A-Gene Case Study: QbD Principles in Gene Therapy CMC

Published on Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine’s A-Gene initiative demonstrates how Quality by Design (QbD) can be embedded into gene therapy CMC programs. The project highlights practical case studies where structured design and risk-based approaches enhance product quality, streamline manufacturing, and improve regulatory alignment for advanced therapies.

👉 Read the full article: A-Gene Case Study

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