9:00 – 17:00, Monday 22 January
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 characterised the challenges are greater still. Concerns about comparability undertaken during development are common issues at approval with significant comparability concerns raised during 12 of the 17 ATMP submissions to the EMA. Such questions often delay market approval or contribute to failure to get approval. 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