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HomeWebinarsTake the Reins of Your AAV-based Therapy: Ensuring Safety with Cell-based Analytical Testing

Take the Reins of Your AAV-based Therapy: Ensuring Safety with Cell-based Analytical Testing



WEBINAR

It’s no secret that AAV-based vectors are key tools for gene therapy-based therapeutics. It’s critical to increase our understanding of the host and vector-related immune response. Gaining insight into the mechanisms by which AAV infects the host cell can help to improve the safety and efficiency of AAV vectors. 

In this webinar, we’ll discuss the biology of AAV-host cellular interactions and the cell-based assays that can be used to establish product safety and infectivity. We will also review the possible development and modifications to meet the needs of novel and improved AAV vector systems. Finally,  we will discuss regulatory approaches in applying these assays for the release of AAV vectors. 

In this webinar, you will learn:

  • Regulatory expectations for determining AAV vector titer and absence of replication-competent AAV
  • Application of these methods in the QC laboratory
  • How to leverage validated systems and methodology to meet regulatory expectations for different AAV vectors

Speakers

Anna Woodward, Ph.D.

Anna Woodward, Ph.D.

Merck

Senior Technical Specialist

Anna Woodward joined Merck in 2019 and has more than 15 years of experience providing technical support to developers and manufacturers of small molecules and biologics. In her current role as a senior technical specialist, Anna supports the BioReliance® services portfolio and works closely with clients to provide scientific and regulatory guidance on biosafety testing packages. Anna holds a Ph.D. in cell biology from the University of Dundee, Scotland.

Cari Sadowski

Cari Sadowski

Merck

Principal Virology Scientist

Cari Sadowski is a principal virology scientist for development services. Cari’s main area of expertise is in the development of cell-based analytical methods for the characterization and release of viral vector-based therapeutics. She has worked at the NCI and DHS as a virologist and with a variety of biotech and pharmaceutical companies as a part of the CDMO sector. She has been an active member of the growing field of GCT analytics, and her work has been featured in numerous publications. She has also been an active member of BioPhorum, helping define the industry standard safety and analytical testing.

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