FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing


16th October 2019 | 10.00 am EST | Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead |WATCH FOR FREE

The manufacturing processes for cell therapy products can be highly complex, non-conventional, and product-specific. Aseptic techniques are often required throughout manufacture. The challenge to appropriately and effectively validate aseptic processing requires that industry and regulatory bodies rethink how validation strategies are best applied to this novel class of products. This presentation will address FDA perspective on aseptic process simulation for cell therapy products. It will highlight some unique manufacturing/processing features that are shared among cell therapy products and should be considered during aseptic process simulation study design. The presentation will also cover elements of the traditional validation approach and how they could be appropriately applied to cell therapy manufacturing. Case studies will be presented and discussed.

FDA Perspective Presented by Lily Koo, PhD. Consumer Safety Officer at Food and Drug Administration

Lily Koo is a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her primary responsibilities include review of facility and equipment information in license applications and supplements for viral vaccines, blood fractionation products, cell and gene therapy products, and in vitro diagnostic kits. Lily also conducts pre-license and pre-approval inspections of biological manufacturing facilities. Prior to joining CBER, she worked two and half years at the Center for Device and Radiological Health and ten years at the National Institutes of Health. Lily received her B.S. in bioengineering from the University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.

Followed by Process Control Strategy to Mitigate Contamination Risk of an Aseptic Viral Vector Production

Adeno-associated virus (AAV) vectors are potent gene therapy vectors, used to deliver therapeutic transgenes to target tissues. Gene therapy clinical trials often require high titer vector preparations to adequately deliver the therapeutic transgene, in great excess of research-level production utilized in many laboratories. To bring the virus into the pre-clinical and clinical phases, Pall Biotech simplified, optimized and scaled-up the current upstream and downstream process of viral vector production to industrial scales using the fully-closed, single-use Xpansion® multiplate seed train bioreactor and the production packed-bed iCELLis® 500 single-use bioreactor. In these processes, it is important to ensure that steps are built into the process to ensure adequate control of adventitious agents. Cell culture media filtration is one important technique that can be used for this purpose. Pegasus™ Prime virus removal filters can be used to mitigate the risk of viral contamination of cell culture media. They show robust performance, are easy to implement and use, making them an ideal technology to minimize the risk of upstream and downstream viral contamination. High-flux viral filtration allows for rapid, scalable processing from laboratory scale to commercial manufacturing. In this webinar, we will address how to mitigate the risk of contamination by adventitious agents to ensure viral vector safety used in biotherapeutics.

Industry Perspective Presented by Keen Chung Ph.D. , Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead

Dr. Keen Chung, Ph.D. is a Principal Scientist, cell culture PDS laboratory in the Cell Culture Technologies Group within the Single Use Technology (SUT) Biotech business unit at Pall Life Sciences. He completed his Ph.D. in Molecular Toxicology at the Penn State University College of Medicine, Hershey, PA. In 2013, He joined the Internal Medicine department at UT Southwestern Medical Center at Dallas, TX and was part of the cancer targeting peptide development team for drug delivery and tumor imaging. In this role he also participating in assay development for analytics. In 2014, Keen and the team joined the non-profit organization, SRI International. His contributions included unravelling Integrin signaling pathways for Head and Neck cancer development. In this role, he worked on tumor specificic peptide drug conjugation to deliver payload to develop translational therapy to inhibit tumor progression. He joined Pall Life sciences PDS in 2016 as a senior scientist leading bioanalytical team for gene therapy viral vector analytics. As a leader of the team, his responsibilities included assisting analytics tech transfer, develop analytical SOP, processing upstream and downstream processes samples for titers and inpurities, ensuring data robustness, and finishing analytical request in a timely manner. To expand PDS analytical capabilities, he established SOPs and new assays using Danaher technologies. In 2018, he was promoted to principal scientist, except for his leader role in bioanalytics, he started leading projects for gene therapy upstream production in iCELLis and STR bioreactors.

 

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