Two of the biggest challenges with applying traditional quality control (QC) test methods to cell and gene therapies, is time to results, due to short shelf-life, and availability of sufficient sample, due to small production volumes. So how can we overcome these challenges while still meeting regulatory expectations? In this webinar, we will discuss and review suitable methods for rapid testing of short-life cell and gene therapies that may also help conserve limited production material. We will look at the benefits, limitations, and regulatory expectations for various QC needs, including current and future rapid methods for sterility, mycoplasma, and replication-competent virus.
In this webinar, you will learn:
- Why the shelf life of a cell or gene therapy product may impact your QC testing strategy
- Current regulatory expectations surrounding rapid methods for sterility, mycoplasma, and replication-competent virus
- Potential impacts of pursuing a non-optimal QC testing strategy
Speakers
Kyle Reder
Merck
Segment Strategy Manager for Cell & Gene Therapy
Kyle Reder is a segment strategy manager for cell & gene therapy, supporting BioReliance® biosafety testing services. With more than 10 years of experience as a biologist, technical specialist, and product manager supporting cell and gene therapy manufacturers, Kyle provides insights into business and technology trends across the CGT landscape. Kyle has a B.Sc. in biomedical sciences from the University of Lynchburg.
Sarah Sheridan, Ph.D.
Merck
Technical Consultant
Sarah Sheridan is a technical consultant, supporting the BioReliance® Biosafety Testing Services. Drawing on more than 27 years of experience in the human and animal health biotech industries, Sheridan provides scientific, technical, and regulatory consultancy for the company’s global client base to support pre-clinical to commercial phase biosafety testing of client-manufactured products spanning monoclonal antibodies to vaccines and cell and gene therapies. Sheridan has a Ph.D. in virology from the University of Cambridge, U.K., and a B.Sc. honors degree in life science.
Pharma and biopharma manufacturing
- Compendial Testing and Regulatory Guidance
Duration:1hr
Language:English
Session 1:presented April 8, 2021
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