Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality and therefore safety and efficacy of the product; this requires data beyond meeting current specifications. With any biological product this is challenging, for cell, gene and tissue products that cannot be fully characterized the challenges are greater still. Concerns about comparability undertaken during development are common issues raised during review and often delay market approval or contribute to failure. This course explains what comparability is and how to develop a successful comparability protocol.
Workshop Learning Overview
• What is comparability?
• Why is meeting existing specifications not comparability?
• How do I apply the principles of comparability to highly variable products?
• Case studies: Common mistakes with comparability and their consequences.
• Interactive exercise: Spot the weaknesses and propose improvements to a worked comparability study
Monday, September 25:
Refreshment Break: 10:15-10:45
Refreshment Break: 2:45-3:15