Advancing CQA Assessments for Gene Therapy
Time: 1:05 pm
day: Pre-Conference Workshop Day
Details:
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
