This document discusses using a high seed fed-batch (HSFB) process compared to a standard fed-batch process for monoclonal antibody production. It presents results from experiments conducted using 3L bioreactors. The HSFB process uses an inoculation density of 5x106 cells/mL compared to 0.5x106 cells/mL for the standard process. The HSFB process achieved a titer increase within the variability range and reached that titer 3 days earlier than the standard process. Other metrics like viable cell density, viability, specific productivity, and metabolite levels were also compared between the two processes. The results suggest the HSFB process can accelerate production timelines while maintaining comparable product quality.
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMilliporeSigma
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.emdmillipore.com/webinars
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...Merck Life Sciences
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
Process Intensification for future bioprocessingMilliporeSigma
Watch the interactive recording here: https://bit.ly/2OdLYwX
Process optimization and upstream intensification led to smaller, more efficient biomanufacturing facilities becoming more commonplace, with smaller facilities comprised primarily of single use or hybrid technology capable of producing significant amounts of drug product. Such changes, however, bring new challenges, like managing the supply of huge amounts of cell culture media or buffers within smaller footprints. In this webinar two topics will be addressed that help to intensify upstream and downstream processes and address the challenges of future facilities.
Bulk powders of cell culture media (CCM) or single chemicals often show physical disadvantages. CCM powders with fine particles show high dust formation and poor flowability. In addition, dissolution is time consuming due to floating of light particles on the water surface. For the pursued intensification of upstream processing, media preparation times are becoming a serious bottleneck. This mainly accounts for the much higher media consumption or higher concentrated media formulations for future continuous upstream processes. Granulated material can overcome limitations with CCM powder, while additionally being a viable option to reduce caking of bulk chemicals like buffers.
Buffer production for downstream processing remains a significant portion of the facility footprint, labor needs and equipment cost. As downstream operations are essentially product-mass-based, increased productivity in upstream will lead to a proportional increase in demand for downstream buffers. Merck KGaA Darmstadt, Germanty R&D has their expertise in concentration of buffers to improve and streamline buffer management.
Media and Process Development for Seed Train IntensificationMilliporeSigma
Access the interactive recording here: https://bit.ly/35UCJWg
Abstract:
Media composition plays a critical role for biopharmaceutical production as well as seed train expansion. The right combination of media, specifically designed for their purposes, in a seed train including a perfused N-1 step, can increase productivity in the final perfused production step. This indicates that specific companion media combinations can increase productivity gains with these intensified process formats. Using this technology combined with high cell density cryopreservation serves as an ideal possibility to intensify upstream processing.
In this webinar, you will learn:
- Introduction to intensified upstream processing
- How combining media, specifically designed for seed train, production and harvest intensification, can increase the cell specific productivity (Qp) in the final production stage
- How applying high cell density cryopreservation can significantly shorten your seed train
Accelerating cell therapy manufacturing through robust process development - ...MilliporeSigma
Watch the webinar here: https://bit.ly/2WFoinn
Industry trends in regenerative medicine highlight a critical need for automated and closed manufacturing to support scalable production. With over 1,000 clinical trials underway worldwide utilizing the RM/AT designation, it's increasingly more important that successful clinical trials translate to marketable treatments. To ensure proper translation, manufacturing strategies must generate products that are effective, safe, consistent and help reduce costs. To achieve this goal, fit-for-purpose solutions are required.
This webinar presents an introduction to our fit-for-purpose cell therapy manufacturing solution, the ekko™ cell processing system. We will share process development strategies through case studies that support a variety of unit operation steps across cell types, including but not limited to, wash and concentration of T cells and aggregate processing of induced pluripotent cells.
The goal of our presentation is to share process development strategies for solutions that can be seamlessly translated and implemented for use in commercial production.
In this webinar, you will learn:
* Manufacturing trends for closed and automated cell therapy processes and requirements for industrialization of cell therapies
* Introduction to acoustic cell processing and how it works
* Process optimization with case studies across a variety of cell types and unit operations
Solubility Enhancement, Stability and Scalability of Mesoporous Silica Formul...MilliporeSigma
In these slides, you will be introduced to the science and scale-up behind mesoporous silica technology, an emerging formulation option for poorly soluble drug delivery.
Included in the slides:
- A broad overview of mesoporous silica technology
- An introduction to the unique stability advantages of mesoporous silica
- Case studies of in vitro and in vivo performance of mesoporous silica formulations
- How to scale-up from lab to production scale
Watch the webinar here: https://bit.ly/2IoV8k7
A Cost Analysis and Evaluation of Perfused Seed Train Scenarios Through Proce...MilliporeSigma
Access the interactive recording: https://bit.ly/386d4fh
Abstract:
The bioprocessing industry is driving towards intensified processes to reduce cost of goods and/or increase productivity. Perfused seed is one specific intensified upstream process that can provide benefits to mAb production. To better understand these benefits, BioSolve process modeling software was used to perform a holistic cost analysis of several different perfused seed train scenarios. The effect of variables such as production/seed ratio, number of production bioreactors, titer, and production duration were evaluated. Results showed that under certain scenarios, perfused seed train options could deliver lower cost of goods, increase product throughput, or a combination of both.
Hot melt extrusion with PVA: A new opportunity for challenging APIs Merck Life Sciences
Access the interactive recording: https://bit.ly/2PSxDUj
Abstract:
Hot melt extrusion is considered to be one of the most effective technology for the creation of solid dispersion. Its rapid advancement in the development of new pharmaceutical products highlights its importance.
In this webinar you will learn about the potential of hot melt extrusion technology to overcome challenges in solubility and bioavailability of drug substances by using polyvinyl alcohol (PVA) as a matrix polymer.
We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as an overview of actual formulation trends.
You will gain insights in novel screening tools for hot melt extrusion which can represent a decisive strategic advantage at early development stages. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release.
Another aspect involves the versatile down-stream options to create your final dosage form as well as innovative applications.
In this webinar, you will learn:
* about amorphous solid dispersions and their preparation by hot melt extrusion
* how to identify the right polymer at early development stages
* how to improve the performance of your formulation by using polyvinyl alcohol
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMilliporeSigma
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.emdmillipore.com/webinars
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...Merck Life Sciences
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
Process Intensification for future bioprocessingMilliporeSigma
Watch the interactive recording here: https://bit.ly/2OdLYwX
Process optimization and upstream intensification led to smaller, more efficient biomanufacturing facilities becoming more commonplace, with smaller facilities comprised primarily of single use or hybrid technology capable of producing significant amounts of drug product. Such changes, however, bring new challenges, like managing the supply of huge amounts of cell culture media or buffers within smaller footprints. In this webinar two topics will be addressed that help to intensify upstream and downstream processes and address the challenges of future facilities.
Bulk powders of cell culture media (CCM) or single chemicals often show physical disadvantages. CCM powders with fine particles show high dust formation and poor flowability. In addition, dissolution is time consuming due to floating of light particles on the water surface. For the pursued intensification of upstream processing, media preparation times are becoming a serious bottleneck. This mainly accounts for the much higher media consumption or higher concentrated media formulations for future continuous upstream processes. Granulated material can overcome limitations with CCM powder, while additionally being a viable option to reduce caking of bulk chemicals like buffers.
