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.
Merck
Technology Lead, Product Characterization
Martin De Cecco is the technology lead for product characterization at Merck, overseeing the development of new analytical testing services. Martin has over 12 years’ experience developing methods for the characterization of novel biotherapeutics, having worked in the CRO industry and previously at a leading LC-MS vendor. He holds a Ph.D. in biophysical chemistry and an MSci degree in Forensic & Analytical Chemistry.
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.
Pharma and biopharma manufacturing
- Gene therapy manufacturing
Duration:50min
Language:English
Session 1:presented June 8, 2021
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