Connecting ATMP Discovery to Commercial: Improving Manufacturability
Complimentary
Learning Level: Intermediate
Time: 1100 - 1230 ET
Session Length: 1.5 hour
Peter Marks of the FDA has spoken a number of times about the high number of clinical holds and withdrawals of cell and gene therapy trials including the lack of a manufacturing controls or even a manufacturing section in the IND. At the same time, companies are utilizing accelerated pathways to approval. This yields processes that don’t translate well into commercial manufacturing due to scalability and/or process robustness. This session will cover some best practices of how to structure the discovery-CMC interface as an overarching approach to manufacturing and regulatory for all ATMPS, discuss life cycle and comparability considerations for AAVs, and present a real-world example of closing the discovery to CMC gap.
Learning Objectives
- To highlight the challenges and provide best practices associated with development and scale-up of ATMPs including:
- Enabling the academic science community to advance their groundbreaking biological discoveries to preclinical/clinical studies
- Improve developability and manufacturability
- Accelerate speed from Discovery to Clinic
- Reduce comparability challenges at later stage of development
- To discuss the best practices in lifecycle management and compatibility for AAV gene therapy
- To relate ATMP development concepts to real world experience via a case study
