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Releasing Your AAV Therapy with Confidence



WEBINAR

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

Steven McDade

Merck

Senior Technical Specialist, Field Technology Management

Steven McDade has worked in the biosafety testing field for more than 20 years, 15 of which have been focused on the BioReliance® service portfolio. During this time, Steven has worked in a variety of roles, including technical sales manager for the Asia Pacific region, account manager for UK, Ireland & Scandinavia, and business development manager for clearance services (EMEA & Asia). In his current role as senior technical specialist, Steven provides regulatory and scientific support for our European clients. Steven earned a BSc (Hons) in microbiology from Glasgow University.

Alfonso Lavorgna, Ph.D.

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.