Gene Therapy Development: From Methods to GMP Testing

Register free: http://www.pharmtech.com/pt_w/gene_therapy_development

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: http://www.pharmtech.com/pt_w/gene_therapy_development