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|Webcasts|August 5, 2020
Gene Therapy Development: From Methods to GMP Testing
Author(s)Pace Analytical Life Sciences
The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. This webcast will provide insights into characterizing viral and non-viral gene therapies to ensure quality. Live: Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 20, 2021
Register free:
Event Overview:
The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. Discriminating, stage-appropriate, analytical and biophysical tools are key to fully characterizing and understanding routes of degradation that are unique to each drug substance on the path to producing a stable product and meeting rigorous safety guidelines. This webinar will provide insights into:
- Characterizing aggregates to control stability and purity
- Stability challenges faced during formulation and process development
- Integrating analytical results for a complete picture of quality
Key Learning Objectives:
- Recognize the relationship between chemical degradation and physical instability of therapeutic macromolecules and how to address this through formulation
- Review the CMC requirements for gene therapies
- Observe a demonstration of analytical methods to assess gene therapy quality attributes
Speaker: Benjamin Buer, Ph.D., Associate Director, Pharmaceutical Development, Pace Analytical Life Sciences
Time and date: Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
On demand available after airing until Aug. 20, 2021
Sponsor: Pace Analytical
Register free:
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