In this webinar, we will discuss:
• The application of RNA therapeutics and the different drug delivery routes used in the clinic.
• Design principles for developing lipids-based RNA formulations.
• Critical parameters to consider for cost effective development and consistent performance of RNA therapeutics and vaccines.
RNA therapeutics are changing the way we address diseases. Applications range from gene therapy, oncology, to vaccines for infectious diseases such as COVID-19.
The performance of RNA therapeutics critically depends on its formulation. Key decisions have to be made early on in the drug development process; choosing the appropriate drug delivery method and novel excipients. Raw material source and judicious choice of chemistry, ultimately determine the quality of novel lipid excipients which, in turn, has a big impact on the performance, reproducibility, costs, and regulatory approval timelines. This webinar will propose solutions to maximize the probability of success while formulating RNA therapeutics and vaccines.
Participate in the interactive webinar now: https://bit.ly/2xXMZlm
Explore our webinar library: www.emdmillipore.com/webinars
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
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
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
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
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
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
Presentation at "2016 Osong BioExcellence - Renaissance in Immunotherapy" at South Korea, an event jointly hosted by Kbio Health and Merck on 6th October 2016.
Validation of Tangential Flow Filtration in Biotech ProcessesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3hUKfd7
The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn:
• Validation of TFF
• Validation master plan
• Membrane reuse and cleaning
• TFF scale down models
Speaker: Dr. Subhasis Banerjee,
Principal Technical Application Expert, Bioprocessing APAC
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
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
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
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
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
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
Presentation at "2016 Osong BioExcellence - Renaissance in Immunotherapy" at South Korea, an event jointly hosted by Kbio Health and Merck on 6th October 2016.
Validation of Tangential Flow Filtration in Biotech ProcessesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3hUKfd7
The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn:
• Validation of TFF
• Validation master plan
• Membrane reuse and cleaning
• TFF scale down models
Speaker: Dr. Subhasis Banerjee,
Principal Technical Application Expert, Bioprocessing APAC
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.
Complete single-use ADC technology from development through scale-up MilliporeSigma
This webinar will talk about the benefits of single-use technologies for the manufacturing of antibody-drug conjugates and present a successful corresponding case study.
With an expected high annual growth rate of the global Antibody-drug Conjugate (ADC) market, it is essential that CMO’s have robust manufacturing platforms to ensure successful transfer to GMP production.
Single-Use Technologies provide many advantages, including improved safety, lower costs and greater flexibility. This webinar will outline the advantages of a Single Use Platform and give a case study on how it can be used to manufacture ADC projects.
In this webinar, you will learn:
● How single-use technologies can provide benefits for ADC manufacturing
● Why a solid manufacturing platform is crucial for a successful transfer to GMP production
● How a case study demonstrates the advantages of single-use equipment in a scale up to GMP production
Vaccine Cell Bank and Virus Seed CharacterizationMilliporeSigma
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination
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
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.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...Merck Life Sciences
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest process technologies within innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
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
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
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Innovation in Filter Validation and Technology TransferMilliporeSigma
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early stage products that do not have the quantity of material required to easily and efficiently perform such testing. Process and product parameters were varied to determine their effect on microbial retention.
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
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMerck Life Sciences
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
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.
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Extractables profiles for chromatography resins - adapted approach of upcomin...Merck Life Sciences
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
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
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...MilliporeSigma
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...Merck Life Sciences
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
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.
Complete single-use ADC technology from development through scale-up MilliporeSigma
This webinar will talk about the benefits of single-use technologies for the manufacturing of antibody-drug conjugates and present a successful corresponding case study.
With an expected high annual growth rate of the global Antibody-drug Conjugate (ADC) market, it is essential that CMO’s have robust manufacturing platforms to ensure successful transfer to GMP production.
Single-Use Technologies provide many advantages, including improved safety, lower costs and greater flexibility. This webinar will outline the advantages of a Single Use Platform and give a case study on how it can be used to manufacture ADC projects.
In this webinar, you will learn:
● How single-use technologies can provide benefits for ADC manufacturing
● Why a solid manufacturing platform is crucial for a successful transfer to GMP production
● How a case study demonstrates the advantages of single-use equipment in a scale up to GMP production
Vaccine Cell Bank and Virus Seed CharacterizationMilliporeSigma
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination
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
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.
