Cell & Gene Therapy Products – CMC & Quality Requirements

Cell & Gene Therapy Products – CMC & Quality Requirements is organized by Fleming and will be held from Nov 26 - 28, 2025 at Barcelona, Barcelona, Spain.

Description:
With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in development, unique challenges have emerged especially in manufacturing and control. Leading biotech players are utilizing available regulatory pathways to accelerate the approval of ATMPs. However, the pathways to meeting CMC requirements are not as clearly defined. Novel approaches must be taken to ensure the identity, strength, quality, purity or potency of the product.

This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.

Join us & achieve CMC readiness for your cell & gene therapy medicinal products.

Topics:

• The ATMP regulatory framework
• Quality of raw materials & starting materials criteria
• Process development & manufacturing strategy
• Process validation requirements
• Method validation/qualification strategies
• Release specifications for ATMPs
• Analytical characterization & comparability
• Data requirements for manufacture and control
• Gene therapy product class specificities
• Manufacturing process changes/ Change control