标准编号：ISO/TS 20399-2:2018
中文名称：生物技术 细胞治疗产品生产中的辅助材料 第2部分：辅助材料供应商的最佳实践指导
英文名称：Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 2: Best practice guidance for ancillary material suppliers
发布日期：2018-11
标准范围
This document provides guidance for ancillary material (AM) suppliers to maintain a high level of
lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the
accompanying documentation.
This document is applicable to cellular therapeutic products, including gene therapy products whereby
cells form part of the final product. It does not apply to products without cells.
The AMs described in this document include those of biological origin [e.g. sera, media (including media
additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not
address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and
instruments, or additives used post bioprocessing.
This document does not cover the selection, assessment or control of starting materials and excipients.
NOTE International, regional or national regulations or requirements can also apply to specific topics
covered in this document.
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