Live Webcast:
Gene Therapy Development: From Methods to GMP Testing
Thursday, August 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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
Who Should Attend:
- Formulation and analytical scientists
- Executives in charge of CMC Development
Speakers:
Benjamin Buer is an associate director of pharmaceutical sciences at Pace Analytical, an integrated CMC drug product development CRO. Ben is an expert in pharmaceutical R&D and leads biologics drug product development by applying his deep knowledge of biophysical characterization and analytical methodology to design stabilizing formulations. Benjamin is the author or co-author of 11 publications and received a doctorate in chemical biology from the University of Michigan.