24 cycles with less than 6% variation in key parameters like cycle time, flux, conductivity, yield and product concentration. The CDF solution provides 6-8 fold higher membrane utilization compared to batch diafiltration with comparable buffer usage but significantly reduced footprint and linear scalability. It is a robust solution for continuous processing that does not require process re-development.
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
The cell and gene therapy market is growing rapidly and is projected to reach $10 billion in 5 years. There are three main segments: gene therapy, stem cell therapy, and cell immunotherapy. Gene therapy uses viral vectors like lentivirus or adenovirus to deliver nucleic acids. The production of viral vectors like AAV involves growing HEK 293 cells in bioreactors, transfecting them with plasmids, harvesting and purifying the virus through clarification, filtration, and chromatography. CAR-T cell therapy is also discussed as an example of cell immunotherapy, which uses lentivirus to modify patient T-cells that are then reintroduced to the patient.
Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...MilliporeSigma
This document discusses an integrated approach to ensuring viral vector and gene therapy commercial readiness. It covers four main topics: 1) the current state and future perspectives of viral vectors, 2) scalability and reproducibility in viral vector manufacturing, 3) testing and quality considerations, and 4) regulatory approval and commercial readiness. The current demand for clinical and commercial doses of viral vectors is increasing. Ensuring scalable, reproducible manufacturing processes and comprehensive testing and quality measures is critical for regulatory approval and commercialization.
The webinar discusses services from MilliporeSigma to accelerate antibody-drug conjugate (ADC) development through their ADC Express and ADCore product lines. ADC Express provides integrated antibody, linker, payload, and conjugation services to generate multiple ADC candidates for evaluation. The ADCore product line offers intermediates that simplify payload synthesis and accelerate development timelines. ChetoSensar technology incorporates a chito-oligosaccharide to enhance ADC solubility and efficacy.
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...MilliporeSigma
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...Merck Life Sciences
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
High-throughput and Automated Process Development for Accelerated Biotherapeu...KBI Biopharma
KBI Biopharma has developed high-throughput and automated processes to accelerate biotherapeutic development. This includes establishing a high-throughput process development team utilizing automated equipment and informatics solutions. Analytical case studies demonstrate automation of a residual host cell protein ELISA using a liquid handling robot, reducing analysis time from hours to minutes per sample. A second case study outlines development of a high-throughput size exclusion chromatography method, reducing run time from 30 minutes to 6 minutes while still effectively screening for high molecular weight species. These efforts allow for real-time data generation and monitoring of process development experiments.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...Merck Life Sciences
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMilliporeSigma
Participate in the interactive webinar; http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.emdmillipore.com/webinars
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.merckmillipore.com/webinars
The Role of Process Characterization in Process ValidationDavid Goodrich
The document discusses the role of process characterization in process validation. It begins by defining process validation and process characterization. Process characterization aims to identify and quantify all significant sources of variation, especially inherent variation in materials and technology as applied to the specific product design. Characterization studies determine how the process performs under worst-case conditions prior to qualification testing. The document then provides two case studies as examples of using design of experiments to characterize processes and identify optimal process settings.
Membrane Chromatography Solutions for Single-Use, Intensified mAb PurificationMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/NatrixChromMRK
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Explore our webinar library: www.merckmillipore.com/webinars
Setting up for successful lot release testing by Edmund AngMerck Life Sciences
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Setting up for successful lot release testing by Edmund AngMilliporeSigma
Is your lot release testing strategy ready for global commercialization?
In this webinar, you will learn:
• CMC testing requirements with CHO production platform for global commercialization
• Lot release testing of product intermediates and final product
• Product-specific qualification study
• Alternative rapid testing methods to advance lot release testing
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.
In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.
Introduction to Tangential Flow Filtration (TFF)MilliporeSigma
This presentation provides an introduction to tangential flow filtration and reviews the following:
- TFF process basics and terminology
- TFF membrane technology
- TFF hardware, devices and systems
- Growing applications and the future
To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
From preclinical to commercial: The evolution of ADC manufacturing expertise ...MilliporeSigma
ADCs have evolved since the initial approval of MYLOTARG® in 2000, with respect to both conjugation, linker and toxin chemistries as well as processing. With the current availability of four commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain to make manufacturing efficient. With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.
MilliporeSigma has been involved with the development and manufacturing of ADCs since 2008. This webinar will discuss how chemistry and manufacturing have evolved over the past 10 years globally and how MilliporeSigma, as a CDMO has adapted to these changes to meet customers needs.
In this webinar, you will learn:
● How ADC manufacturing has evolved over the past decade
● The challenges that this evolution implies
● Why an integrated supply chain has become increasingly important for the success of ADC projects
Optimization of Tangential Flow Filtration Applications and Scale Up Consider...Merck Life Sciences
This presentation provides an introduction to tangential flow filtration applications for AAV and lentivirus and will review:
• Basics of tangential flow filtration (TFF)
• TFF AAV and lentivirus process overview
• Operating parameters optimization: flux-controlled microfiltration
• Scale up considerations
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Membrane Chromatography Solutions for Single-Use, Intensified mAb PurificationMilliporeSigma
Participate in the interactive webinar: http://bit.ly/NatrixChromMSIG
Explore our webinar library: www.emdmillipore.com/webinars
Improve productivity, flexibility, and economics of mAb purification process with intensified, single-use membrane chromatography.
Selecting the right aseptic filter for your process can be complicated: today’s biomanufacturer has many filter choices each offering distinct benefits. Understanding the specific needs for individual operations, in terms of flux, capacity, bioburden reduction or sterilizing performance, gamma or thermal compatibility and single or multi-use will inform decisions that have implications for the life of the process. This webinar will provide general customer guidance and explain the benefits and disadvantages of different options to help guide customers to the most appropriate filter for their operation.
In this webinar, you will learn:
- How filter design impacts performance
- Important criteria for filter selection
- New choices and options to maximize productivity for biomanufacturers
An Efficient and cGMP-friendly Solution to Diafiltration for Intensified or C...Merck Life Sciences
This document presents a new continuous diafiltration (CDF) system as an efficient solution for intensified or continuous bioprocessing. The CDF system uses tank cycling to keep the membrane in use for diafiltration for most of the time. A 24-hour demonstration of the CDF system showed stable and consistent performance over 24 cycles with less than 6% variation in key parameters like cycle time, flux, conductivity, yield and product concentration. The CDF solution provides 6-8 fold higher membrane utilization compared to batch diafiltration with comparable buffer usage but significantly reduced footprint and linear scalability. It is a robust solution for continuous processing that does not require process re-development.
