Connecting ATMP Discovery to Commercial: Improving Manufacturability

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

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Erich H. Bozenhardt
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Zhimei Du
Vice President
Landmark Bio
George Todorov
Senior Process Specialist