Analyzing recombinant Adeno-Associated Virus (rAAV) can be challenging as significant portions of process development and clinical trial material batches are consumed during the measurement of critical quality attributes (CQAs). However, measuring specific rAAV CQAs such as identity and purity is an essential part of gaining process understanding, developing control strategies, and mitigating the risks associated with an AAV drug program.
In this webinar, you will learn about our approach to method development where we can measure more than one AAV CQA within a single analytical run. This small-volume AAV testing package reduces the amount of test material required so you can treat more patients.
In this webinar, you will learn:
- Key considerations for determining your AAV therapy’s critical quality attributes aligned with regulatory guidance
- Strategic orthogonal assays to confirm product identity and purity that conserve precious amounts of AAV material from your production batches
Speaker
Jason Sterling, Ph.D.
Merck
Global Business Lead, Product Characterization
Jay Sterling is the Global Business Lead, Product Characterization. Jay’s main area of expertise is in the development of physiochemical methods designed to measure the critical quality attributes of drug products, including monoclonal antibodies, vaccines, nanoparticles, and gene therapy delivery vectors. Previously. he worked at a variety of small biotechnology, large pharmaceutical, and contract research companies (including Biolex Tx, GSK Vaccines, and Catalent). Jay received his Ph.D. in biochemistry and molecular biology from the University of Georgia.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented April 25, 2023
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