Process Development for Cell Therapy and Viral Gene TherapyMerck Life Sciences
Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product.
The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.
Watch the interactive webinar now: https://bit.ly/2VplwQq
Production and purification of Viral vectors for gene and cell therapy appli...Dr. Priyabrata Pattnaik
The cell and gene therapy market is growing rapidly and is projected to reach $10 billion in 5 years. There are three main segments: gene therapy, stem cell therapy, and cell immunotherapy. Gene therapy uses viral vectors like lentivirus or adenovirus to deliver nucleic acids. The production of viral vectors like AAV involves growing HEK 293 cells in bioreactors, transfecting them with plasmids, harvesting and purifying the virus through clarification, filtration, and chromatography. CAR-T cell therapy is also discussed as an example of cell immunotherapy, which uses lentivirus to modify patient T-cells that are then reintroduced to the patient.
Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...MilliporeSigma
This document discusses an integrated approach to ensuring viral vector and gene therapy commercial readiness. It covers four main topics: 1) the current state and future perspectives of viral vectors, 2) scalability and reproducibility in viral vector manufacturing, 3) testing and quality considerations, and 4) regulatory approval and commercial readiness. The current demand for clinical and commercial doses of viral vectors is increasing. Ensuring scalable, reproducible manufacturing processes and comprehensive testing and quality measures is critical for regulatory approval and commercialization.
The webinar discusses services from MilliporeSigma to accelerate antibody-drug conjugate (ADC) development through their ADC Express and ADCore product lines. ADC Express provides integrated antibody, linker, payload, and conjugation services to generate multiple ADC candidates for evaluation. The ADCore product line offers intermediates that simplify payload synthesis and accelerate development timelines. ChetoSensar technology incorporates a chito-oligosaccharide to enhance ADC solubility and efficacy.
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...MilliporeSigma
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...Merck Life Sciences
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
High-throughput and Automated Process Development for Accelerated Biotherapeu...KBI Biopharma
KBI Biopharma has developed high-throughput and automated processes to accelerate biotherapeutic development. This includes establishing a high-throughput process development team utilizing automated equipment and informatics solutions. Analytical case studies demonstrate automation of a residual host cell protein ELISA using a liquid handling robot, reducing analysis time from hours to minutes per sample. A second case study outlines development of a high-throughput size exclusion chromatography method, reducing run time from 30 minutes to 6 minutes while still effectively screening for high molecular weight species. These efforts allow for real-time data generation and monitoring of process development experiments.
EU GMP Annex 1 Draft - Closed System Design Consideration with Single-Use Sys...Merck Life Sciences
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. Please attend the webinar to learn more!
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMilliporeSigma
Participate in the interactive webinar; http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.emdmillipore.com/webinars
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.merckmillipore.com/webinars
Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
Tackling the challenges of single-use manufacturing for ADCsMerck Life Sciences
You can watch the webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
Implementing and Managing Pre-use Post-sterilization Integrity Testing (PUPSIT)MilliporeSigma
This document summarizes a presentation given at a conference on aseptic processing. It discusses challenges implementing pre-use integrity testing (PUPSIT) of sterile filters for final product filtration and provides case studies of both successful and unsuccessful filtration setups. The presentation addresses common issues like filter sizing, complex product formulations that impact integrity testing, and assembly details. It promotes the ability to achieve PUPSIT with current single-use technology and filtration setup options.
Implementing and Managing Pre-use Post-sterilization Integrity Testing (PUPSIT)Merck Life Sciences
This presentation explores best practices and case studies in aseptic processing, including how to implement and manage PUPSIT. You will learn:
• Integrity Testing – the background on IT itself, why it is important, and how it works
• Filtration setups and single-use technology
• The PUPSIT debate and how PUPSIT can be achieved with current technology, final filling, formulation, filtration
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
Enablers to increase predictability and service in a demanding and complex commercial supply chain, presentation made to MERCK SUN Conference, September 2013
PPT _ 2022 Norway Customer Event_Introduction to CEMS .pdfbiswajitnandi96
Continuous Emission Monitoring Systems (CEMS) solutions from ABB provide market-leading performance and reliability while delivering unrivaled value for money. ABB offers a comprehensive portfolio of CEMS products, services, and digital solutions to support customers throughout the entire lifecycle. With over 90 years of experience and 600 service engineers worldwide, ABB aims to exceed customer expectations by maximizing system availability, minimizing maintenance needs, and ensuring the lowest cost of ownership.
Webinar: How a Helium Manufacturing Release Test Increases Integrity Assuranc...Merck Life Sciences
The document discusses MilliporeSigma's helium integrity test technology for validating the integrity of single-use systems. It provides an overview of regulatory guidance on integrity testing, outlines MilliporeSigma's three pillar strategy for integrity assurance, and describes how the helium integrity test works and its ability to detect defects down to 2 microns in size. Mobius single-use assemblies are tested using this method and receive a certificate of quality to verify 100% integrity testing.
Webinar: How a Helium Manufacturing Release Test Increases Integrity Assuranc...MilliporeSigma
Register now to participate in the interactive, on-demand webinar: https://event.on24.com/wcc/r/3633644/850DBDCF39356D977DE6158F85BFAAC1?partnerref=SlideShare
In this webinar, you will learn:
- Different approaches for integrity testing single-use systems
- The benefits of the helium integrity test for increased integrity assurance in critical single-use systems
Detailed description:
Helium integrity testing is an industry-proven test that detects defects in single-use systems. This sensitive test reduces the risk of leaks or microbial ingress into manufacturing processes so manufacturers can be confident their entire systems, including tubing and connection points, are integral. This is especially critical during freezing, thawing, transportation and storage. This webinar will describe development and validation of the helium integrity test and demonstrate how it can benefit critical single-use process steps.
