New
White Paper

A key aspect of Chemistry Manufacturing and Controls (CMC) documentation for complex biological products is the application of Quality by Design (QbD) principles: A rationale of quality being achieved by process design rather than relying on final quality testing alone. The work presented here provides a framework to illustrate the concept and initial thoughts on using QbD concepts for gene therapy, specifically Adeno-Associated Virus (AAV) production.

A risk- and science-based QbD assessment for AAV was conducted by evaluating the following: 

• Quality Target Product Profile (QTPP)
• Critical Quality Attributes (CQAs)
• Critical Process Parameters (CPPs)
• The design space and control strategy