Technical Tuesday

Technical Tuesday: Implementing QbD for Gene Therapy 

11 Oct 2022  

5.30-6.30pm SGT | Online 


Key points:

  • Gene therapy overview and market trend

  • Regulatory (CMC) challenges for gene therapy products

  • Quality-by-Design: Regulatory requirement and high-level framework

  • Implementing QbD for gene therapy products (AAV example):

    • Current industry platform manufacturing methods

    • Considerations for Critical Quality Attributes, Critical Process Parameters and Material Attributes

    • Considerations for Control and Testing Strategies


Led by: 

Peiqing Zhang, Strategic Technology Partnership Leader Cell and Gene Therapy, APAC, Pall Corporation, Singapore