In-Spec UV Vis Standards and Good Lab PracticeLiza Tallon
The document discusses how using leading-edge calibration standards can provide marketing advantages beyond mere compliance. It describes GFS Chemicals' In-Spec and AMCO Clear uniform submicron polymer standards for instrument calibration. These standards offer benefits like validated performance, time and cost savings, and assurance that methods meet regulatory standards from agencies like NIST, EPA, FDA, ensuring credibility. The standards minimize errors from improper technique or unstable products, helping users gain technical credibility and partnering advantages in today's competitive marketplace.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...Merck Life Sciences
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
This document provides an overview and getting started guide for the Commander SK variable speed drive for 3-phase induction motors from 0.25kW to 7.5kW. It includes information on safety, ratings, installation, keypad operation, parameters, commissioning and diagnostics. The drive is designed to comply with relevant European standards for electromagnetic compatibility and low voltage directives when installed correctly.
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
Filtersafe automatic screen filters provide effective filtration down to 10 microns for ballast water treatment systems. Commissioning testing of these systems in real-world conditions can be challenging due to factors outside of the manufacturer's control, such as dirty ballast lines or poor water quality. Proper preparation, including ensuring filters are selected to handle the expected conditions, can help optimize the chances of passing commissioning testing on the first attempt. SGS offers ballast water testing services globally to verify systems meet the D-2 standard through both indicative and detailed analysis.
Sunil David Presentation on Traceability-automation expo 22.pptxMoienMuzaffarBhat
The document discusses the importance of track and trace solutions in manufacturing. It provides examples of large product recalls that resulted in significant costs for automakers. The document outlines different layers of traceability use cases and how a combination of technologies can enable end-to-end traceability. Case studies of implementation at Asian Paints and JK Tyres show benefits like quality improvement, energy optimization, productivity gains and full product traceability. The role of 5G networks in enabling smart factories with low latency applications is also covered.
This document discusses high performance thin layer chromatography (HPTLC). It describes the principles of HPTLC, which uses adsorption chromatography to separate components based on their affinity for the stationary and mobile phases. The key features, steps, and instrumentation of HPTLC are outlined. Various applications of HPTLC in fields like herbal analysis, pharmaceutical science, and forensics are mentioned. The document also discusses qualification processes like installation qualification and operation qualification that are important for cGMP regulated environments using HPTLC.
This document provides instructions for setting up and running the Unidrive M702 drive. It covers basic mechanical and electrical installation, getting started procedures like understanding the display and menu structure, and performing a quick start commissioning. Safety information is also provided, noting that the full user guide should be referred to for safety-critical applications. The guide includes specifications on the drive model and ratings as well as features, options, and accessories.
Similar to ADC Production - A Journey made safer and faster (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...Merck Life Sciences
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMerck Life Sciences
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...Merck Life Sciences
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...Merck Life Sciences
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...Merck Life Sciences
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...Merck Life Sciences
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...Merck Life Sciences
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Insights from a Global Collaboration Accelerating Vaccine Development with an...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMerck Life Sciences
The document discusses testing done to qualify the use of x-ray sterilization for a Lynx S2S connector. Physical, chemical, and biological tests were performed on connectors that underwent either x-ray or gamma sterilization. Test results showed comparable extractable levels, thermal properties, and chromatographic profiles between the two sterilization methods. This provides evidence that x-ray sterilization is a suitable alternative to gamma sterilization for this connector.
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing
Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...Merck Life Sciences
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
Regulatory Considerations for Excipients used in Lipid NanoparticlesMerck Life Sciences
Lipid excipients and delivery systems such as lipid nanoparticles (LNPs) are essential for a wide variety of therapeutics including mRNA vaccines and therapeutics and gene therapy.
The purity and safety of novel, synthetic lipid excipients must be demonstrated due to their central role in the function of the drug product, distinct physicochemical properties, and the potential for interaction with other ingredients or the physicochemical environment. These excipients must comply with challenging and complex regulatory requirements, similar to those expected of the active pharmaceutical ingredient itself.
This whitepaper provides an overview of the regulatory classification of lipid nanoparticles, liposomes and novel excipients. Specific requirements outlined in guidance documents are shared along with strategies to stay ahead of emerging regulatory challenges.
To find more information about synthetic lipids for pharmaceutical applications and gene therapy, please visit our website:
https://www.sigmaaldrich.com/DE/en/products/pharma-and-biopharma-manufacturing/formulation/synthetic-lipids
https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/formulation/synthetic-lipids
Introducing our novel Sf9 rhabdovirus-negative (Sf-RVN®) Platform.pdfMerck Life Sciences
The Baculovirus Expression Vector System (BEVS) is a powerful eucaryotic vector system and Spodoptera frugiperda (Sf) cell lines are widely used as hosts for BEVS. However, the majority of Sf9 and Sf21 cell lines contain a Sf-rhabdovirus which is considered a process contaminant and must be eliminated during the process. To improve the safety profile of the BEVS production method, we offer a Sf9 rhabdovirus-negative (Sf-RVN®) cell line with companion chemically defined medium. Combined, they form the Sf-RVN® Platform which provides a performant rhabdovirus-free BEVS alternative to produce recombinant protein, VLP and AAV and enhances risk mitigation.
The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein F...Merck Life Sciences
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
We are one of the top Massage Spa Ajman Our highly skilled, experienced, and certified massage therapists from different corners of the world are committed to serving you with a soothing and relaxing experience. Luxuriate yourself at our spas in Sharjah and Ajman, which are indeed enriched with an ambiance of relaxation and tranquility. We could confidently claim that we are one of the most affordable Spa Ajman and Sharjah as well, where you can book the massage session of your choice for just 99 AED at any time as we are open 24 hours a day, 7 days a week.
Visit : https://massagespaajman.com/
Call : 052 987 1315
Feeding plate for a newborn with Cleft Palate.pptxSatvikaPrasad
A feeding plate is a prosthetic device used for newborns with a cleft palate to assist in feeding and improve nutrition intake. From a prosthodontic perspective, this plate acts as a barrier between the oral and nasal cavities, facilitating effective sucking and swallowing by providing a more normal anatomical structure. It helps to prevent milk from entering the nasal passage, thereby reducing the risk of aspiration and enhancing the infant's ability to feed efficiently. The feeding plate also aids in the development of the oral muscles and can contribute to better growth and weight gain. Its custom fabrication and proper fitting by a prosthodontist are crucial for ensuring comfort and functionality, as well as for minimizing potential complications. Early intervention with a feeding plate can significantly improve the quality of life for both the infant and the parents.
