Quality by Design (QbD)
of Adeno-Associated Virus
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
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