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...Merck Life Sciences
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest process technologies within innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
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
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
In this webinar, you will learn:
Sources of endotoxin contamination
Contamination control strategy
Endotoxin removal strategies
Detailed description:
Endotoxin, a lipopolysaccharide (LPS), is a type of pyrogen and is a component of the exterior cell wall of Gram-negative bacteria. To ensure safety on patient’s endotoxin content in the drug should always be controlled. In a biological processing it may emanate from facility, utility, raw materials, process, and personnel. In this webinar we discuss the regulatory norms, strategies for prevention & removal of endotoxin to ensure that the final drug product is safe.
Innovation in Filter Validation and Technology TransferMilliporeSigma
Regulatory and manufacturing requirements exist to perform product-specific microbial retention testing on sterilizing filters. The implementation of a Quality by Design approach to microbial retention testing supports a paradigm that would obviate the need for product-specific testing for early stage products that do not have the quantity of material required to easily and efficiently perform such testing. Process and product parameters were varied to determine their effect on microbial retention.
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
Parvovirus Filtration Best Practices - 25 Years of Hands-On ExperienceMerck Life Sciences
In this webinar, you will learn:
- how to measure filter performance and capacity,
- how to optimize filter virus removal capability,
- and avoid potential pit-falls
Detailed description:
This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
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.
Abstract:
Cell and gene therapies, well recognized as the drug revolution for this decade, are booming in Asian countries. Several cell and gene therapeutic products launched successfully in Europe and the US. The commercialization of these therapies is a hot topic, while ensuring product safety, especially quality for the new modalities, raises challenges within the industry. As a globally leading biosafety testing provider, Merck is committed to optimizing and advancing innovation and development of biosafety testing. As your reliable partner in CMC consideration, our comprehensive solutions for cell and gene therapy biosafety testing enable regulatory compliance. This presentation will cover rationale and methodologies for cell and gene therapy product testing from Merck’s BioReliance® testing portfolio, as well as provide an overview of our testing capabilities and services.
Extractables profiles for chromatography resins - adapted approach of upcomin...Merck Life Sciences
Watch the webinar here: https://bit.ly/36JaZpx
In biopharmaceutical industry there is a trend towards comprehensive risk assessments of drug manufacturing processes. Extractables studies for chromatography resins based on the adapted requirements of the upcoming USP <665> support risk evaluation for your specific chromatography steps.
In this webinar, you will learn about:
- Study design for extractables profiles of chromatography resins
- The new category Emprove® Chromatography
- Communication of extractables data as part of Emprove® Dossiers
Description:
Detailed information on any component or material in contact with the drug substance/ product is required to conduct a compreshensive risk assessment of a biopharmaceutical manufacturing process. No explicit guidelines providing required testing procedures for chromatography steps are in place yet. In the upcoming USP <665> chapter chromatography steps are in focus as well as any other plastic or polymeric component and can as such assessed as to the described criteria. To support our chromatography resin users an adapted extractables study approach was developed. The webinar will demonstrate our study design and the communication of the extractables profiles within our Emprove® Program.
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
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...MilliporeSigma
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
Successful Drug Development with Synthetic Lipids: Critical Aspects and Strat...Merck Life Sciences
Lipid-based formulations and lipid nanoparticles are administration strategies of increasing importance in the pharmaceutical world. On the way to a successful drug product registration, there are numerous challenges to be overcome – from formulation development to meeting regulatory requirements and submission. In particular, care must be taken to choose appropriate lipids with respect to their type, source and quality, as these factors greatly affect the performance of the final formulation and also play a role in financial considerations.
In this webinar, you will:
● Explore critical aspects relating to synthetic lipids as raw materials for lipidic formulations
● Learn strategies to minimize risk when choosing lipidic raw materials for drug product development
● Gain insights into tailored manufacturing and lipids with optimized properties such as conjugation of targeting moieties
Specialized in custom synthesis of organic molecules. Broad experience of working on multiple business models - FTEs, FFS, Milestone services of pharmaceutical industry.
Commited to deliver highest quality products in a timely manner and value to the customers.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Excipients selection for high risk formulations Smita RajputMilliporeSigma
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...Merck Life Sciences
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
Laxmi Genchem Sciences Pvt Ltd is contract research & generic API manufacturing organization that services global pharma industry; is operated in Hyderabad, INDIA. Established in 2013, has a rich experience in a focused business to rapidly assist our partners in development of NCEs & Generic API non-fringing route scouting; will support the commercial manufacturing with all global regulatory requirements;A Global company in its aspiration with a focus on all stake holders, the employees, the customers and finally the consumers of the products (finished dosages) that carry our quality Ingredients.
