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Live Webcast: Gene Therapy Development: From Methods to GMP Testing

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.