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
Danielle Hickman, Ph.D.
MilliporeSigma
Technical Specialist
Danielle Hickman, Ph.D. is a technical specialist in technical sales services team, supporting the BioReliance® Contract Testing Services portfolio. She provides scientific and regulatory guidance in biosafety testing and characterization of biological therapeutic products for the US East coast territory. Danielle has more than 9 years of industry experience performing viral clearance and biosafety testing for large molecules. Danielle received her doctorate in biological sciences from the University of Maryland, College Park, followed by postdoctoral training at the University of Florida, Gainesville.
Pamela Hamill, Ph.D.
MilliporeSigma
Technical Consultant, Field Technology Management
Pamela Hamill, Ph.D. is a technical consultant supporting the BioReliance® Contract Testing Services, providing clients with scientific and regulatory advice for quality control testing of biological therapies and novel modalities. Pam was previously principal scientist overseeing clients' custom potency assay development. Prior to this, Pam managed diagnostic services at the Rabies Centre of Expertise at the Canadian Food Inspection Agency and performed post-doctoral studies at the University of British Columbia. Pamela has a Ph.D. in virology from the University of Glasgow.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:Thu, April 10, 2025 4:00 PM CEST
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