Creating knowledge, building strong intellectual base, cultivating an environment with values such as respect, diligence and strong sense of creativity shall be our hallmarks.
Visit us:
www.laxmigenchem.com
Designed to attract experts working in all areas of medicinal chemistry and molecular pharmacology the summit has five tracks focusing on key issues such as optimising hit to lead quality and timescale, protein degradation, DNA Encoded libraries, GPCR’s, small molecule Immuno-oncology research, FBDD, SBDD, CADD as well as best strategies for partnerships, collaborations, outsourcing and integration of research. The Summit will provide a forum to network, learn and engage with senior representatives of leading pharmaceutical and biotech companies worldwide. It is a gathering not to be missed!
The Butterfly Effect: How to see the impact of small changes to your ADCMilliporeSigma
Watch this webinar here: https://bit.ly/31PRr2z
Small changes to the design of antibody-drug conjugate can have a dramatic effect on its structure and biological activity. Effective product characterization is essential to understanding the impact of these changes. Here we discuss methods to provide insight at critical junctures in ADC development.
There are many different design considerations facing developers of antibody-drug conjugates: these variables must be tuned to achieve the right balance of efficacy and safety. For example, the choice of linker can influence an ADC's potency, toxicity and pharmacokinetics.
In this webinar we explore the influence of various PEG linkers on the structure of a model ADC by identifying specific sites of conjugation by peptide mapping, investigating changes in higher order structure by HDX mass spectrometry, and examining the impact on binding by SPR spectroscopy.
We demonstrate that employing a range of orthogonal methods is critical to understanding the structure-function relationships of an ADC.
In this webinar, you will learn about:
• How the choice of linker can influence an ADC's activity
• Information-rich methods to probe ADC structure and function
• Effective strategies for thorough characterization of ADC products
The Butterfly Effect: How to see the impact of small changes to your ADCMerck Life Sciences
Watch this webinar here: https://bit.ly/31PRr2z
Small changes to the design of antibody-drug conjugate can have a dramatic effect on its structure and biological activity. Effective product characterization is essential to understanding the impact of these changes. Here we discuss methods to provide insight at critical junctures in ADC development.
There are many different design considerations facing developers of antibody-drug conjugates: these variables must be tuned to achieve the right balance of efficacy and safety. For example, the choice of linker can influence an ADC's potency, toxicity and pharmacokinetics.
In this webinar we explore the influence of various PEG linkers on the structure of a model ADC by identifying specific sites of conjugation by peptide mapping, investigating changes in higher order structure by HDX mass spectrometry, and examining the impact on binding by SPR spectroscopy.
We demonstrate that employing a range of orthogonal methods is critical to understanding the structure-function relationships of an ADC.
In this webinar, you will learn about:
• How the choice of linker can influence an ADC's activity
• Information-rich methods to probe ADC structure and function
• Effective strategies for thorough characterization of ADC products
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...MilliporeSigma
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 PurificationMilliporeSigma
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...MilliporeSigma
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...MilliporeSigma
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...MilliporeSigma
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...MilliporeSigma
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
The Future of Pharma- and Biopharmaceutical AuditsMilliporeSigma
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...MilliporeSigma
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 therapiesMilliporeSigma
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...MilliporeSigma
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
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
How does the ICH Q5A revision impact viral safety strategies for biologics?MilliporeSigma
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...MilliporeSigma
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...MilliporeSigma
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 SystemsMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot ...MilliporeSigma
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
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...MilliporeSigma
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...MilliporeSigma
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
How to Accelerate and Enhance ADC TherapiesMilliporeSigma
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
Key to Successful Formulation Development for Lipid Based RNA Delivery and Vaccines
1. The life science business of Merck KGaA,
Darmstadt, Germany operates as
MilliporeSigma in the U.S. and Canada.
