标准编号：ISO 20399:2022
中文名称：生物技术 细胞治疗产品和基因治疗产品生产过程中存在的辅助材料
英文名称：Biotechnology — Ancillary materials present during the production of cellular therapeutic products and gene therapy products
发布日期：2022-12
标准范围
This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use. This document is applicable to materials that are used for cell processing and that come into contact with the active substance and that do not intentionally form part of the final cell and gene therapy product. EXAMPLE 1 Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human or bovine), buffered solutions, culture media, dishes (coated with biological material), beads (coated with biological material), cryoprotectants (agents for cryopreservation), activation agents/reagents, non-mammalian cell (e.g. insect cell, bacterial cell), plasmid, viral vector.
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