Stem Cell Solutions: Dr. David Greene's Path to Non-Surgical Cardiac CareDr. David Greene Arizona
Explore the groundbreaking work of Dr. David Greene, a pioneer in regenerative medicine, who is revolutionizing the field of cardiology through stem cell therapy in Arizona. This ppt delves into how Dr. Greene's innovative approach is providing non-surgical, effective treatments for heart disease, using the body's own cells to repair heart damage and improve patient outcomes. Learn about the science behind stem cell therapy, its benefits over traditional cardiac surgeries, and the promising future it holds for modern medicine. Join us as we uncover how Dr. Greene's commitment to stem cell research and therapy is setting new standards in healthcare and offering new hope to cardiac patients.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Dr. David Greene R3 stem cell Breakthroughs: Stem Cell Therapy in CardiologyR3 Stem Cell
Dr. David Greene, founder and CEO of R3 Stem Cell, is at the forefront of groundbreaking research in the field of cardiology, focusing on the transformative potential of stem cell therapy. His latest work emphasizes innovative approaches to treating heart disease, aiming to repair damaged heart tissue and improve heart function through the use of advanced stem cell techniques. This research promises not only to enhance the quality of life for patients with chronic heart conditions but also to pave the way for new, more effective treatments. Dr. Greene's work is notable for its focus on safety, efficacy, and the potential to significantly reduce the need for invasive surgeries and long-term medication, positioning stem cell therapy as a key player in the future of cardiac care.
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
The South Beach Coffee Java Diet is a variation of the popular South Beach Diet, which was developed by cardiologist Dr. Arthur Agatston. The original South Beach Diet focuses on consuming lean proteins, healthy fats, and low-glycemic index carbohydrates. The South Beach Coffee Java Diet adds the element of coffee, specifically caffeine, to enhance weight loss and improve energy levels.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Under Pressure : Kenneth Kruk's StrategyKenneth Kruk
Kenneth Kruk's story of transforming challenges into opportunities by leading successful medical record transitions and bridging scientific knowledge gaps during COVID-19.
Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
Chandrima Spa Ajman is one of the leading Massage Center in Ajman, which is open 24 hours exclusively for men. Being one of the most affordable Spa in Ajman, we offer Body to Body massage, Kerala Massage, Malayali Massage, Indian Massage, Pakistani Massage Russian massage, Thai massage, Swedish massage, Hot Stone Massage, Deep Tissue Massage, and many more. Indulge in the ultimate massage experience and book your appointment today. We are confident that you will leave our Massage spa feeling refreshed, rejuvenated, and ready to take on the world.
Visit : https://massagespaajman.com/
Call : 052 987 1315
KEY Points of Leicester travel clinic In London doc.docxNX Healthcare
In order to protect visitors' safety and wellbeing, Travel Clinic Leicester offers a wide range of travel-related health treatments, including individualized counseling and vaccines. Our team of medical experts specializes in getting people ready for international travel, with a particular emphasis on vaccines and health consultations to prevent travel-related illnesses. We provide a range of travel-related services, such as health concerns unique to a trip, prevention of malaria, and travel-related medical supplies. Our clinic is dedicated to providing top-notch care, keeping abreast of the most recent recommendations for vaccinations and travel health precautions. The goal of Travel Clinic Leicester is to keep you safe and well-rested no matter what kind of travel you choose—business, pleasure, or adventure.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...
ADC Production - A Journey made safer and faster
1. Ashok Kumar N, Head – Single Use & Integrated Systems, India
Bangalore, India, 30th November 2021
A journey made safer and faster
ADC Production
Pharma & Biopharma Raw
Material Solutions
2. 2
The Life Science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.
ADC Production – A journey made safer and faster| 30.11.2021
3. Agenda
Introduction to ADC
Single Use Technology for ADC
production
Single use Components –
Compatibility and testing
Conclusion
1
2
3
5
ADC, Single Use cGMP
Production – Key
Considerations
4
3 ADC Production – A journey made safer and faster| 30.11.2021
5. ADC Production – A journey made safer and faster| 30.11.2021
5
According to the research report, global market is
projected to display a robust growth represented
by a Compound annual growth rate (CAGR) of
21.82% during 2017-2022, chiefly driven by large
number of ADC drugs in pipeline, rising number
of cancer patients and wider therapeutic window
offered by antibody drug conjugates.
Source: "Global Antibody Drug Conjugates (ADC) Market -
Analysis By Drugs (Adcetris, Kadcyla), Pipeline Drugs,
Regulations: Opportunities and Forecasts (2017-2022)",
Link:(https://www.researchandmarkets.com/research/q6jlz9/glob
al_antibody)
Market Dynamics - The Future of ADCs
6. ADC Production – A journey made safer and faster| 30.11.2021
6
What is ADC?
ADC: The Guided-missile Cancer
Treatment
ADC = Antibody Drug Conjugates
New class off drugs designed as a targeted
therapy for treatment of cancers
ADC’s are complex molecules composed of
a Mab linked to a cytotoxic agent
Elements of ADC
7. ADC Production – A journey made safer and faster| 30.11.2021
7
- Suitable quality of parent antibody
- Need to optimize additional process steps that are not present in conventional mAb manufacturing
e.g. the antibody-drug conjugation reaction and subsequent drug substance purification.
- Possible generation of mAb aggregates and drug/linker side reactions, which could lead to
subsequent purification and analytical challenges
- The manufacturing challenges with respect to process, safety and analytical requirements conferred
by conjugation of the biologic to the highly active cytotoxic component.
- Ensuring containment of the highly toxic drug compounds to protect operators and the wider
environment, which presents significant operational difficulties.