Buffer production for downstream processing remains a significant portion of the facility footprint, labor needs and equipment cost. As downstream operations are essentially product-mass-based, increased productivity in upstream will lead to a proportional increase in demand for downstream buffers. Merck KGaA Darmstadt, Germanty R&D has their expertise in concentration of buffers to improve and streamline buffer management.
Media and Process Development for Seed Train IntensificationMilliporeSigma
Access the interactive recording here: https://bit.ly/35UCJWg
Abstract:
Media composition plays a critical role for biopharmaceutical production as well as seed train expansion. The right combination of media, specifically designed for their purposes, in a seed train including a perfused N-1 step, can increase productivity in the final perfused production step. This indicates that specific companion media combinations can increase productivity gains with these intensified process formats. Using this technology combined with high cell density cryopreservation serves as an ideal possibility to intensify upstream processing.
In this webinar, you will learn:
- Introduction to intensified upstream processing
- How combining media, specifically designed for seed train, production and harvest intensification, can increase the cell specific productivity (Qp) in the final production stage
- How applying high cell density cryopreservation can significantly shorten your seed train
Accelerating cell therapy manufacturing through robust process development - ...MilliporeSigma
Watch the webinar here: https://bit.ly/2WFoinn
Industry trends in regenerative medicine highlight a critical need for automated and closed manufacturing to support scalable production. With over 1,000 clinical trials underway worldwide utilizing the RM/AT designation, it's increasingly more important that successful clinical trials translate to marketable treatments. To ensure proper translation, manufacturing strategies must generate products that are effective, safe, consistent and help reduce costs. To achieve this goal, fit-for-purpose solutions are required.
This webinar presents an introduction to our fit-for-purpose cell therapy manufacturing solution, the ekko™ cell processing system. We will share process development strategies through case studies that support a variety of unit operation steps across cell types, including but not limited to, wash and concentration of T cells and aggregate processing of induced pluripotent cells.
The goal of our presentation is to share process development strategies for solutions that can be seamlessly translated and implemented for use in commercial production.
In this webinar, you will learn:
* Manufacturing trends for closed and automated cell therapy processes and requirements for industrialization of cell therapies
* Introduction to acoustic cell processing and how it works
* Process optimization with case studies across a variety of cell types and unit operations
Solubility Enhancement, Stability and Scalability of Mesoporous Silica Formul...MilliporeSigma
In these slides, you will be introduced to the science and scale-up behind mesoporous silica technology, an emerging formulation option for poorly soluble drug delivery.
Included in the slides:
- A broad overview of mesoporous silica technology
- An introduction to the unique stability advantages of mesoporous silica
- Case studies of in vitro and in vivo performance of mesoporous silica formulations
- How to scale-up from lab to production scale
Watch the webinar here: https://bit.ly/2IoV8k7
A Cost Analysis and Evaluation of Perfused Seed Train Scenarios Through Proce...MilliporeSigma
Access the interactive recording: https://bit.ly/386d4fh
Abstract:
The bioprocessing industry is driving towards intensified processes to reduce cost of goods and/or increase productivity. Perfused seed is one specific intensified upstream process that can provide benefits to mAb production. To better understand these benefits, BioSolve process modeling software was used to perform a holistic cost analysis of several different perfused seed train scenarios. The effect of variables such as production/seed ratio, number of production bioreactors, titer, and production duration were evaluated. Results showed that under certain scenarios, perfused seed train options could deliver lower cost of goods, increase product throughput, or a combination of both.
Hot melt extrusion with PVA: A new opportunity for challenging APIs Merck Life Sciences
Access the interactive recording: https://bit.ly/2PSxDUj
Abstract:
Hot melt extrusion is considered to be one of the most effective technology for the creation of solid dispersion. Its rapid advancement in the development of new pharmaceutical products highlights its importance.
In this webinar you will learn about the potential of hot melt extrusion technology to overcome challenges in solubility and bioavailability of drug substances by using polyvinyl alcohol (PVA) as a matrix polymer.
We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as an overview of actual formulation trends.
You will gain insights in novel screening tools for hot melt extrusion which can represent a decisive strategic advantage at early development stages. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release.
Another aspect involves the versatile down-stream options to create your final dosage form as well as innovative applications.
In this webinar, you will learn:
* about amorphous solid dispersions and their preparation by hot melt extrusion
* how to identify the right polymer at early development stages
* how to improve the performance of your formulation by using polyvinyl alcohol
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
Investing in Process Development for Increased MSC Production in Stirred Tank...MilliporeSigma
Interested in developing a robust cell therapy manufacturing platform? In this webinar we will share information in the form of case studies that highlight strategies to optimize your cell therapy production process.
Industry trends in regenerative medicine highlight a critical need for closed cell culture systems that support scalable manufacturing of adherent cell therapies. Typical static in vitro culture methods, however, are often too cumbersome and inefficient to support commercial scale production of mesenchymal stem/stromal cells (MSCs). Single-use stirred tank bioreactor systems are a platform that can address this limitation and have been proven effective for microcarrier-based production of adherent cell therapies. Implementation of optimized process control strategies for parameters such as dissolved oxygen (DO) and agitation rate are key to making an efficient transition from planar culture to stirred tank bioreactors. Herein, a stepwise approach to process development for MSC expansion in a small-scale single-use bioreactor is presented. Case studies focus on strategies to optimize DO control and agitation rates for bone marrow derived MSCs in microcarrier culture, highlighting improvements in process efficiency. In the first case study, the impact different gassing methods have on DO control and whether hypoxic growth conditions affect MSC function are examined. The second case study demonstrates the application of Zwietering’s equation for suspension of solids to overcome scaling challenges often associated with microcarrier culture in stirred tanks. Strategies to further improve the seeding process for bioreactor culture will also be reviewed. Identifying optimal seeding and process control strategies for microcarrier-based bioreactor expansion of adherent cells is paramount for the development of robust cell therapy manufacturing platforms.
In this webinar, you will learn about:
· Process development approaches for production scale-up of mesenchymal stem cells (MSCs)
· Implementing single-use, closed systems for manufacturing cell therapies
· Case studies focusing on strategies to optimize DO control and agitation rates for microcarrier-based cultures
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
Exploring Intensified Seed Train Through Advancements in Perfusion Processing...Merck Life Sciences
This poster explores key elements of bioreactor design and automation strategies that enable successful implementation of seed train intensification via perfusion:
- Sparger performance characterization
- Cell retention device connection
- Evaluation of the Hamiltion® Incyte viable cell density (or permittivity) sensor
- Cell culture case studies
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.merckmillipore.com/mlab
Long Acting Injectables - A New Dimension for Proteins and PeptidesMerck Life Sciences
Access the recording: https://bit.ly/2xAaMba
Abstract:
Long acting injectables (LAI) have been around for decades for the delivery of small molecules and peptides to treat chronic and site-specific diseases. However, when it comes to more sensitive biological therapeutics the classical polylactide and polylactide/glycolide based systems suffer from several limitations (e.g. uncontrolled release kinetics, in situ pH drop, protein degradation) making them unsuitable. The SynBiosys® biodegradable polymeric microparticle technology combines all the features required for LAI formulations for biologics. In two case studies we will showcase sustained release formulations for peptides and proteins and demonstrate their potential via extensive in vitro and in vivo characterization.
