Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy, including high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors.
This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication-competent AAV testing and infectious titer determination by TCID50.
In this webinar, you will learn:
- Critical biosafety considerations for AAV vectors based on the latest regulatory guidance
- How replication-competent AAV testing fits into your bulk and final release testing package
- The benefits of routine and platform assays over custom assay development
Speakers
Steven McDade
Merck
Associate Director, Sales Development, APAC
Steven McDade is an associate director of sales development APAC, responsible for supporting customers on virus clearance capabilities and providing technical and regulatory support. Steven has worked in the biosafety testing field for more than 24 years, 18 with BioReliance® contract testing services. He has worked in a variety of roles including technical sales manager in APAC, business development manager for clearance services, EMEA & Asia, and senior technical specialist for the cell and gene therapy portfolio. Steven graduated with a BSc (Hons) in microbiology from Glasgow University in 1999.
Alfonso Lavorgna, Ph.D.
Merck
Operations Manager, Virology Services
Alfonso Lavorgna has worked in the biosafety testing field for 6 years focused on the BioReliance® service portfolio. During this time, Alfonso has worked as a scientist overseeing development and validation of a wide variety of safety testing required to manufacture clinical and commercial products. In his current role as Operations Manager, Alfonso oversees the daily management of a wide variety of assays or tests required to characterize product or material safety. Alfonso earned his M.S. in medical biotechnology from the University of Naples in 2005 as well as a Ph.D. in viral oncology in 2009.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:50min
Language:English
Session 1:presented June 29, 2021
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