Key to successful
formulation development
for lipid based RNA delivery
and vaccines
Webinar 2020
Shiksha Mantri
2. The life science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.
Key to successful lipid-based RNA formulations | 09.04.20202
3. Agenda
1. Introduction
Benefits and considerations for RNA therapeutics
2. Critical parameters defining activity of lipid-based formulations
Composition, source, quality, formulation process
3. Essential considerations for successful drug development
Timing, regulatory aspects, number of sources, supplier choice
4. Summary and Q&A
4. Agenda
1. Introduction
Benefits and considerations for RNA therapeutics
2. Critical parameters defining activity of lipid-based formulations
Composition, source, quality, formulation process
3. Essential considerations for successful drug development
Timing, regulatory aspects, number of sources, supplier choice
4. Summary and Q&A
5. Central dogma of molecular biology
RNA as API
Cell
Nucleus
Cytoplasm
How can RNA be a drug?
• DNA/RNA/ protein – all can be APIs
• RNA has several advantages over DNA
or proteins as API
• Rapid and transient protein
production
• No risk of insertional mutagenesis
• Cytoplasmic activity
RNAi
DNA
mRNA
Protein
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020 Image from Wikicommons5
6. Antigen/ protein production
Gene silencing/ activation
Enzyme replacement therapy
Therapeutic antibodies
Gene editing: CRISPR/Cas tech
RNAs as API expand the range of druggable targets
RNA as API – Introduction
Vaccines
Cancer
Pulmonary
Liver metabolic disorders
Precision medicine (various indications)
Small RNAs: siRNA,
shRNA, saRNA, ASO,
etc.
Long RNAs: mRNA
RNA as an API can be used for a variety of applications and indications
Abbreviations used:
siRNA - short interfering RNA; shRNA - small hairpin
RNA; saRNA - short activating RNA; ASO - antisense
oligonucleotides; mRNA - messenger RNA
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 20206
7. Example: COVID-19
RNA therapeutics
1
2
3
Antigen delivery
mRNA
Halt viral replication
RNAi
Antibody
mRNA
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
mRNA of
antigen
mRNA(s) of
antibody
Pathogen mRNA
7
8. When can RNA Tx and vaccines work?
Encapsulation
techniques
Chemical
modifications
ASO
siRNA mRNA
sgRNA
Abbreviations used: siRNA - short interfering RNA; sgRNA – Single
guide RNA; ASO - antisense oligonucleotides; mRNA - messenger RNA
Kowalski, et al. (2017) Genome Medicine 9(1): 60
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Known gene
target
RNA should
reach site of
activity
Two main
strategies
Stability
Immunogenecity
Charge
Size
Endosomal escape
8
9. Applicability
Comparison between different methods for RNA delivery
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Chemical modifications Encapsulation
Vs.
Naked (chemical modifications to
backbone, nucleotides)
GalNac (chemical conjugation to
targeting moeity such as GalNac)
Lipids
Polymers, inorganic NPs, hybrid formulations
Viral
Others
Abbreviations used: GalNac: N-Acetyl-D-galactosamine, ERT: Enzyme replacement therapy
Short RNAs, i.e. ASO, miRNA, siRNA Applicable to all, including mRNA
Naked: broad, by local delivery
GalNac: limited, hepatocyte targeting
Very broad incl. CRISPR, vaccines,
ERT, etc.
API
Delivery
method
9
10. Encapsulation via electrostatic interactions
Choices of delivery vehicles
Lipids
Lipoplexes
Lipid NPs
Most advanced
Granot, Y. and D. Peer (2017). Seminars in Immunology 34: 68-77.
Active RNA pipeline,
by delivery method
35
113
(30.0%)
47 81
7
94
Lipids
Naked
Galnac
Polymer
Viral Vector
Other (e.g. Gold NP)
Pre-clinical 78
Ph I 25
Ph II 7
Ph III 2
Commercial 1
Liposomes
Sources: Clinical trials: Clinicaltrials.gov, preclinical: Pharmacircle
Liposome Lipid nanoparticle (LNP)
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Versatile drug delivery system
Co-delivery of multiple RNAs, small molecule drugs
Plug & play
Immunostimulation
Lipoplex
10
11. Agenda
1. Introduction
Benefits and considerations for RNA therapeutics
2. Critical parameters defining activity of lipid-based formulations
Composition, source, quality, formulation process
3. Essential considerations for successful drug development
Timing, regulatory aspects, number of sources, supplier choice
4. Summary and Q&A
12. Planning transition from Lab → GMP → full scale
Typical formulation process
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
GMPLab conditions
RNA
aqueous
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
Buffer exchange/
dialfiltration/
sterlization
+
Formulation
process
Full scale= =
12
13. Key parameters that affect activity of the final formulation
Composition of
delivery vehicle
Quality of
components
Synthesis route Formulation
process
Performance
Performance = Activity, Stability, Success
1 3
2 4
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 202013
14. Ratio and type of lipids is critical
1. Composition of delivery vehicle
• Encapsulation
• Release
• Influences toxicity
• Structure
• Fusogenicity
• Reduces toxicity
• Stability
• Cargo release
• Immunogenicity
• Structural integrity
• Which Cationic/ Ionizable lipid: Structure defines potency,
targetability, immune response
• Which anionic/ neutral lipid?