Driving Value in the Evolution Toward Continuous Monoclonal Antibody ProcessingMilliporeSigma
With intensification of upstream and downstream processes, several scenarios for mAb production become apparent. We will identify these scenarios with process modeling data to quantify the financial benefits and holistic value of these technologies.
The biopharmaceutical industry is adopting a more strategic view toward monoclonal antibody manufacturing. There is a drive to develop processes with higher productivity and improved economics without sacrificing robustness or quality. Initiatives to achieve these goals through unit operation intensification, connected processing, and continuous processing have been a major focus and this trend will only accelerate.
Opportunities for process intensification exist throughout the entire monoclonal antibody process. With the implementation of perfusion-based operations from seed train to production bioreactors, and downstream technologies such as intensified capture chromatography, in-line virus inactivation, and flow-through polishing, a variety of scenarios for Mab production trains become apparent. In this presentation, we will identify several of these production scenarios with process modeling data to quantify the financial benefits and holistic value derived from the integration and intensification of Mab processes.
In this webinar, you will learn:
- The technologies being evaluated for upstream and downstream process intensification.
- Options for integration of these technologies for Mab production.
- Process and cost modeling for several process scenarios using intensification, connected, and continuous operations.
Watch the presentation of this webinar here: https://bit.ly/3ELoVzo
Understanding how your mAb behaves under various conditions is a crucial part of product characterization and quality assurance programs. Join this panel-style webinar to gain insights into key aspects of stability testing, from regulatory expectations to timeline and design considerations.
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.
In this webinar, you will learn:
• Key considerations on when and how to effectively plan your stability testing program
• How to ensure the right selection of assays for your testing package
• How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Presented by:
Greg Pirozzi, Ph.D.
Senior Project Manager, Custom Projects
Pamela Hamill, Ph.D.
Technical Consultant, Field Technology Management
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Implementing a Fully Single-Use, Integrated mAb Biosimilars Purification Plat...MilliporeSigma
Access the interactive recording here: https://bit.ly/2DONZaQ
Webinar summary:
1000L-scale implementation of fully connected, disposable, advanced DSP platform for next generation mAb production.
Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest.
Next Generation Biopharmaceutical Downstream Process is a European-funded collaborative project that aims at implementing a fully integrated manufacturing platform for biosimilar mAb based on continuous chromatography, in combination with single-use disposable technologies for all unit operations of DSP on pilot/small production scale together with incorporation of advanced analytical tools.
In this webinar, you will see:
* new DSP purification template producing > 3.3 kg of mAb in 2.5 days in less than 30m²
* proof of concept for the mAb manufacturing of tomorrow
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Facility Intensification and Cost Reduction using an Integrated Buffer Delive...Merck Life Sciences
Access the interactive recording: https://bit.ly/35vWeoD
Abstract:
Downstream processing of monoclonal antibodies and other recombinant proteins requires large volumes of buffer to maintain pH and conductivity during chromatographic and ultrafiltration operations. A typical process requires more than 5 L of buffer in downstream purification operations for each liter of cell culture processed. The preparation of these buffers requires a large footprint for ‘buffer farms’ with mixing tanks, filtration equipment and storage tanks to meet the continuous demand for buffers for an overall facility. This has been cited as a bottleneck by many manufacturing facilities.
The ability to outsource or implement a streamlined buffer preparation step has numerous benefits including reduced capital, labor, floor space, raw materials inventory, facility overhead and QC testing and release. With these benefits come some risks that pharmaceutical manufacturers must address before implementing a new buffer preparation strategy for these critical raw materials that are fundamental to manufacturing. These risks include raw material variability, accuracy of the buffer specifications, as well as stability and quality of the buffer upon transport and over time.
In this webinar, you will learn:
- How to implement and benefit from an integrated buffer delivery platform
- How to ensure quality and accuracy of the buffers using risk-mitigation and cost modelling
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
Scaling Strategies with Stirred Single-Use Bioreactors from Bench to Clinical...Merck Life Sciences
This presentation introduces the general principles of scaling strategies with stirred single-use bioreactors, discusses key engineering parameters, and concludes with a case study of how these strategies are applied to Mobius® bioreactors from 2 liters to 2000 liters.
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.merckmillipore.com/mlab
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMerck Life Sciences
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.merckmillipore.com/webinars
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.emdmillipore.com/webinars
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...Merck Life Sciences
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.merckmillipore.com/webinars
Media and Process Development for Seed Train IntensificationMerck Life Sciences
Access the interactive recording: https://bit.ly/35UCJWg
Abstract:
Media composition plays a critical role for biopharmaceutical production as well as seed train expansion. The right combination of media, specifically designed for their purposes, in a seed train including a perfused N-1 step, can increase productivity in the final perfused production step. This indicates that specific companion media combinations can increase productivity gains with these intensified process formats. Using this technology combined with high cell density cryopreservation serves as an ideal possibility to intensify upstream processing.
In this webinar, you will learn:
- Introduction to intensified upstream processing
- How combining media, specifically designed for seed train, production and harvest intensification, can increase the cell specific productivity (Qp) in the final production stage
- How applying high cell density cryopreservation can significantly shorten your seed train
A Cost Analysis and Evaluation of Perfused Seed Train Scenarios Through Proce...Merck Life Sciences
Access the interactive recording: https://bit.ly/386d4fh
Abstract:
The bioprocessing industry is driving towards intensified processes to reduce cost of goods and/or increase productivity. Perfused seed is one specific intensified upstream process that can provide benefits to mAb production. To better understand these benefits, BioSolve process modeling software was used to perform a holistic cost analysis of several different perfused seed train scenarios. The effect of variables such as production/seed ratio, number of production bioreactors, titer, and production duration were evaluated. Results showed that under certain scenarios, perfused seed train options could deliver lower cost of goods, increase product throughput, or a combination of both.
Driving Value in the Evolution Toward Continuous Monoclonal Antibody ProcessingMerck Life Sciences
With intensification of upstream and downstream processes, several scenarios for mAb production become apparent. We will identify these scenarios with process modeling data to quantify the financial benefits and holistic value of these technologies.
The biopharmaceutical industry is adopting a more strategic view toward monoclonal antibody manufacturing. There is a drive to develop processes with higher productivity and improved economics without sacrificing robustness or quality. Initiatives to achieve these goals through unit operation intensification, connected processing, and continuous processing have been a major focus and this trend will only accelerate.
Opportunities for process intensification exist throughout the entire monoclonal antibody process. With the implementation of perfusion-based operations from seed train to production bioreactors, and downstream technologies such as intensified capture chromatography, in-line virus inactivation, and flow-through polishing, a variety of scenarios for Mab production trains become apparent. In this presentation, we will identify several of these production scenarios with process modeling data to quantify the financial benefits and holistic value derived from the integration and intensification of Mab processes.
