ISCT hosted the 19th FDA CTLM on December 5 with over 65 participants, comprised of representatives from FDA/CBER/OTAT/OCOD, ISCT, AABB, ABC, ASH, ASTCT, CBA, FACT, NMDP, SITC, USP, and WMDA.
Topics covered include clarification on matrix-based approaches to potency assays and impact on expedited release and QC testing, considerations for increasing access to CB for cell therapy applications, risk-based approach to genome integrity throughout the lifecycle of gene-modified cell therapies, and development of a sustainable risk mitigation strategy.
Full meeting summary and presentations will be available in the coming weeks on the ISCT website.
#RegionalandPartnerUpdates