Comparison of guidelines for biological ancillary materials used for the manufacture of gene and cellular therapy products in Asia

Author:

Tanaka Toshimitsu,Yoshimura Keiji,Chang Ryan,Choi Bryan,Gai Ying,Gupta Pawan Kumar,Kolkundkar Udaykumar,Lee Shing-Mou,Lee Sunray,Liao Wenbin,Zhao Xiang,Takakura Koji

Funder

Food Institutional Research Measure

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference46 articles.

1. Gaps between Asian regulations for eligibility of human mesenchymal stromal cells as starting materials of cell therapy products and comparability of mesenchymal stromal cell-based products subject to changes in their manufacturing process;Tanaka;Regen Ther,2020

2. Nonclinical and quality assessment of cell therapy products: Report on the 4th Asia Partnership Conference of Regenerative Medicine, April 15, 2021;Yoneda,2022

3. United States Pharmacopoeia. 1043: Ancillary materials for cell, gene, and tissue-engineered products.

4. ISO/TS 20399-1: 2018. Biotechnology—Ancillary materials present during the production of cellular therapeutic products - Part1: General requirements

5. ISO/TS 20399-2: 2018. Biotechnology—Ancillary materials present during the production of cellular therapeutic products – Part2: Best practice guidance for ancillary material suppliers

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