In this webinar, you will learn:
- The technologies being evaluated for upstream and downstream process intensification.
- Options for integration of these technologies for Mab production.
- Process and cost modeling for several process scenarios using intensification, connected, and continuous operations.
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
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
Investing in Process Development for Increased MSC Production in Stirred Tank...MilliporeSigma
Interested in developing a robust cell therapy manufacturing platform? In this webinar we will share information in the form of case studies that highlight strategies to optimize your cell therapy production process.
Industry trends in regenerative medicine highlight a critical need for closed cell culture systems that support scalable manufacturing of adherent cell therapies. Typical static in vitro culture methods, however, are often too cumbersome and inefficient to support commercial scale production of mesenchymal stem/stromal cells (MSCs). Single-use stirred tank bioreactor systems are a platform that can address this limitation and have been proven effective for microcarrier-based production of adherent cell therapies. Implementation of optimized process control strategies for parameters such as dissolved oxygen (DO) and agitation rate are key to making an efficient transition from planar culture to stirred tank bioreactors. Herein, a stepwise approach to process development for MSC expansion in a small-scale single-use bioreactor is presented. Case studies focus on strategies to optimize DO control and agitation rates for bone marrow derived MSCs in microcarrier culture, highlighting improvements in process efficiency. In the first case study, the impact different gassing methods have on DO control and whether hypoxic growth conditions affect MSC function are examined. The second case study demonstrates the application of Zwietering’s equation for suspension of solids to overcome scaling challenges often associated with microcarrier culture in stirred tanks. Strategies to further improve the seeding process for bioreactor culture will also be reviewed. Identifying optimal seeding and process control strategies for microcarrier-based bioreactor expansion of adherent cells is paramount for the development of robust cell therapy manufacturing platforms.
In this webinar, you will learn about:
· Process development approaches for production scale-up of mesenchymal stem cells (MSCs)
· Implementing single-use, closed systems for manufacturing cell therapies
· Case studies focusing on strategies to optimize DO control and agitation rates for microcarrier-based cultures
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
Exploring Intensified Seed Train Through Advancements in Perfusion Processing...Merck Life Sciences
This poster explores key elements of bioreactor design and automation strategies that enable successful implementation of seed train intensification via perfusion:
- Sparger performance characterization
- Cell retention device connection
- Evaluation of the Hamiltion® Incyte viable cell density (or permittivity) sensor
- Cell culture case studies
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.merckmillipore.com/mlab
Long Acting Injectables - A New Dimension for Proteins and PeptidesMerck Life Sciences
Access the recording: https://bit.ly/2xAaMba
Abstract:
Long acting injectables (LAI) have been around for decades for the delivery of small molecules and peptides to treat chronic and site-specific diseases. However, when it comes to more sensitive biological therapeutics the classical polylactide and polylactide/glycolide based systems suffer from several limitations (e.g. uncontrolled release kinetics, in situ pH drop, protein degradation) making them unsuitable. The SynBiosys® biodegradable polymeric microparticle technology combines all the features required for LAI formulations for biologics. In two case studies we will showcase sustained release formulations for peptides and proteins and demonstrate their potential via extensive in vitro and in vivo characterization.
Driving Value in the Evolution Toward Continuous Monoclonal Antibody ProcessingMilliporeSigma
With intensification of upstream and downstream processes, several scenarios for mAb production become apparent. We will identify these scenarios with process modeling data to quantify the financial benefits and holistic value of these technologies.
The biopharmaceutical industry is adopting a more strategic view toward monoclonal antibody manufacturing. There is a drive to develop processes with higher productivity and improved economics without sacrificing robustness or quality. Initiatives to achieve these goals through unit operation intensification, connected processing, and continuous processing have been a major focus and this trend will only accelerate.
Opportunities for process intensification exist throughout the entire monoclonal antibody process. With the implementation of perfusion-based operations from seed train to production bioreactors, and downstream technologies such as intensified capture chromatography, in-line virus inactivation, and flow-through polishing, a variety of scenarios for Mab production trains become apparent. In this presentation, we will identify several of these production scenarios with process modeling data to quantify the financial benefits and holistic value derived from the integration and intensification of Mab processes.
In this webinar, you will learn:
- The technologies being evaluated for upstream and downstream process intensification.
- Options for integration of these technologies for Mab production.
- Process and cost modeling for several process scenarios using intensification, connected, and continuous operations.
Watch the presentation of this webinar here: https://bit.ly/3ELoVzo
Understanding how your mAb behaves under various conditions is a crucial part of product characterization and quality assurance programs. Join this panel-style webinar to gain insights into key aspects of stability testing, from regulatory expectations to timeline and design considerations.
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.
Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.
Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.
In this webinar, you will learn:
• Key considerations on when and how to effectively plan your stability testing program
• How to ensure the right selection of assays for your testing package
• How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Presented by:
Greg Pirozzi, Ph.D.
Senior Project Manager, Custom Projects
Pamela Hamill, Ph.D.
Technical Consultant, Field Technology Management
Watch the interactive recording here: https://bit.ly/30FTDG0
The quest for a viable upstream process relies on generation of a cell line expressing the protein of interest. Unfortunately, the search for the best-producing clone is often compared with looking for a needle in a haystack. Making this more challenging is the pressure to get it right the first time, quickly and while mitigating risk and costs.
Although a lot of efforts are made on the clonal selection, there is often few to none optimization done on the expression cassette, including promoter and enhancer selection, or signal peptide. The statistical approach on how many clones should be screened to get to a good producer is often overlooked as well.
We combined a new generation of promoters and enhancers to improve strategies on pool and mini pool screening with both CHO-K1 and our own CHOZN® GS which helped deliver high-producing clones in an accelerated timeline. In addition, we are able to begin process development in parallel with cell line development, further reducing timelines.
In this webinar, you will learn:
* How the strategy approach can help reducing the overall timeline of cell line generation
* How we have expanded our platform by designing a completely new vector/cell/process template
* How we have worked on promoters, enhancers, pool/mini-pool approach as well as on timelines from DNA to clone
Implementing a Fully Single-Use, Integrated mAb Biosimilars Purification Plat...MilliporeSigma
Access the interactive recording here: https://bit.ly/2DONZaQ
Webinar summary:
1000L-scale implementation of fully connected, disposable, advanced DSP platform for next generation mAb production.
Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest.
Next Generation Biopharmaceutical Downstream Process is a European-funded collaborative project that aims at implementing a fully integrated manufacturing platform for biosimilar mAb based on continuous chromatography, in combination with single-use disposable technologies for all unit operations of DSP on pilot/small production scale together with incorporation of advanced analytical tools.
In this webinar, you will see:
* new DSP purification template producing > 3.3 kg of mAb in 2.5 days in less than 30m²
* proof of concept for the mAb manufacturing of tomorrow
Addressing the Challenge of Scalability in Viral VectorsMilliporeSigma
Watch this webinar here: https://bit.ly/3jlcEXH
Addressing the Challenge of Scalability in Viral Vectors
To meet the ever-increasing demands for cell and gene therapies, there is a need to shift away from expensive, labor-intensive cell culture and scale up systems. But this goal cannot be met without a robust production strategy based on clinical indication, population size and dosing requirements.
