INSIGHTS ON DOWNSTREAM MANUFACTURING
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![Argonaut]( "Maximizing Yield And Minimizing Risk In Aseptic Filling")
Maximizing Yield And Minimizing Risk In Aseptic FillingExplore the process of how a new fill line was planned for and implemented, while also considering how best to mitigate contamination risks.
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![Gene Therapy]( "Quality by Design (QbD) for Adeno-Associated Virus (AAV)")
Quality by Design (QbD) for Adeno-Associated Virus (AAV)Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest obstacles when moving towards regulatory approval and presents a significant risk to the success of new gene therapy drug candidates today. Here we review a framework for a QbD assessment for AAV products within the Chemistry Manufacturing and Controls (CMC) documentation.
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![908 Screenshot]( "The Importance Of Cell Media Analysis In Upstream Bioprocess Development")
The Importance Of Cell Media Analysis In Upstream Bioprocess DevelopmentExperts from industry and academia to explore current trends in upstream bioprocessing and the impact of real-time cell media analysis on process improvements and process analytical technologies.
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![Adenovirus iStock-1315994897]( "Application Of Two-Dimensional Chromatography To Improve Productivity Of Analytical Testing Of Cell & Gene Therapy Products")
Application Of Two-Dimensional Chromatography To Improve Productivity Of Analytical Testing Of Cell & Gene Therapy ProductsAnalytical characterization of cell and gene therapy products remains a challenging, costly, and time-consuming task. In this video we present a proof-of-concept work demonstrating application of multidimensional chromatography for characterization of Adenovirus type 5 (Ad5)-based product that not only allowed increased productivity, but also limits the sample volume needed for the analysis.
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Unveiling The Potential Of Your AAV Gene Therapy: Orthogonal Methods To Understand And Define CQAs10/13/2021
As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of these products to ensure their safety and efficacy. Our experts present a range of orthogonal methods to understand and define the CQAs of AAV products.
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Production Of Therapeutic Proteins In CHO Cells10/12/2021
Despite the widespread use of CHO cells in therapeutic protein production, the presence of many CHO cell line options and the need to optimize cell culture conditions for every cell line in a product-specific manner can lead to extended timelines and substantial cost in the development of a cell line for a new biologic.
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New Technology Adoption In Aseptic Filling: Risk Aversion vs. Change Aversion10/12/2021
Change is an inevitable part of continuous improvement, and risk-mitigated, disruptive advances should be embraced as enthusiastically as incremental change.
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Optimizing Viral Vector Production And Efficiency While Saving Potential Costs With Osmolality10/7/2021
Process development is a critical part in both upstream and downstream and in recent years, osmolality, a measure of solute concentration, has been shown to be strongly implicated across the entire gene therapy process workflow. Data from a recently completed study shows that a significant increase in yield and quality of an AAV was realized from a timed osmolality shift.
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A Multifaceted Strategy For Viral Safety In AAV Processes10/7/2021
Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.
DOWNSTREAM MANUFACTURING SOLUTIONS
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![Pall Sample Prep]( "Sample Prep For Research Laboratories Simplified")
Pall Laboratory develops and produces many different membrane chemistries and devices for a multitude of applications. We offer products for molecular purification and characterization, media prep, analytical chemistry and microbiology.
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![VirusExpress_AAV_Diagram_R8-01]( "VirusExpress™ 293 AAV Production Platform")
You’re developing lifesaving gene therapies and need to manufacture AAV vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive. We’re here to help.
The VirusExpress™ 293 AAV Production Platform offers a transfection-based solution using a suspension-adapted cell line, which is GMP banked and characterized, chemically defined medium, and a process with proven performance at clinically relevant scale.
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![Millipore1]( "Single-Use Fluid Management")
Mobius® 2D and 3D assemblies, filtration, storage and transportation solutions are key components for efficient, ergonomic and scalable single-use fluid management. This interactive brochure is designed to provide you with an overview of our complete single-use fluid management offerings, and a detailed guide to a holistic risk mitigation approach to quality control and assurance to meet your regulatory and compliance needs.
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This document describes how to perform small scale virus filtration studies with Vmax™ filter sizing method, to assess the performance of any feed solution on a virus filter, and how to use the results of the small scale study to predict the virus filter area requirements for larger, production scale processes.
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Membrane filtration is a critical virus reduction step in most established and new biologic production processes. However, even for highly purified process intermediates, protein aggregates and other impurities can limit the throughput capacity of virus filters, increasing filter area requirements. To mitigate these challenges, many filtration operations include prefilters to improve the capacity of virus filters, consistency of process runs, and enhance process economics.
