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HomeWebinarsUnveiling the Potential of your AAV Gene Therapy: Orthogonal Methods to Understand and Define CQAs

Unveiling the Potential of your AAV Gene Therapy: Orthogonal Methods to Understand and Define CQAs



WEBINAR

The potential of gene therapies to cure previously untreatable diseases has spurred the development of novel drugs, including those based on Adeno-Associated Virus (AAV). As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of these products to ensure their safety and efficacy.

In this webinar, we will present a range of orthogonal methods to understand and define the CQAs of AAV products. These include assays for the confirmation of capsid protein identity and quantity, as well as the characterization of important product-related impurities, such as aggregates. Together these methods represent a comprehensive analytical testing package to support the characterization and lot release of AAV products.

In this webinar, you will learn:

  • How to identify and monitor the critical quality attributes (CQAs) of your AAV therapy
  • What assays to utilize to confirm capsid protein identity and quantity
  • Why you need to look to product characterization to identify and remove important product-related impurities

Speakers

Martin De Cecco, Ph.D.

Martin De Cecco, Ph.D.

Merck

Development Services Manager, Product Characterization

Martin De Cecco leads a global team working on the development of new services for product characterization. He has more than 10 years of experience developing methods for the characterization of biopharmaceuticals, having worked in the CRO industry and previously at a leading LC-MS vendor. He holds a Ph.D. in biophysical chemistry from the University of Edinburgh and an M.Sc. in forensic & analytical chemistry from the University of Strathclyde.

Piotr Kaczmarek, Ph.D.

Piotr Kaczmarek, Ph.D.

Merck

Principal Scientist, Analytical, Testing R&D Services

Piotr Kaczmarek joined the organization in 2013 to focus on the execution and development of analytical assays. He earned his MSc and Ph.D. in chemistry at the Faculty of Chemistry at the University of Wroclaw in Poland. He completed his postdoctoral training at the Massachusetts Institute of Technology in Cambridge, MA, and the National Cancer Institute in Frederick, MD.

Webinar Information

Pharma and biopharma manufacturing

  • Gene therapy manufacturing
  • Duration:30m

  • Language:English

  • Presented:Tue, June 8, 2021

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