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs based on clinical indication, population size and dosing requirements. Most production processes today rely on labor-intensive and expensive adherent cell culture systems and scale out approaches. This webinar will highlight the importance of a scalable process that supports clinical through commercial needs. We will introduce a suspension-based process we have developed, including a HEK 293T cell line, chemically defined media, and optimized process conditions that results in higher yield, easier scalability, and lower production costs.
In this webinar, you will learn:
• Why suspension cell based processes are easier, faster, and more economical than adherent cell growth cultures
• Use of chemically defined medium for improved cellular growth, viral productivity, easier downstream purification and improved safety from adventitious agents
• Unraveling the complexities of the HEK293 and 293T cell lines
• The importance of planning for scalability and manufacturability from the earliest stages of process development
• How a scalable templated process can reduce time needed to move from product development to commercialization
Facility Intensification and Cost Reduction using an Integrated Buffer Delive...Merck Life Sciences
Access the interactive recording: https://bit.ly/35vWeoD
Abstract:
Downstream processing of monoclonal antibodies and other recombinant proteins requires large volumes of buffer to maintain pH and conductivity during chromatographic and ultrafiltration operations. A typical process requires more than 5 L of buffer in downstream purification operations for each liter of cell culture processed. The preparation of these buffers requires a large footprint for ‘buffer farms’ with mixing tanks, filtration equipment and storage tanks to meet the continuous demand for buffers for an overall facility. This has been cited as a bottleneck by many manufacturing facilities.
The ability to outsource or implement a streamlined buffer preparation step has numerous benefits including reduced capital, labor, floor space, raw materials inventory, facility overhead and QC testing and release. With these benefits come some risks that pharmaceutical manufacturers must address before implementing a new buffer preparation strategy for these critical raw materials that are fundamental to manufacturing. These risks include raw material variability, accuracy of the buffer specifications, as well as stability and quality of the buffer upon transport and over time.
In this webinar, you will learn:
- How to implement and benefit from an integrated buffer delivery platform
- How to ensure quality and accuracy of the buffers using risk-mitigation and cost modelling
Streamlining Biopharmaceutical Cell Line Development - Reducing risk and decr...Merck Life Sciences
CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. This webinar will educate the audience about challenges faced with traditional expression systems and how the CHO cell line with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefits for fast and efficient cell line development as well as stable and high titer expression. We will explore additional cell line engineering targets that can be modified to engineer a cell line that mitigates risks and removes bottlenecks throughout the biopharmaceutical process.
In this webinar, you will learn:
• What are the benefits of using an optimized/engineered expression system?
• What can be done throughout the cell line development process to mitigate risks and remove bottlenecks?
• Applications of cell line engineering for further upstream biopharmaceutical enhancements.
Scaling Strategies with Stirred Single-Use Bioreactors from Bench to Clinical...Merck Life Sciences
This presentation introduces the general principles of scaling strategies with stirred single-use bioreactors, discusses key engineering parameters, and concludes with a case study of how these strategies are applied to Mobius® bioreactors from 2 liters to 2000 liters.
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.merckmillipore.com/mlab
Webinar: Novel Perfusion Filter and Controller for N-1 ApplicationMerck Life Sciences
Participate in the interactive webinar now: http://bit.ly/SeedTrainPt2
The industry focus on process intensification is driving an increase in adoption of perfusion within the seed train. In an effort to deliver on the need for a robust solution we have developed a filter/controller duo that makes process intensification a reality!
Explore our webinar library: www.merckmillipore.com/webinars
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.emdmillipore.com/webinars
Straight to the Point: Reaching Clinical Stage Development with a CHOZN® Cell...Merck Life Sciences
Participate in the interactive webinar: http://bit.ly/CHOZNWebinar
In this case study, we will present how we support our clients thanks to advantages provided by the CHOZN® Cell Line, and a specific strategy for clone selection where semi-automation and pool selection are leveraged, to get upstream right first time.
Explore our webinar library: www.merckmillipore.com/webinars
Media and Process Development for Seed Train IntensificationMerck Life Sciences
Access the interactive recording: https://bit.ly/35UCJWg
Abstract:
Media composition plays a critical role for biopharmaceutical production as well as seed train expansion. The right combination of media, specifically designed for their purposes, in a seed train including a perfused N-1 step, can increase productivity in the final perfused production step. This indicates that specific companion media combinations can increase productivity gains with these intensified process formats. Using this technology combined with high cell density cryopreservation serves as an ideal possibility to intensify upstream processing.
In this webinar, you will learn:
- Introduction to intensified upstream processing
- How combining media, specifically designed for seed train, production and harvest intensification, can increase the cell specific productivity (Qp) in the final production stage
- How applying high cell density cryopreservation can significantly shorten your seed train
A Cost Analysis and Evaluation of Perfused Seed Train Scenarios Through Proce...Merck Life Sciences
Access the interactive recording: https://bit.ly/386d4fh
Abstract:
The bioprocessing industry is driving towards intensified processes to reduce cost of goods and/or increase productivity. Perfused seed is one specific intensified upstream process that can provide benefits to mAb production. To better understand these benefits, BioSolve process modeling software was used to perform a holistic cost analysis of several different perfused seed train scenarios. The effect of variables such as production/seed ratio, number of production bioreactors, titer, and production duration were evaluated. Results showed that under certain scenarios, perfused seed train options could deliver lower cost of goods, increase product throughput, or a combination of both.
Driving Value in the Evolution Toward Continuous Monoclonal Antibody ProcessingMerck Life Sciences
With intensification of upstream and downstream processes, several scenarios for mAb production become apparent. We will identify these scenarios with process modeling data to quantify the financial benefits and holistic value of these technologies.
The biopharmaceutical industry is adopting a more strategic view toward monoclonal antibody manufacturing. There is a drive to develop processes with higher productivity and improved economics without sacrificing robustness or quality. Initiatives to achieve these goals through unit operation intensification, connected processing, and continuous processing have been a major focus and this trend will only accelerate.
Opportunities for process intensification exist throughout the entire monoclonal antibody process. With the implementation of perfusion-based operations from seed train to production bioreactors, and downstream technologies such as intensified capture chromatography, in-line virus inactivation, and flow-through polishing, a variety of scenarios for Mab production trains become apparent. In this presentation, we will identify several of these production scenarios with process modeling data to quantify the financial benefits and holistic value derived from the integration and intensification of Mab processes.
In this webinar, you will learn:
- The technologies being evaluated for upstream and downstream process intensification.
- Options for integration of these technologies for Mab production.
- Process and cost modeling for several process scenarios using intensification, connected, and continuous operations.
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...MilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
The demand for the fast and robust development of manufacturing cell lines is ever growing, with an increasing number of therapeutic proteins in development. To fulfill these needs, Celonic engineered the cell line kit CHOvolution™, which equips users with everything required for the development of mammalian cell lines and provides an integrated support system for assistance.
