Addressing Regulatory Requirements of Manufacturing Protocols to Gain Regulatory Agency Approval

Time: 8:35 am
day: Pre-Conference Day


This session is dedicated to unifying international regulatory expectations for cell line comparability and validation of technical approaches to improve the translatability of manufacturing protocol from research to industrial phases. Join to be part of a dialogue with regulatory agents, and brainstorm next steps under a unified understanding to accelerate the approval process.

Part 1 International Insights: Regulatory Perspectives on iPSCs in Medicinal Products from the UK

Part 2 Understanding US Requirements: FDA requirements for iPSC derived products

Key topics to be discussed:

  • Starting material quality to reduce downstream complications
  • Demonstrating comparability of cell lines to determine produce quality
  • Cell monitoring and administrational requirements to establish temporal and practical expectations of achieving regulator acceptance for your product
  • Analytical approaches and reference standards to ensure comprehensive data to increase regulatory acceptance