As the application of lentiviral (LV) vectors continues to expand, understanding the critical aspects of biosafety testing and quality control becomes paramount. This webinar explores the latest advancements in release testing of LV vectors, focusing on the key requirements for ensuring patient safety and therapeutic efficacy. You will gain insights into the regulatory landscape for performing release testing, including methodologies for the detection of RCL and for determining infectious titer. We will discuss challenges such as availability of sample volume and limited batches for qualification and introduce effective solutions to avoid unwelcome surprises and to expedite time to clinic.
In this webinar, you will:
- Gain familiarity with regulatory requirements for release testing of lentiviral vectors.
- Reflect on testing strategies for biosafety including detection of RCL and determination of infectious titer and how these techniques can enhance product safety and consistency.
- Learn how to navigate quality control challenges and explore solutions for efficient testing processes that minimize time and material usage while ensuring therapeutic efficacy.
Speakers

Sarah Sheridan, Ph.D.
Merck
Technical Consultant
Sarah Sheridan provides scientific, technical, and regulatory consultancy on biosafety testing, including services offered under the BioReliance® Testing Services portfolio. Drawing on over 25 years of experience in the human and animal health biotech industries, Sheridan supports the company's global client base spanning pre-clinical to commercial phase biosafety testing of client manufactured products including vaccines, monoclonals and cell & gene therapies. Sheridan is an active member of several industry forums and holds a Ph.D. in veterinary science from the University of Cambridge, UK.

Kenneth Jensen, Ph.D.
Merck
Senior Scientist
Kenneth Jensen is a senior scientist supporting the virology operations team. For the past 5 years, Ken has supported cell and gene therapy release testing, serving as a subject matter expert focusing on replication-competent AAV and rAAV infectious titer testing. Prior to joining Merck, Ken worked at the NIH’s Integrated Research Facility supporting the 2014-2016 Ebola outbreak in Liberia and the PREVAIL and PREVAC Clinical Studies. Ken has a Ph.D. in virology from the University of Maryland.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:45min
语言:English
场次 1:往期 March 13, 2025
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