Project: Applying Quality by Design Principles to Gene Therapy Development

Type: OUtreach and Education Activity

PARTNERS: Alliance for Regenerative Medicine Science and Technology Committee (ARM S&T) and the SCB Gene Therapy Sector Working Group

DESCRIPTION:

Quality by Design (QbD) is a systematic approach to product development that emphasizes product understanding, risk mitigation, and process control to ensure increased safety and improved manufacturing quality performance. Adopting the principles of QbD could improve the manufacturing of regenerative medicine advanced therapies due to the complexity of both regenerative medicine products and the biological processes used to manufacture them. To realize the potential of QbD, the regenerative medicine community would benefit from guidance for applying these principles efficiently and effectively in gene therapy development.

SCB was invited by ARM S&T to work with them on publishing a book outlining how to apply core QbD principles to a multitude of real-world gene therapy and gene vector development and manufacturing scenarios.

PROGRESS:

Conducting Working Group Meetings: SCB is helping to coordinate meetings with the ARM-led QbD steering committee, which includes representatives from leading academic and industry organizations.

Developed Initial Outline for QbD Knowledge Book: The steering committee developed an outline for the book A-gene: Industry Book of Knowledge for the Application of Quality by Design Principles During the Manufacture of Gene Therapies and Gene Vectors.

Drafting Book Content: Committee members are currently drafting book sections, with SCB contributing technical and standards expertise to a chapter on standards.

GET ENGAGED:

SCB and ARM S&T need subject matter experts like you to help draft book sections, inform content development, and review drafts. To help, please contact SCB.