From Research To Reality: Overcoming CMC Challenges In Cell & Gene Therapy

Translating a research and development (R&D) asset into a human therapeutic is a high-risk endeavor, often complicated by a variety of development and manufacturing challenges. Biomanufacturers must have a deep understanding of both the process and the product to optimize manufacturing operations, ensure regulatory compliance, and address any issues that arise during the development cycle.

Small biopharma companies and academic institutions frequently face significant hurdles in these areas due to limited resources, specialized expertise, and the time required to develop a comprehensive and robust manufacturing process. In this context, crafting a Chemistry, Manufacturing, and Controls (CMC) strategy becomes essential to mitigate risk, proactively identify gaps in process, analytics, and compliance, and prevent costly delays.

Partnering with an experienced team to help develop a solid CMC strategy is vital when transitioning from a research-focused mindset to a commercial one. This webinar will explore the importance of adopting a Quality by Design (QbD) approach in the development process while integrating regulatory and CMC strategies for maximum efficiency and benefit.

The session will provide an introduction to:

• How to develop and define a Target Product Profile (TPP) and Quality Target Product Profile (QTPP), and implement Quality by Design.
• How to build and implement an integrated regulatory and CMC strategy.
• How to develop and implement phase-appropriate Good Manufacturing Practice (GMP) manufacturing processes.