High Productivity Membrane Chromatography: Enabling the Next Generation Biopr...MilliporeSigma
A novel single-use chromatography platform enabling cost-efficient manufacturing to support the growing global demand for affordable biologics.
A new single-use (per batch) chromatography platform employs traditional, proven chemistries in an inventive hydrogel polymer membrane format that enables the next generation bioprocessing paradigm. The experimental Protein A membrane, featuring a 10-fold improvement in productivity over resin columns and high selectivity (i.e. 3 LRV HCP), is combined with high performance membranes with mixed mode and ion exchange modalities for a fully single-use membrane-based purification process. The membrane columns show protein capacities similar or superior to reference resins in bind and elute, and up to 7 LRV clearance of MVM at 20kg/L in flow through mode. A membrane-based process allows a holistic process strategy involving small footprint, high throughput processing by means of a rapid multi-cycling capture step (up to 100 cycles per batch) and high capacity flow through polishing. This single-use (per batch) platform results in simple, compact, flexible, yet robust and safe downstream operations for cost-efficient manufacturing to support the growing demand for affordable biologics.
In this webinar, you will learn about:
• Advantages of a fully single-use membrane-based purification processes
• High capacity flow through polishing with an inventive membrane adsorber combining the best of resins (DBC) and membranes (30x of flow rate)
Yaohai Bio-Pharma is the first and the largest biologics CRTDMO (Contract Research, Testing, Development and Manufacturing Organization) focusing on microbial expression system in China, which was established in China Medical City, Taizhou with a 20, 000 square meters plant.
As a one-stop biologics CRTDMO, Yaohai provide customized end-to-end solutions from DNA to drug substance manufacturing and product fill & finish across diversified modalities, such as recombinant proteins, peptides and polypeptides, enzymes, antibody fragments and nano-antibodies, plasmid DNA and mRNA, Glyco-polymers, virus-like particle (VLP), to meet global customers’ clinical and commercial needs in biological drugs, biosimilars, vaccines and diagnostics for human and veterinary use.
https://www.yaohai-bio.com.cn/downloadfile
Investing in Process Development for Increased MSC Production in Stirred Tank...Merck Life Sciences
Interested in developing a robust cell therapy manufacturing platform? In this webinar we will share information in the form of case studies that highlight strategies to optimize your cell therapy production process.
Industry trends in regenerative medicine highlight a critical need for closed cell culture systems that support scalable manufacturing of adherent cell therapies. Typical static in vitro culture methods, however, are often too cumbersome and inefficient to support commercial scale production of mesenchymal stem/stromal cells (MSCs). Single-use stirred tank bioreactor systems are a platform that can address this limitation and have been proven effective for microcarrier-based production of adherent cell therapies. Implementation of optimized process control strategies for parameters such as dissolved oxygen (DO) and agitation rate are key to making an efficient transition from planar culture to stirred tank bioreactors. Herein, a stepwise approach to process development for MSC expansion in a small-scale single-use bioreactor is presented. Case studies focus on strategies to optimize DO control and agitation rates for bone marrow derived MSCs in microcarrier culture, highlighting improvements in process efficiency. In the first case study, the impact different gassing methods have on DO control and whether hypoxic growth conditions affect MSC function are examined. The second case study demonstrates the application of Zwietering’s equation for suspension of solids to overcome scaling challenges often associated with microcarrier culture in stirred tanks. Strategies to further improve the seeding process for bioreactor culture will also be reviewed. Identifying optimal seeding and process control strategies for microcarrier-based bioreactor expansion of adherent cells is paramount for the development of robust cell therapy manufacturing platforms.
In this webinar, you will learn about:
· Process development approaches for production scale-up of mesenchymal stem cells (MSCs)
· Implementing single-use, closed systems for manufacturing cell therapies
· Case studies focusing on strategies to optimize DO control and agitation rates for microcarrier-based cultures
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Similar to The Biocontinuum™ Seed Train Platform (20)
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...Merck Life Sciences
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMerck Life Sciences
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...Merck Life Sciences
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...Merck Life Sciences
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...Merck Life Sciences
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...Merck Life Sciences
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...Merck Life Sciences
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Insights from a Global Collaboration Accelerating Vaccine Development with an...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMerck Life Sciences
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 ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing
Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...Merck Life Sciences
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
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.
Regulatory Considerations for Excipients used in Lipid NanoparticlesMerck Life Sciences
Lipid excipients and delivery systems such as lipid nanoparticles (LNPs) are essential for a wide variety of therapeutics including mRNA vaccines and therapeutics and gene therapy.
The purity and safety of novel, synthetic lipid excipients must be demonstrated due to their central role in the function of the drug product, distinct physicochemical properties, and the potential for interaction with other ingredients or the physicochemical environment. These excipients must comply with challenging and complex regulatory requirements, similar to those expected of the active pharmaceutical ingredient itself.
This whitepaper provides an overview of the regulatory classification of lipid nanoparticles, liposomes and novel excipients. Specific requirements outlined in guidance documents are shared along with strategies to stay ahead of emerging regulatory challenges.
To find more information about synthetic lipids for pharmaceutical applications and gene therapy, please visit our website:
https://www.sigmaaldrich.com/DE/en/products/pharma-and-biopharma-manufacturing/formulation/synthetic-lipids
https://www.sigmaaldrich.com/US/en/products/pharma-and-biopharma-manufacturing/formulation/synthetic-lipids
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Explore our infographic on 'Essential Metrics for Palliative Care Management' which highlights key performance indicators crucial for enhancing the quality and efficiency of palliative care services.
This visual guide breaks down important metrics across four categories: Patient-Centered Metrics, Care Efficiency Metrics, Quality of Life Metrics, and Staff Metrics. Each section is designed to help healthcare professionals monitor and improve care delivery for patients facing serious illnesses. Understand how to implement these metrics in your palliative care practices for better outcomes and higher satisfaction levels.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
1. Merck KGaA
Darmstadt, Germany
Habib HORRY, Ph.D.
Asia BioForum, Fall 2020
Driving value and innovation toward the evolution of
upstream processes
The BioContinuumTM
Seed Train Platform
2. 2
The life science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.
3. Speed
Reduce new facility build
times by 70%. Compress
production lead time by
80%.
Quality
10X robustness.
90% reduction in cost of
poor quality.
Flexibility
Reduce product change-over
time by 90%.
Cost
90% reduction in cost to
manufacture and CAPEX.
Business
Drivers
Market
Growth
Uncertainty
New Product
Classes
Cost
Pressure
Market
Trends
Process
Intensification
Process
Analytics
Software &
Automation
Key
Enablers
Single Use
* Source: BioPhorum (BPOG)
https://www.biophorum.com/category/resources/technology-roadmapping-resources/introduction/
Market Trends, Business Drivers and Key Enablers to
Drive Next Generation BioProcessing:
BioContinuumTM Seed Train Platform | Fall 20203
4. Faster
Going as quickly as possible to purification
Higher
Getting as much protein as possible
Stronger
Achieve the highest product quality
Less contamination, Aggregates, Charge variants,
Glycosylation patterns, Cell debris, Insoluble impurities (DNA, HCP)
Upstream Process Intensification
What does that mean concretely?
