FIRM awarded the first FIRM Mark Certification on the 20th of May, 2024.
Applicable Standards: ISO 20399:2022 Biotechnology-General Requirements for Supplemental Materials Used in the Manufacturing of Cellular Therapy Products and Genetic Therapy Products
Certification Scheme: FMC-61 FIRM Mark Manufacturing Assistance Materials (reagents/culture media, etc.) Certification Scheme
Product：R:STEM Medium for hMSC High Growth（Serum-free AOF Medium for Mesenchymal Stem Cells、ROHTO Pharmaceutical Co., Ltd.）
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What is FIRM Mark Certification?
This is a certification system for products and services in the regenerative medicine-supporting industries established by FIRM. That is, a system in which FIRM recognizes that products and services in the regenerative medicine-supporting industries meet the requirements of the standards, as a third party, that is, a certification body, and allows companies with certified products and services to use FIRM marks.
What is ISO 20399:2022 on “Biotechnology-General Requirements for Supplemental Materials Used in the Manufacturing of Cell Therapy Products and Gene Therapy Products” ?
An international standard issued by the International Organization for Standardization in 2022 for auxiliary materials, i.e., materials that contact cell therapy products and gene therapy products at the time of production but are not intended to be part of the final product formulation. This standard is a document that provides guidance for supplementary materials such as reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human and bovine), buffer, and culture media. For suppliers, guidance on infomation for users. For users, guidance mainly on material selection and qualification.
What is “Certification Scheme for FIRM Marker Manufacturing Supplements (Reagents, Culture medium, etc.)?
This document describes a certification scheme for FIRM to apply ISO 20399:2022 to certify production auxiliaries, which is a set of procedures that defines how to conduct certification, requirements, and certification assessments.