• Which PEG lipid: Optimal lengths of C-chain and PEG required
• Animal-derived or Synthetic Cholesterol?
Lipid nanoparticles
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Cationic/
ionizable lipid
1
Anionic/neutral
lipid
2
PEG lipid
3
Cholesterol
4
Parameters to decide:
✓ Which lipids?
✓ Lipids ratios
✓ N/P ratio
✓ Administration route
14
15. Features to keep in mind while designing new ionizable lipids
Ionizable lipids design
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Ramishetti et al. Adv. Mater.2020, Heyes et al. J Control Release. 2005, Hassett et al. Molecular Therapy: Nucleic Acids 2019,
Rietwyk et al. ACS Nano 2017
Consider:
• Number and position of
double bonds in lipid chains
• Branched vs. Linear
• Ester groups within the lipid
chain
Consider:
• Cleavable groups for
degradability such as
esters, amides
Consider:
• Number of amine groups, type
• Shape – cyclic/ linear
• Substitution pattern of the
amine groupLinker
• In vivo efficacy
• Biodistribution
Lipid chain
• Phase transition temp.
• Fusogenicity
• Biodegradability
Head group
• pKa, shape
• Transfection efficiency
• Biodistribution/ Targetability
• Immune system activation
Dlin-MC3-DMA
15
API
Application
Administration
route
Target cell
type
16. 2. Synthesis route/ Process for a novel lipid structure
Points to consider for manufacturing a new lipid:
• How facile is the chemical synthesis? Yield?
• What is the final purity? Are isomers being produced?
• Is the reaction scheme consistently reproducible?
• Is the process scalable?
• Which steps should be done in a GMP environment?
• Detect and identify
impurities: HPLC-CAD
• Endotoxins/ Bioburden
• Solubility tests
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Cost =
Number of chemical steps
Overall yield
Cost of starting materials
Scale of reaction
Analy-
tics
=
16
17. Final GMP process needs to be scalable and reproducible
2. Synthesis route/ Process
1
Reduce number of synthesis steps
Define GMP steps
2
Avoid reaction conditions that lead to isomerization
Yield and quality should be reproducible
3
Consider scalability, economy of scale, batch size
early on
We
recommend
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 202017
18. Quality
Convenience, reproducibility, stability, release profile of formulation
3. Quality of lipids
• Crystallinity
• Solubility
• Stability
• Flowability
Consistency
• Lipid & DP
stability
• Expected
drug release
profile
• Reproducible
results
• Avoiding
bridging
toxicity
studies
Good material
characteristics
High
purity
Expected results
No regulatory hurdles
Cost-saving
Ease of drug product manufacturing
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
implies
means
18
19. Process development → quality
Examples
DOPE
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
• Free flowing powder
• Fast and complete dissolution
• Lumps, gel & foam
• Limited solubility even after lyophilization
Powder DOPEWax-like DOPE
DOPC
• Enhanced stability: >7 years at 25°C / 60% rH
• Fast dissoluton rate
• Easy handling
Crystalline DOPC*Amorphous DOPC
5 mW
19
20. Consistency required in every step of process
How to achieve consistent quality?
