The FDA's Center for Biologics Evaluation and Research (CBER) will host a comprehensive workshop on August 15, 2025, focusing on the unique manufacturing challenges facing cell and gene therapy developers.

Workshop Overview and Objectives

This virtual workshop brings together industry experts, regulatory scientists, and academic researchers to address critical manufacturing issues that impact the development and commercialization of advanced therapies.

Key Workshop Sessions:

• Current Good Manufacturing Practice (CGMP) requirements for cell therapies
• Quality by Design implementation in gene therapy manufacturing
• Scale-up strategies and comparability assessment
• Supply chain management and distribution challenges
• Regulatory inspection readiness and compliance

Featured Speakers and Presentations

The workshop features presentations from leading experts in the field:

• Dr. Sarah Chen, FDA CBER: "Regulatory Perspectives on ATMP Manufacturing"
• Prof. Michael Rodriguez, MIT: "Innovations in Automated Cell Manufacturing"
• Jane Wilson, Industry Expert: "Commercial Scale-up Success Stories"
• Dr. Ahmed Hassan, FDA: "Quality Systems for Complex Manufacturing Processes"

Manufacturing Quality Systems Focus

A significant portion of the workshop will address quality system requirements:

• Risk-based approaches to quality assurance
• Process validation strategies for autologous products
• Equipment qualification in specialized manufacturing environments
• Change control procedures for evolving technologies
• Supplier qualification and oversight programs

Technology Transfer and Scale-up Challenges

The workshop will explore practical approaches to technology transfer:

• Laboratory to clinical manufacturing transitions
• Clinical to commercial scale manufacturing considerations
• Comparability protocols for manufacturing changes
• Site transfer strategies and risk mitigation
• Global manufacturing network considerations