Navigating the Ongoing Challenges of Potency Assays in Gene Therapy for Regulatory Alignment & Enhanced Validation
Time: 1:00 pm
day: Pre-Conference Assay Development Track A - PM
Details:
The complexities surrounding potency testing, from early-stage assay workarounds to long-term validation in compliance with evolving regulatory requirements, continue to be a significant hurdle for the industry, and this workshop will provide insights into overcoming these challenges while aligning with best practices.
Clarifying Potency Assay Purpose & Misconceptions: Delve into the recurring misunderstandings about potency testing, and the true purpose of potency assays in ensuring lot-to-lot consistency
Early-Stage Assay Challenges & Workarounds: Examine how early-stage gene therapy programmes navigate the lack of fully validated potency assays by utilising a combination of functional and binding assays to maintain product release standards
Long-Term Potency Validation & Regulatory Alignment: Discuss the complexities of validating potency assays throughout the gene therapy lifecycle, balancing scientific consistency with regulatory requirements to ensure clinical efficacy is meaningfully linked to assay results