1
2
• Low level of by-products
• Defined stereochemistry (cis/trans)
• Low bioburden and endotoxin levels
• Plant-derived raw materials with BSE/TSE and non-GMO
certificates
• Use class II and III solvents
Appropriate manufacturing process
High and consistent quality raw
materials
• Manufacturing under GMP environment, ICH Q7 guidelines
• Optimal reaction conditions
• Defined batch sizes
3Good purification process
• Purification steps must be scalable as well
• Use crystallization if possible
• Employ liquid/liquid extraction methods
• Avoid chromatography
• Convert chromatography into filtration over silica gel
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 202020
Picture of one of our kilolabs in Switzerland
21. Key parameters that affect activity of the final formulation
Composition of
delivery vehicle
Quality of
components
Synthesis route Formulation
process
Performance
1 3
2 4
Performance = Activity, Stability, Success
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 202021
22. Formulation process should be reproducible and scalable
4. Formulation process
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Characteristics, Stability, PerformanceProcess conditions
RNA
aqueous
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
bulk
Buffer exchange/
dialfiltration
LNPs
Final DP
Lyophilization/
fill & finish
+
Formulation
process
DP= drug product22
23. Points to consider
Role of formulation conditions
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Characteristics, Stability, PerformanceProcess conditions
Formulation
process
RNA
aqueous
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
bulk
Buffer exchange/
dialfiltration
LNPs
Final DP
Lyophilization/
fill & finish
+
DP= drug product
Formulation process
• Formulation technique
• Thin film hydration
• Detergent removal
• High pressure homogenization
• Solvent injection
23
24. Formulation techniques
Recap
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Lipids in organic solvent
Drying step Hydration
Addition of water
(and hydrophilic drug/ antigen)
Stirring
Sonication
Extrusion
Homogenization
Multilamellar vesicles Unilamellar vesicles
Lipid film / cake
+ Purification
Thin film hydration
Solvent injection
Lipids in
organic
solvent
RNA in
aqueous
solution
Mixing
P P
P = pump
Dia/ultrafiltration
Mixing
Cross-flow mixing (Polymun)
Microfluidics mixing
24
25. Effect of formulation technique
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Ethanol injection
EtOH injection
+Extrusion
Cross-flow
(Polymun)
Homogenization
Dry film
hydration+
homogenization
Formulation technique Results
Data from Dr. Finn Bauer, Dr. Michael Plastcher, with Polymun, Wagner et al., J Liposome Res 2006 16(3):311-9
Formulation technique effects:
• Size, PDI, encapsulation efficiency
• Costs
• Speed
• Reproducibility
• Scalability
• Stability (for e.g. high pressure
homogenization →Lipids
oxidation, hydrolysis)
25
26. Points to consider
Role of formulation conditions
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Characteristics, Stability, PerformanceProcess conditions
Formulation
process
RNA
aqueous,
low pH
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
bulk
Buffer exchange/
dialfiltration
LNPs
Final DP
Lyophilization/
fill & finish
+
DP= drug product
Formulation process
• Flow rate, injection
hole diameter
• Mixing speed
• Process temperature
Lipid concentration
• Size, PDI
N/P ratio
Solvent injection
26
27. Points to consider
Role of formulation conditions
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Characteristics, Stability, PerformanceProcess conditions
RNA
aqueous,
low pH
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
bulk
Buffer exchange/
dialfiltration
LNPs
Final DP
Lyophilization/
fill & finish
+
Formulation
process
DP= drug product
Duration,
Temperature
pH
• Lipid hydrolysis
→ leaky bilayer → drug
release kinetics → stability
Equipment, conditions
• For filtration, sterilization
• Type, size of filters used
27
28. Points to consider
Role of formulation conditions
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
Characteristics, Stability, PerformanceProcess conditions
DP= drug product
Storage conditions
• Buffer composition, pH,
ionic strength, Storage
vials
Process, conditions
• Cryopreservants
• Inert gas
• Vial type, size, volume
RNA
aqueous
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
bulk
Buffer exchange/
dialfiltration/
sterlization
LNPs
Final DP
Lyophilization/
fill & finish
+
Formulation
process
28
29. Points to consider
Role of formulation conditions
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
RNA
aqueous
Lipids
Organic
solvent
LNPs
Pre-bulk
LNPs
bulk
Buffer exchange/
dialfiltration
LNPs
Final DP
Lyophilization/
fill & finish
+
Formulation
process
pH, Temperature, pressure
Lipid concentration
N/P
Storage conditions
DP= drug product
Hold times, process
parameters
Require appropriate analytical methods
to identify critical process parameters
29
Characteristics, Stability, PerformanceProcess conditions