Challenges - Technical and Manufacturing
9. 9
Single-use Technology to Streamline Bioprocessing
Faster product changeover
Accelerated time to clinic
or market
Faster implementation
Eliminates cleaning
Validation
Reduced bioburden risks
Reduced cross-
contamination risks
Reduced operator and
environment exposure
Adaptability to changing
process needs
Multi-product
manufacturing facilities
Scalable and movable
platforms
Lower cost: reduced water/caustics,
utilities, equipment downtime, and
unproductive labor
Compact footprint
Lower investment
10. ADC Production – A journey made safer and faster| 30.11.2021
10
Applicability of Single-use Technology for ADCs
Process capability for ADC processes
Compatibility/Extractable Studies
including ADC solvents
Single Use Assembly Testing
− Leak testing
− Biological reactivity - USP <88>,
Class VI
Product Specific Testing
− BioReliance® Extractable and
Leachable Validation Services
11. 11 ADC Production – A journey made safer and faster| 30.11.2021
11
Single-use ADC Process
Reaction
Mobius® / powerMix
10-3000L
UF/DF
Mobius® FlexReady
TF2, TF3 2-10m2
Chromatography
Mobius® FlexReady
0.1 – 8LPM
Formulation/ Filtration
Mobius® /Power Mix and
Filters
10-3000L
Filtration
Opticap® Filter with Millipore Express®
SHC membrane
UF/DF
Mobius® FlexReady TF2,TF3
0.5-10m2
Solvent Component
12. ADC Production – A journey made safer and faster| 30.11.2021
12
Solvent Compatibility Considerations
Solvent composition
Product contact components
Performance testing
− Visual inspection for leaks and physical changes
− Functionality testing
− Sterile filters – verify microbial retention
− Extractables
ADC Single-use Process – Solvent Compatibility
T
Mobius® FlexReady Solution
with Smart Flexware®
Assemblies - Chromatography
13. ADC Production – A journey made safer and faster| 30.11.2021
13
Solvent Compatibility Considerations
Solvent composition
Product contact components
Performance testing
− Visual inspection for leaks and physical changes
− Functionality testing
− Sterile filters – verify microbial retention
− Extractables
ADC Single-use Process – Solvent Compatibility
T
Mobius® FlexReady Solution
with Smart Flexware®
Assemblies - TFF
14. ADC Production – A journey made safer and faster| 30.11.2021
14
ADC Single-use Process – TFF Capsules, Holderless installation
T
T
Plug and Play
Ready to Use in Minutes
Reliable Performance
Reduce…
• Installation time
• Operator error
• Integrity failure risks
Easy connection
• ¾ inch sanitary flange
Self-contained filter
• Easy to install, safe to
remove
• Comparable to cassettes
in terms of scalability,
MOC, screen
Benefits
In parallel set-up
In series set-up
(SPTFF)
15. ADC Production – A journey made safer and faster| 30.11.2021
15
Common ADC Process Solvents
Drug charge to reactor:
− 100% DMSO (Dimethyl Sulfoxide)
− 100% DMAc (Dimethyl Acetamide)
Reaction/Purification composition
− up to 20% DMSO
− up to 20% DMAc
ADC Single-use Process – Solvent Composition
Mobius® Single-use Jacketed Mix 100 L
16. ADC Production – A journey made safer and faster| 30.11.2021
16
ADC Single-use Reactor – Solvent Compatibility
Mix bag components
• Bag film
• Ports
• Mixer
• Tubing
• Sampling valve
Mixer
Sampling
Mobius® MyWay
50L PureFlex™ Mobius® MIX Bag
Ports
Film
Example Mix Bag Components
PureFlex™ Film
Risk assess component exposure to 100% solvent
17. ADC Purification Equipment – Solvent Compatibility
ADC Production – A journey made safer and faster| 30.11.2021
17
Flow path assembly components
• Pump
• Valves
• Instrumentation
• Mix bag
• Sampling
Recovery Line
To Transfer Pump
Smart Flexware® Assembly for TFF
100L Single-use
Feed Container
Assembly
Filtrate Assembly with
Single-use Sensors Flow Cell
Retentate Sampling
Port Assembly
Dow Corning® Pharma-80 Tubing,
used to create bypass loop around TFF
liners and cassettes
Extractable Test Setup on Mobius® FlexReady Solution
with Smart Flexware® Assemblies for TFF
Single-use Feed
Pump Assembly
Test Setup on Mobius® FlexReady Solution with Smart
Flexware® Assemblies for TFF
19. ADC Production – A journey made safer and faster| 30.11.2021
19
After exposure to:
20% and 100% Dimethyl Sulfoxide (DMSO)
20% and 100% Dimethyl Acetamide (DMAc)
Water
Provide understanding on compatibility of selected standard single-use assemblies and components with the
solvents most commonly used in ADC processing
Overview of Compatibility Testing
Evaluate functionality and extractables of:
Mobius® MIX bag made from PureFlex™ film
Opticap® XL filter with Millipore Express® SHC
membrane
Mobius® FlexReady Solution with SMART Flexware®
assemblies for TFF or Chromatography
Lynx® CDR and Lynx® S2S sterile connectors
Colder AseptiQuik® G sterile connectors
Pharma & Biopharma Raw
Material Solutions
20. Mobius® MIX bag testing
ADC Production – A journey made safer and faster| 30.11.2021
20
PureFlex™ film
100% DMSO, 100% DMAc, RO water
24-hour soak in solvent at 40°C
Post-solvent exposure:
No visual changes
No change in bag seam strength
Slight increase in film elongation at break
No negative performance impact expected
In use, bag is supported in a holder
21. Millipore Express® SHC membrane and Opticap® Filter Capsule
testing
ADC Production – A journey made safer and faster| 30.11.2021
21
Millipore Express® SHC 0.5mm / 0.2mm PES membrane
47 mm membrane discs and 5” Opticap® XLT capsule
20% DMSO, 20% DMAc, RO water
24-hour soak in solvent at 40°C
Post-solvent exposure:
No visual or physical changes
Water flow passes specification
Bubble point passes specification
Capsule maintains complete microbial retention (> 9
log reduction of B. diminuta)
ADC Processing using Millipore Express® SHC
(Cat#KHGEG015FF3/Lot#C8DA57941)
Bacterial Retention Test
(B. diminuta;>107 CFU/cm2)
22. Opticap® Filter with Millipore Express® SHC
Extractables Evaluation
ADC Production – A journey made safer and faster| 30.11.2021
22
22
