Technical Tuesday: Implementing QbD for Gene Therapy
11 Oct 2022
5.30-6.30pm SGT | Online
Key points:
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Gene therapy overview and market trend
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Regulatory (CMC) challenges for gene therapy products
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Quality-by-Design: Regulatory requirement and high-level framework
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Implementing QbD for gene therapy products (AAV example):
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Current industry platform manufacturing methods
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Considerations for Critical Quality Attributes, Critical Process Parameters and Material Attributes
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Considerations for Control and Testing Strategies
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Led by:
Peiqing Zhang, Strategic Technology Partnership Leader Cell and Gene Therapy, APAC, Pall Corporation, Singapore