BioContinuumTM Seed Train Platform | Fall 20204
5. Upstream Process Intensification for mAbs
A Multitude of Strategies all based on perfusion technology
5
Batch
x
1-2ml
each
10-30 x106 vc.ml-1
N-1
or
x
Batch
N
Fed Batch
MCB/MWCB INOCULATION TRAIN
SEED TRAIN
PRODUCTION
CRD
Perfusion
CRD
50-100 x106vc.ml-1
or or
4.5ml 50-500ml bagCRD
CRD
Perfusion
N
CRD
Continuous protein harvest
• Steady State Perfusion
• Dynamic Perfusion
Single protein harvest
• High Seed Fed batch
• Ultrahigh VCD Fed-Batch
• Concentrated Fed-Batch
Production
medium
Cryo Medium
Perfused Seed Train Processes
Can be utilized with any production method
Perfusion-based Production and Harvest processes
Continuous vs. single protein harvest, High cell densities, long durations
Expansion
medium
Cell Culture Media Formulations
Enabling intensified seed and production trains
High Qp
Low CSPR
Low OUR
High Shear resistance
Perfusion Optimized Cell Line
Maximizing protein yield and quality in perfusion operations
BioContinuumTM Seed Train Platform | Fall 2020
7. Evolving Guidelines for Next Generation Processes7
Poll Question
1. Where are you using (or going to use) perfusion in your process?
1) Seed Train (N-1 perfusion)
2) High Density Cell Banks
3) Production steady-state
4) Production dynamic perfusion
5) Not using / going to use perfusion at all
9. Perfused Seed Train
Different Scenarios
7
14 days
10 days
Conventional
Fed-Batch
(~ 0.2 E6 vc/mL)
High Seed
Fed-Batch
(~ 5 E6 vc/mL)
Conventional
(Batch N-1)
3 days
10L
3 days
100mL
3 days
30mL
5 days
60L,200L
Compressed
Seed Train
High Seed
(N-1 only)
High Seed
(N-1 & N-2)
3 days
400mL
3 days
2L
125mL 500mL 2X500mL 2X3L 20L
200L
2000L
7 days
10L
20L
3 days
10L
20L
9 days
60L,200L
200L
7 days
10L
20L
4 days
200L
200L
Same as above
Same as above
Same as above
2000L
Each model contains a
traditional downstream!
BioContinuumTM Seed Train Platform | Fall 2020
1 vs. 6 pack bioreactors
P:S ratio: 1:1 – 2:1 – 3:1
10. BioContinuumTM Seed Train Platform | Fall 202010
Constant Production Titer
Single Bioreactor scenario
13.5% reduction
in CoGs
38% Throughput
increase
Decreased duration
Perfused seed train allows for
more batches per year
No protein titer increase and shorter duration
CoG’s ($/g) 116 117 101 102
Throughput (kg/yr) 90 90 125 125
Batches/yr 18 18 25 25
11. BioContinuumTM Seed Train Platform | Fall 202011
Single Bioreactor scenario
Increased Production Titer 22-51% reduction
in CoGs
50-200%
Throughput
increase
Depending on titer increase
No additional batches
required
Increased Protein Titer and same duration
CoG’s ($/g) 116 101 120 91 76 57
Throughput (kg/yr) 90 125 90 135 180 271
Batches/yr 18 25 18 18 18 18
12. BioContinuumTM Seed Train Platform | Fall 202012
6-Pack Bioreactor scenario
Increased Production Titer
7-34% reduction
in CoGs
11-39% Throughput
increase
• Less batches per year than
traditional
Increased Protein Titer and same duration
Production/Seed 1:1
CoG’s ($/g) 67 85 85 62 52 44
Throughput (kg/yr) 496 276 276 413 551 689
Batches/yr 99 55 55 55 55 55
13. 13
Sensitivity Analysis
Media cost has moderate impact…as well
Media cost doesn’t significantly impact the overall cost of goods
CSPR .03
VVD control manual
Production: High Seed
CSPR .03
VVD control manual
Production: High Seed
Model: Perfused seed train pN-1 & pN-2
BioContinuumTM Seed Train Platform | Fall 2020
14. Summary
14
Perfused seed train:
Lower cost of manufacturing
Increase product throughput
while keeping production bioreactor in
fed batch mode
Potential for achieving higher titers,
especially when incorporating a
dedicated media platform
If higher titers observed:
• Adding additional seed trains and production bioreactors at
1:1 ratio brings the most benefit
• CoG’s reduced 24-52%, kg/yr increase 65-230%
• Benefits even at 3:1 and 2:1, with additional benefit of
needing less batches per year
If higher titers are not observed:
• Single bioreactor scenarios still see CoG’s reduced by 13.5%
and throughput increase of 39% at shorter high seed FB
duration
• Adding additional seed trains and production bioreactors
increases throughput
BioContinuumTM Seed Train Platform | Fall 2020
16. Evolving Guidelines for Next Generation Processes16
Poll Question
2. What considerations do you have on implementation of N-1 perfusion? (multiple
choices)
1) Footprint of manufacturing equipment
2) Process complexity and time duration
3) Cost of media and/or consumables
4) Impact on production (titer and/or product quality)
5) Other
6) N-1 perfusion is not applicable to my process.
18. Cell Culture Media requirements for intensified upstream processing
VCD
1 2 3 4
No adaptation to Perfusion
production
No cell damage during
freezing and thaw
Fast growth with minimum or
zero lag phase
Constant growth rate and
specific productivity over
thaw, expansion, and
production
EX-CELL® Advanced
18 BioContinuumTM Seed Train Platform | Fall 2020
19. E xp a n sio n in E xM E x p a n s io n in E x -C E L L ® A d v a n c e d H D P e rfu s io n M e d iu m
0 5 1 0 1 5
0
2 0
4 0
6 0
8 0
5 0
6 0
7 0
8 0
9 0
1 0 0
d a y s
VCD[10
6
VC/ml]
Viability[%]
0 5 1 0 1 5
0
2 0 0
4 0 0
6 0 0
d a y s
IgG[mg/l]
N-1 N N-1 N
Cellvento® 4CHO-X Expansion Medium
Compatibility with EX-CELL® Advanced HD Perfusion Medium
STR glass bioreactor
CHO-S
Working Volume: 2 L
Conditions either adapted and
passaged to ExM or
EX-CELL® Advanced HD Perfusion
Medium
Set-Up:
Start of N-1 bioreactor
Simulation of inoculation
N stage bioreactor
Bleeding of N-1 bioreactor
to starting cell density
N-1 and N runs both operated in
perfusion using an ATF for cell
retention
N-1: CellVento® 4 CHO X or EX-CELL® Advanced HD Perfusion Medium
N: EX-CELL® Advanced HD Perfusion Medium for both conditions
+18%
Expansion in
CellVento® 4 CHO X
19 BioContinuumTM Seed Train Platform | Fall 2020
20. Cellvento® 4CHO-X Expansion Medium
Compatibility with Cellvento® 4CHO Fed-Batch Platform
0 5 1 0 1 5
0
5
1 0
1 5
0
5 0
1 0 0
d a y s
VCD[10
6
VC/ml]
Viability[%]
0 5 1 0 1 5
0
3 5 0
7 0 0
1 0 5 0
1 4 0 0
d a y s
IgG[mg/l]
E xp a n sio n in E xME xp a n sio n in C e llv e n to ® 4 C H O
STR glass bioreactor
CHOZN® GS cell line
Working Volume: 750 ml
Conditions either adapted
and passaged to ExM or
Cellvento® 4CHO
Fed-Batch in Cellvento®
4CHO and Cellvento® 4Feed
Platform
n=2 (solid and dashed line)
20
+ 20%
BioContinuumTM Seed Train Platform | Fall 2020
21. Cell Culture Media Design principles
BioContinuumTM Seed Train Platform | Fall 2020
Formulation Secure
supply
easy
handling
• Media prototype evaluated
for solubility
• Exchange to better soluble
raw materials
• Focus on simple hydration
• Selected raw materials in
formats with robust supply
chain
• Lean formulation to reduce
raw material broadness
• Respecting safety aspects in
product handling
• Reduced dust formation for
ease of handling with
compaction technology
• Ready for CCM EMPROVE®
program
21
23. Evolving Guidelines for Next Generation Processes23
Poll Question
3. What difficulties do you have on current use Cell Retention Technology? (multiple
choices)
1) Difficult to use, Complexity on operation
2) Long time for setting up of utility and/or device
3) Trouble with flushing due to large scale
4) Low scalability
5) Other
6) No problem. Everything going well.