No pre-use flush of capsule
All identified components are from membrane
manufacture or gamma irradiation
In a worse-case process scenario with low filter
throughput (150 L/m2), all extractable components
would be < 0.1 mg/mL in pool
Subsequent diafiltration will reduce even more
Opticap® XL5 Capsule with Millipore Express® SHC Membrane
Non-Volatile Extractables via HPLC-DAD/MS
Opticap® XL5 Capsule with Millipore Express® SHC Membrane
Semi-Volatile Extractables via DI-GC/MS
Opticap® XL5 Capsule with Millipore Express® SHC Membrane
Volatile Extractables via HS-GC/MS
23. Flow Paths and Wetted Materials for Solvent Exposure Testing
ADC Production – A journey made safer and faster| 30.11.2021
23
Recovery Line
To Transfer Pump
Smart Flexware® Assembly for TFF
100L Single-use
Feed Container
Assembly
Filtrate Assembly with
Single-use Sensors Flow Cell
Retentate Sampling
Port Assembly
Dow Corning® Pharma-80 Tubing,
used to create bypass loop around TFF
liners and cassettes
Extractable Test Setup on Mobius® FlexReady Solution
with Smart Flexware® Assemblies for TFF
Single-use Feed
Pump Assembly
Lynx® Connectors Flow Loop AseptiQuik® G Flow Loop
Extractable Test Setup on Mobius ® FlexReady Solution
with Smart Flexware® Assemblies for TFF
24. Flowpaths for Post-Exposure Functional Testing
ADC Production – A journey made safer and faster| 30.11.2021
24
Valve Bypass Test setup #1
Valve Bypass Test setup #2
Valve Cycling Test setup
25. Mobius® Smart Flexware™ and Lynx® Connector Extractables
ADC Production – A journey made safer and faster| 30.11.2021
25
Metals Analysis
Only traces of sodium and calcium were detected
No metals identified are classified as elements to be considered in the risk assessment as outlined in
ICH Q3D Guideline for Elemental Impurities and USP <232> Elemental Impurities
Non-Volatile Organic Analysis
No compounds were detected in any system or solvent combination using LC-MS analysis.
Volatile Organic Analysis
HS-GC/MS analysis for volatile organic compounds indicated no extractable peaks in any system.
Semi-Volatile Organic Analysis
DI-GC/MS analysis for semi-volatile organic compounds did not identify any peaks above 0.05 mg/mL.
Results from DMAc exposure, shown on next slide, represent the highest observed levels of the three
solutions which were tested.
26. Extractables after Exposure to 20% DMAc: Direct Inject GC-MS
ADC Production – A journey made safer and faster| 30.11.2021
26
Extractables after Exposure to 20% DMAc
Smart Flexware® Assemblies and Connectors for Mobius®
systems, Method: DI-GC/MS
1 Mobius® TF-2S Smart Flexware® assembly, 6L recirculation
Extractables after Exposure to 20% DMAc
Smart Flexware® Assemblies and Connectors for Mobius®
systems, Method: DI-GC/MS
All identified compounds are < 0.05 mg/mL
1 TF-2S Smart Flexware® Assembly, 6L recirculation
1 Lynx® CDR and 1 Lynx® S2S, 0.5L recirculation
2 AseptiQuick® G connectors, 0.5L recirculation
28. ADC Single-use End-user / Supplier Collaboration for Success
ADC Production – A journey made safer and faster| 30.11.2021
28
Single-use system design/suitability review:
end user and supplier
• User requirements collaboration session
• Proper selection of standard systems and options
• Review options for single-use assembly custom design
• Users attend supplier demonstration of single-use
equipment
• Outcome: optimal single use-system for application
Supplier training for production success
• Single-use system hardware
• Single-use assembly unpacking and installation
• Key to prevent single use assembly damage
Mobius® Single-use Jacketed Mixers
M Lab™ Burlington, MA
29. Single-use Technology Benefits - ADC Production experience
ADC Production – A journey made safer and faster| 30.11.2021
29
Faster product changeover
Accelerated time to clinic
or market
Faster implementation
Eliminates cleaning
Validation
Reduced bioburden risks
Reduced cross-contamination
risks
Reduced operator and
environment exposure
Adaptability to changing
process needs
Multi-product
manufacturing facilities
Scalable and movable
platforms
Lower cost: reduced
water/caustics, utilities, equipment
downtime, and unproductive labor
Compact footprint
Lower investment
Reduced ADC potent
waste handling/disposal
30. ADC Single-use - Production Experience
ADC Production – A journey made safer and faster| 30.11.2021
30
Platform ADC process equipment
• Standard automated hardware and single use flowpath
assemblies
Examples:
Chromatography and TFF skids, mix bags
• Development of standards for custom designed single use
assemblies - multiple product/process application
Examples:
Bag manifolds with pump tubing, sample bag and filter in
one single use assembly.
Mix bag assemblies for ADC reactor, process blending and
formulation
• Additional benefits
Simplified inventory
Reduce operator training/manual intervention
Reduce autoclave parts
32. Conclusions: Compatibility and Extractables
ADC Production – A journey made safer and faster| 30.11.2021
32
Demonstrated solvent compatibility of the most commonly used ADC conjugation chemicals at conditions that exceed typical
concentrations and exposure times for:
Mobius® Mix bag with PureFlex™ film
Opticap® XL filter with Millipore Express® SHC membrane
Mobius® FlexReady Solution with Smart Flexware® Assemblies for TFF or Chromatography
Mobius Lynx® CDR, Mobius Lynx® S2S Connectors and Colder AseptiQuik® G sterile connectors
After 24 Hour exposure to 20% DMSO or 20% DMAc
No leaks and no physical changes observed by visual inspection
Bags, flexware, connectors, and filters passed all functionality testing including microbial retention
PureFlex™ film maintained performance after 24-hour exposure to 100% DMSO or 100% DMAc
Extractables Profile
No peaks were identified by LC-MS or HS GC-MS for any of the solvent extractions.
Several peaks were visible using DI GC-MS. No compounds were present above 0.05 mg/mL.
