Advancing CQA Assessments for Gene Therapy

Time: 1:05 pm
day: Pre-Conference Workshop Day


Ensuring that novel CQAs (Critical Quality Attributes) for gene therapies are addressed is pivotal in ensuring the safety, efficacy, and consistency of emerging products. This workshop will take a look at some of the less conventional CQAs and assess their relative importance when planning an early analytical strategy.

This workshop will set out to include:

  • An introduction to novel characterisation data on AAV mutation studies
  • Analysis of real-world case studies highlighting successful applications of advanced CQA assessments
  • Discussion of challenges faced during CQA assessments and strategies to overcome them
  • Understanding regulatory requirements and compliance considerations for CQA assessments in gene therapy
  • Brainstorming alternative analytical approaches to CQA assessment for collaborative problem-solving