As AAV-based gene therapies continue to demonstrate promising potential in the treatment of a wide range of complex indications, ensuring their safety and efficacy remains the top priority. In this webinar, discover the foundation for viable and reliable AAV production – a comprehensive analytical framework measuring consistent drug product delivery that meets quality targets and advances AAV development.
Learn how the implementation of orthogonal methods for analytical testing enhances quality, de-risks production, and improves clinical outcomes for AAV-based therapeutics.
In this webinar, you will:
- Understand the limitations of traditional methods for measuring AAV quality and the imposing risks to product safety
- Discover how incorporating AEX-HPLC and NGS methods into our analytical workflow has led to having an array of orthogonal methods to improve AAV characterization, purity, quality
- Explore how a CDMO partnership can de-risk production and position your AAV therapy for clinical and commercial success
Speakers
David Kush
Merck
Scientist I - Process & Analytical Development
David Kush brings more than 10 years of cGMP experience supporting a range of cross-functional CMC teams from early-phase to commercial programs. In his current role, David focuses on developing platform chromatographic separation techniques for the characterization of viral proteins and impurities while driving continuous improvement efforts in process development. In previous roles, he integrated analytical and QC processes through successful validation and transfer of analytical or compendial methods. David holds a B.S. in chemistry from UC San Diego.
Kelly Rios, Ph.D.
Merck
Scientist I - Analytical Development
Kelly Rios has more than 3 years of biopharmaceutical industry experience in genomics. In her current role, she develops analytical techniques for characterization of viral vector cell and gene therapies, with a focus on next-generation sequencing. Kelly earned a Ph.D. in biochemistry and molecular biology from Penn State University before transitioning to analytical development roles for cell and gene therapies.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
期间:1h
语言:English
场次 1:Thu, September 18, 2025 6:00 PM CEST
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