No metals identified by ICP that are classified as elements to be considered in the risk assessment
per ICH Q3D Guideline for Elemental Impurities and USP <232> Elemental Impurities
33. Conclusions: Single-use Application for ADC Process
ADC Production – A journey made safer and faster| 30.11.2021
33
A broad range of single-use equipment is available to meet the challenging needs of ADC
production.
Single-use assemblies are compatible with ADC process solutions.
Single-use supplier and end user collaboration is key for successful process application.
Single-use equipment benefits are realized in ADC production.
Use of standard and custom single-use systems allows for an ADC process equipment
platform that meets multiple product/process needs.
34. ADC Production – A journey made safer and faster| 30.11.2021
34
Acknowledgements
Compatibility and Extractables Testing Team
Mobius® Technical support
R&D
Applications Engineering
Bioprocessing
Bio-Conjugation Center of Excellence St. Louis
Global Process & Analytical Development
ADC Production manufacturing
Marcom Team
36. Classification: Public
The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
ADC Production
A journey made safer and faster
Giuseppe Camporeale
Field Marketing Manager - Actives
November 30th, 2021
37. Classification: Public
The life science business
of Merck KGaA, Darmstadt,
Germany operates as
MilliporeSigma in the U.S.
and Canada
39. Classification: Public
Antibody Drug Conjugate Composite
4
Specific for a tumor-associated
antigen that has restricted
expression on normal cells.
Designed to kill target
cells when internalized
and released.
Attaches the cytotoxic agent to the
antibody and are designed to be stable in
circulation and release the cytotoxic agent
inside targeted cells.
Antibody
Payload
Linker
Enhanced
safety
profile and
improved
therapeutic
index for
the patient
Three main components that must be optimized
ADC Production – A journey made safer and faster| 30.11.2021
40. Classification: Public
What would an ideal CDMO for ADC production look like?
The perfect travel companion
Have an integrated offering to perform as many steps as possible
They guarantee the highest quality standards
They can support with Regulatory procedures
They can produce and handle single ng OEL compounds
They provide innovative solutions to technological pitfalls
5 ADC Production – A journey made safer and faster| 30.11.2021
41. Classification: Public
Our Comprehensive Solution
ADC Overview
6
6
Biodevelopment
Center
Massachusetts, USA
Biodevelopment
Center
France
Biodevelopment
Center
China
ADC & Bioconjugation
Suites
Missouri, USA
HPAPI
Manufacturing
Complex
Wisconsin, USA
Biopharmaceutical Testing Services
Maryland, USA
Scotland, UK
PEGs
Switzerland
Monoclonal Antibody
▪ Development
▪ GMP Mfg.
▪ Testing
Payload & Linker
▪ Development
▪ GMP Production
▪ PEGs
▪ Development
▪ GMP Production
Bioconjugates
▪ Development
▪ GMP Manufacturing
▪ Testing
42. Classification: Public
We support ADC production in every development phase
Comprehensive Solution Provider
7
ADC Express™
St. Louis (MO, US)
43. Classification: Public
mAb production and Testing
Pre-clinical Phase I Phase II Phase III Commercial
Cell line development
Any mammalian cells
Analytical development
Process development
Templated or customized
GMP Clinical Manufacturing
Single-Use 50 to 2,000 L scale
Facility design, equipment commissioning
Process validation, scale up, TT
Cell banking
Characterization testing Lot Release testing
46. Classification: Public
Chasing the Nanogram Limit
Evolution of CPT target level for HPAPI Certification
Cat 3
<10µg/m3
Cat 4
<30 ng/m3
<10 ng/m3
<1 µg/m3
2004 containment level
2018 containment level
CPT results needed for HPAPI certification
Cat 1
<5 mg/m3
Cat 2
<0.5 mg/m3
• Early containment performance
testing required equipment to
achieve surrogate levels at
<1 µg/m3
• Industry shift in ca. 2010 required
performance targets to become more
restrictive to adapt to industry trend
towards lower OEL materials, namely
ADC Linker/Payloads
• In 2018, additional clinical data for
several ADCs indicated that these
compounds had lowered OEL levels
(<10 ng/m3). This required tighter
CPTs and equipment changes for
safe handling
• Today, 90% of all global
Linker/Payloads for ADC programs
require <10 ng/m3 containment
Takeaway
2010 containment level
<30 ng/m3
47. Classification: Public
Strategic provider of linker-payloads
for use in Antibody Drug Conjugates
1
2
3 Large scale manufacturing (200 – 800L)
of complex APIs and HPAPIs down to 30
ng/m3 OEL
12
Advancing Pharma Development and Impacting Patients
Madison/Verona is a Premier Supplier of Pre-clinical to Commercial APIs and HPAPIs
Antibody
Linker
Payload
4 Center of Excellence for large scale
chromatography of difficult to separate
compounds
Lab scale manufacturing (≤ 50 L) of HPAPIs
(SafeBridge certified since 2003) with
potencies down to 5 ng/m3 OEL.
48. Classification: Public
Verona Expansion Overview
13
Capacity Required for HPAPI Customers and Downstream
ADC Manufacturing
Investment includes 6 best-in-class HPAPI kilo labs (<10 ng/m3 OEL containment), QC lab, and
administrative space
6,400 m2 addition will be attached to existing Verona facility, and will be ISO8 classified
ADC production – Nov 30th, 2021
49. Classification: Public
2/3 of payloads arise from 2 Commonly Used Classes
14
Payloads Used in ADC Development
Tubulin inhibitors
Derived from a sea hare
5 Commercial ADCs
Maytansines
Dolastatins
Tubulin inhibitors
Derived from an African shrub
1 Commercial ADC
ADC production – BioP APAC Symposium – Nov 18th, 2021
50. Classification: Public
DOLCore™ and MAYCore™ Provide Exceptional Value
Versatility
DOLCore™
can be
modified to
meet your
specific
linker-
payload
needs
Speed
DOLCore™
reduces the
number of
synthesis
steps from
15-20 to
four or
fewer
Reduced-
risk
Supply chain
risk reduction
– Ready
stock
available
Free
Samples
Free
samples!
5 g –
Available
now!
Reg.