7) Cell Retention Technology has not applied to my process yet.
25. Delivering on the need
CelliconTM perfusion filter and controller
25
o High-capacity, supports high cell
densities
o Reliable and reproducible, low risk
of failure
25
Ready to Use in
Minutes
Superior Performance
Complete, Linearly
Scalable Offering
o Supplied as a complete assembly
(filter, sensors, pump)
o Dry (no flushing required)
o Gamma irradiated
o Sterile weld (PD), sterile connector
(pilot & process)
0
2
4
6
8
0 2000 4000 6000 8000
TMP(psi)
Throughput (L/m2)
190111 BRX 1 181121 BRX 2
180911 BRX 3
o Proven linear scalability from 3-50 L
o Complete offering from bench to 2000L
0
20
40
60
80
100
120
0 2 4 6
VCD(E6cells/mL)
andViability(%)
Duration (days)
Viable Cell Denisty Viability
1L
50L
200L
1000L
2000L
BioContinuumTM Seed Train Platform | Fall 2020
26. High Seed Fed Batch Process Development
Experimental Design
26
Bioreactor: 3L Mobius® bioreactor, 1.5 L WV
Inoculation Density: Control and Standard Density: 0.5e6 cells/mL, High Seed: 5e6 cells/ml
Basal Media: EX-CELL® Advanced
Feed Media: 50:50 Blend of EX-CELL® Advanced and Cellvento® 4Feed
Duration: 14 day process
N-1 Perfusion
3L High Seed
FB Bioreactor
3L Standard Seed
FB Bioreactor
(0.5e6 cells/mL)
(5e6 cells/mL)
Batch
x
1-2mL
10 - 30 E6 vc/mL
WCB Inoculum train
1-2mL
10 - 30 E6 vc/mL
Control
WCB Inoculum train
Batch
x
3L Standard Seed
FB Bioreactor
(0.5 e6 cells/mL)
Bioreactor Settings:
• Temp: 36.8 ºC
• Agitation: 200 rpm
• pH: 6.90 +0.1/-0.15
• DO: 50%
• Headspace air: 50
mL/min
• Sparge: open-pipe
*Each run performed in
duplicate
BioContinuumTM Seed Train Platform | Fall 2020
27. High Seed Fed Batch Production Process vs. Fed-Batch
Experimental Results 3L Scale
27
0
5
10
15
20
25
30
35
- 2 4 6 8 10 12 14
VCDX1E6
Days
Viable Cell Density
0%
20%
40%
60%
80%
100%
120%
- 2 4 6 8 10 12 14
%
Days
Viability
0
1
2
3
4
5
6
- 2 4 6 8 10 12 14
g/L
Days
Titer
0
5
10
15
20
25
- 2 4 6 8 10 12 14 16 18 20
pg/cell/day
Days
Qp
3 days earlier
Titer
Increase
Within
variability range
Within
variability range
BioContinuumTM Seed Train Platform | Fall 2020
28. High Seed Fed Batch Production Process vs. Fed-Batch
Experimental Results 3L Scale (Continued)
28
0
1
2
3
4
5
6
7
8
- 2 4 6 8 10 12 14
mM
Days
Glutamine
0
2
4
6
8
10
12
- 2 4 6 8 10 12 14
mM
Days
Glutamate
Increased
with feeds
0
2
4
6
8
10
12
14
- 2 4 6 8 10 12 14
g/L
Days
Glucose
0
1
2
3
4
5
6
- 2 4 6 8 10 12 14
mM
Days
Ammonia
Higher
VCD
Lower
viability
Unclear
drop
BioContinuumTM Seed Train Platform | Fall 2020
29. High Seed Fed Batch Production Process vs. Fed-Batch
Experimental Results 3L Scale (Continued)
29
0
0.5
1
1.5
2
2.5
- 2 4 6 8 10 12 14
g/L
Days
Lactate
Follows VCD Shift
10
30
50
70
90
110
130
150
- 2 4 6 8 10 12 14
pCO2(mmHg)
Days
pCO2
CO2 needed for pH control
consistent with lactate trend
0
10
20
30
40
50
60
70
80
90
100
Ctrl A Ctrl B pN-1 0.5A pN-1 0.5B pN-1 5.0A pN-1 5.0B
PeakArea(%)
Size Exclusion Chromatography
consistent product
quality across conditions
0
10
20
30
40
50
60
Ctrl A Ctrl B pN-1 0.5A pN-1 0.5B pN-1 5.0A pN-1 5.0B
PeakArea(%)
Charge Analysis
Correlated to lower pH resulting
from increasing lactate level
BioContinuumTM Seed Train Platform | Fall 2020
32. Summary
Integrated Technologies…
BioC
Cellicon™ Perfusion Filter and
Controller offers:
• Increased ease of use
• Simplicity of use
• Reduced footprint
High Seed Fed-Batch offers
• Lower cost of manufacturing
• Increase product throughput
• While keeping production bioreactor in
fed batch mode
CellVento® 4CHO-X offers:
• State of the art cell culture media
platform for intensified seed train
• Adaptation to production not required
for perfusion and fed-batch
32
…Upstream Process Evolution Powered
BioContinuumTM Seed Train Platform | Fall 2020
33. 33
Acknowledgements:
Jochen Sieck
Alison Dupont
Jeffrey Barna
Mona Bausch
Aline Zimmer
Delia Lyons
Melanie Brandl
Douglas Rank
…
and all the great collaborators
from around the world