Approach to Critical Quality Attributes (CQA) Designation of Lipid Nanoparticles Enabling Gene Therapies

26 September 2022 14:20 - 14:50

  • Critical Quality Attributes
  • Approach to CQA and Criticality Roadmap
  • Quality Attributes Classification
  • Assessment Rubric
  • CQA Assessment Process Flow
  • Example Criticality Assessment

Keeth Jain, Associate Director, Drug Product Tech Transfer, Generation Bio