Support
Phase
appropriate
regulatory
documents
available
Royalty-free
Royalty-free
license
Exclusivity
Earlier
market
exclusivity of
the
commercial
drug
DOLCore™
Average
increase in
sales revenue
of $175M
USD*
*Based on time
savings of developing
a phase 1 candidate
using DOLCore™ vs. a
traditional approach
and average 2020
sales revenue of
commercial ADCs
MayCore™
15 ADC Production – A journey made safer and faster| 30.11.2021
51. Classification: Public
Solid quality and regulatory platform – DMF/Dossier
Supply chain complexity reduced – Flexibility
Advantages of the payload core platform include
speed to market and FTO - Years
1
2
3
16
Imagine starting a marathon at mile 21…
53. Classification: Public
Monodisperse PEGs for ADC conjugation in Schaffhausen, CH
18
GMP aPEG Manufacturing for Clinical and Commercial Use
Production of pure & functionalized PEGs with
standardized molecular weight; 4-24 PEG units
Application as ADC linker to improve solubility and
achieve optimal Drug to Antibody ratios (DAR)
High product quality from grams to tons produced
at an FDA-inspected site
Customized product development & extensive
analytical capabilities
Regulatory expertise from our dedicated team
ADC Production – A journey made safer and faster| 30.11.2021
54. Classification: Public
19
A solution is needed for the hydrophobicity problem
Requires lowering of
DAR
Subsequent loss of
efficacy and smaller
therapeutic window
Side effects
Major modifications needed:
Drug-to-antibody ratio (DAR)
Change formulation
Payload selection
Conjugation site
Increased use of co-solvent Project termination
Additional investments needed
(time, $/€, people)
Increased development risk
Potential IP / FTO restraints
Further development
ADC poorly soluble
Implications
Solubility is a technical obstacle for today’s ADC
“I am aware of two Small Biotechs that even
went bankrupt because they could not
solve the solubility issue”
- Tier 1 US-based Univ. professor -
55. Classification: Public
Our Chito-oligosaccharide enhances solubility
Consider it Solved!
20
ChetoSensar™ is a
drug enabler
ChetoSensar™
Technology
Chito-oligosaccharide
Payload (=drug)
Antibody
Linker
20 ADC Production – A journey made safer and faster| 30.11.2021
56. Classification: Public
Incorporating Chetosensar™ into an ADC reduces hydrophobicity
0 5 10 15 20 25
m
AU
0
20
40
60
80
100
120
D
AD
1 A, Sig=280,4 R
e
f=o
ff (IS18IS018 2018-01-23 08-05-23_H
IC
18IS0180000003.D
)
10.631
D
AD
1 A, Sig=280,4 R
e
f=o
ff (IS18IS018 2018-01-23 08-05-23_H
IC
18IS0180000010.D
)
11.984
13.928
D
AD
1 A, Sig=280,4 R
e
f=o
ff (IS18IS018 2018-01-23 08-05-23_H
IC
18IS0180000018.D
)
m
0 5 10 15 20 25
mAU
0
20
40
60
80
100
120
DAD1 A, Sig=280,4 Ref=off (IS18IS018 2018-01-23 08-05-23_HIC18IS0180000003.D)
10.631
DAD1 A, Sig=280,4 Ref=off (IS18IS018 2018-01-23 08-05-23_HIC18IS0180000008.D)
12.168
14.141
DAD1 A, Sig=280,4 Ref=off (IS18IS018 2018-01-23 08-05-23_HIC18IS0180000015.D)
Hydrophilic
hydrophili
c
Hydrophobic
t/min
ADC
Absorption
Antibody alone
ADC + Chetosensar™
Antibody alone
Chetosensar™
21
57. Classification: Public
0
400
800
1200
1600
2000
31 41 51 61 71 81 91
Tumor
Volume
in
mm³
days
Vehicle, PBS
vc-MMAE w/o CO
vc-MMAE w/ CO
With 1/3 of dose, ChetoSensar™ conjugated ADC gives same result as standard ADC
At same dose, ChetoSensar™-ADC led to rapid and complete tumor regression
Median results report from a group of 8 mice
Key Takeaways
22
Xenograph Models - MMAE with and without Chetosensar™
Incorporating Chetosensar™ improves ADC efficacy
ADC Production – A journey made safer and faster| 30.11.2021
59. Classification: Public
24
Connect the Dots
cGMP ADC and Bioconjugation Services
Dedicated assets for ADC development,
manufacturing, and testing:
Platform Experience with over 80 different
constructs and 180 GMP runs
Random cysteine or lysine conjugation
technology
Site directed conjugation via engineered mAbs,
enzyme catalyzed or non-natural amino acids
(NNA)
Various payloads: auristatins, PBDs,
tubulysines, maytansinoids, non-potent APIs
Extensive analytical capabilities
First Commercial ADC facility in US to get
FDA successfully inspected
ADC Production – A journey made safer and faster| 30.11.2021
60. Classification: Public
Production of development grade ADC constructs for candidate
selection
Leverage established bio-conjugation process & analytical
chemistry platforms
Mini-prep scale – 10-20 mg ADC construct ± column
purification
Medium-prep scale – up to 100 mg ADC construct ± column
purification
Deliverables to customer:
− ADC constructs
− Certificate of testing with key quality attributes
− ADC concentration
− Payload density – DAR
− Monomer / aggregate content
− Residual free payload
− Endotoxin
25
Accelerate your timeline with ADC ExpressTM
61. Classification: Public
ADC ExpressTM vs. Development and GMP Production
26
Development (GLP)
ADC ExpressTM
GMP Production
Medium to high throughput
3mL to 25mL test tubes
Multiple constructs
prepared and delivered
Turn around time – 6 to 8
weeks
Single construct delivered per
project
One batch produced at a time
10L to 500L reactors
Turn around time – 3 to 6 months
Single construct delivered per
project
500mL to 10L reactors
Turn around time – 3 to 6
months
6-12 months Seamless
63. Classification: Public
We support ADC production in every development phase
Comprehensive Solutions Provider
28
Who will be your trusted ADC journey companion?
We can support an ADC production E2E
We can operate at the most appropriate quality standards
We can support with Regulatory procedures
We can produce and handle single ng OEL compounds
We provide innovative solutions to technological pitfalls