Regulatory insights on adeno-associated virus-based gene therapies, cell- and tissue-based products, and CAR-T cell therapies: report from the 8th Asia Partnership Conference of Regenerative Medicine, April 24, 2025.

ABSTRACT: The 8th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in a hybrid format-both in person and online-on April 24, 2025, to advance regulatory harmonization for regenerative medicine products across Asia. Understanding the domestic regulatory guidelines and their underlying rationales within each country and region represents a crucial first step toward achieving harmonized regulation. The 8th APACRM featured open discussions and case study presentations addressing the Quality by Design (QbD) approach in gene therapy manufacturing, non-clinical evaluation of adeno-associated virus (AAV)-based gene therapy products, the product lifecycle and regulatory landscape of AAV gene therapies, and post-launch regulatory requirements for regenerative medical products. The progra

SUBMITTER: Tominaga S 

PROVIDER: S-EPMC12925219 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature