The therapeutic application of AAVs for gene therapy is progressing, but there are complexities, like evolving manufacturing approaches, changing regulatory expectations, and progressive discernment of critical quality attributes. With potentially accelerated timelines and increasing market pressure, adoption of robust and comprehensive QC strategies is essential for ensuring product quality and safety and avoiding regulatory delays.
This webinar will address QC topics that are crucial to consider when navigating regulatory complexities and optimizing development timelines, with specific regards to replication-competent AAV, viral clearance, and impurities impacting product quality.
In this webinar, you will learn:
- How to manage challenges around determining absence of replication-competent AAV (rcAAV)
- The key updates in ICH Q5A that discuss viral clearance for AAV products
- How NGS can provide broad characterization of targeted and non-targeted sequences in an AAV particle
Speakers
Pamela Hamill, Ph.D.
Merck
Technical Consultant, Field Technology Management
Pamela Hamill is a subject matter expert for product characterization, providing technical, scientific, and regulatory support for clients and specializing in strategies to understand product critical quality attributes and the functional activity of biologics through the use of binding and bioassays.
Prior to joining the organization, Pamela managed a national Level III diagnostic lab and worked in academic research focused on innate immunity, novel host defense peptides, and the development of assays enabling analysis of viral proteases and antiviral drug screening. She holds a Ph.D. and M.Sc. from the University of Glasgow.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented April 10, 2025
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