30. Analytical tests required
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
FDA guidance for industry on liposomal drug products, 2018
Identifying and quantifying drug product
compounds, degradation products
Lipid identity, impurities, quantity
Residual solvents
Parameters of the contained drug
Chemical
Biological
Sterility
Endotoxins measurement
30
Physical
Size, PDI
pH, osmolality
Zeta potential
Phase transition temperature
Particulate matter
31. Agenda
1. Introduction
Benefits and considerations for RNA therapeutics
2. Critical parameters defining activity of lipid-based formulations
Composition, source, quality, formulation process
3. Essential considerations for successful drug development
Timing, regulatory aspects, number of sources, supplier choice
4. Summary and Q&A
32. 1. Research
composition, formulation process
2. Feasibility studies
process research, gram scale manufacture
3. Process optimization
yield, critical raw materials, stability studies
4. Scale up
analytical methods implementation, cleaning, packaging, safety, GMP runs
5. Process maturation
process validation, risk analysis, intermediates
Timing is key
Synchronize product development with drug development
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
3-15 years for 1 drug approval
Approved drug
FDA approval
Post marketing
surveillance
T= 0
1-6 years
2-7 years
0.5-2 years
Drug discovery
Preclinical
Clinical
trials
Drug discovery
Clinical
trials
Planning product development
32
33. Plan ahead
Tips to accelerate drug approval process
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
✓ Data: Perform all pre-clinical and clinical tests
✓ Products specific documentation:
Descriptions of manuf. process, components, in-
process controls, DMF – not necessary
✓ Consistent quality: changes and their clinical
relevance need description
Before market approval:
✓ Validated processes, analytical methods,
impurities identified and specifications (ICH Q3A
and ICH Q6A guidelines, respectively)
✓ 3 stability studies of each lipid and formulation
Abbreviations used: ICH: International Council for Harmonisation, DMF: Drug master
file, CMC: Chemistry, manufacturing, controls
3-15 years for 1 drug approval
Approved drug
FDA approval
Post marketing
surveillance
T= 0
1-6 years
2-7 years
0.5-2 years
Drug discovery
Preclinical
Clinical
trials
Drug discovery
Clinical
trials
33
34. Characteristics of the right partner
Partners play a big role
1
3
2
High quality products
High and consistent quality GMP
raw materials
Formulation services
Deep knowhow
Deep knowledge in:
• Raw material and LNP
manufacturing, analytics
• Regulatory landscape, dossier
preparation
Right facilities
Appropriate quality systems: Manufacturing under ICH Q7
Excellent audit track record
Consistent supply
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 202034
35. Points to consider and risk mitigation strategies
Appropriate number of suppliers
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 2020
✓ Find a supplier who can manufacture out of 2
sites using same process and analytical methods
✓ 3-5 year supply agreements
✓ Establish safety stocks
✓ Maintain a quality agreement
2 or more sources
for each raw material?
Pros: Security of supply
Cons:
• Management of multiple suppliers is time and cost consuming
• Higher regulatory workload
• Additional documents required, e.g. multiple CMC sections
• Detailed description of differences
• Show equivalency of performance
• Increased risk of regulatory hurdles
Risk mitigation
strategies :
1 source/ raw material
35
37. + + +=
Special lipid Helper lipids
Custom
manufacturing
Lipid Portfolio
✓ Ionizable lipids
✓ PEG lipids
✓ Targeted lipids
✓ Synthetic origin lipids
✓ Broad portfolio
✓ Customized pack sizes
Fully Support lipid based drug delivery
Product
Development
Preclinical
Collaboration, Innovation, Speed
Development
(Clinical Phases)
On-Time, Scale-Up, Flexibility
Commercial
Consistency – Regulatory - Cost
High
frequented
inspected
sites
CoE & world
leading Supplier
for lipids
All competence on
site with strong
connection to global
expertise
Strong team with
85+ years of
combined
experience
Technical,
analytical,
regulatory
support
38. Agenda
1. Introduction
RNA therapeutics, Comparison of different RNA drug delivery systems
2. Critical parameters defining activity of lipid-based formulations
Composition, source, quality, formulation process
3. Essential considerations for successful drug development
Timing, regulatory aspects, number of sources, supplier choice
4. Summary and Q&A
39. Quality → performance
Summary
1
Plan ahead
Intelligent
formulation design,
Choice of lipids,
source, formulation
process
2
3 Right partners
Reduce cost of drug
development, and
boost success
4
Plug and play
Encapsulation
systems for RNA
therapeutics and
vaccines
Successful development for lipid based RNA delivery and vaccines, Shiksha Mantri, 202039
Ensure quality
Inconsistent quality=
irreproducible results,
regulatory hurdles, high
costs, Wasted resources