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

[中文适用范围]： 本文件规定了要求并为辅助材料 (AM) 的供应商和用户提供指导，以提高用于生产人用细胞治疗产品和基因治疗产品的生物（人类和动物）和化学来源的 AM 的一致性和质量。 本文件适用于用于细胞加工并与活性物质接触且不有意构成最终细胞和基因治疗产品一部分的材料。 实施例1 试剂、抗凝剂、细胞因子、生长因子、酶、抗体、血清(人或牛)、缓冲溶液、培养基、培养皿(涂有生物材料)、珠子(涂有生物材料)、冷冻保护剂(冷冻保存剂) 、活化剂/试剂、非哺乳动物细胞（例如昆虫细胞、细菌细胞）、质粒、病毒载体。 本文件不适用于不用于细胞加工的材料、不与活性物质接触的材料或有意构成最终细胞和基因治疗产品一部分的材料。 实施例2 作为细胞治疗产品的起始材料、中间体或最终形式的细胞、饲养细胞、生物加工后使用的添加剂、支架、非生物消耗品（例如珠子、培养皿、组织培养烧瓶、袋、管、移液管、针） ）、其他与细胞或组织接触的塑料器具、装置、仪器。 附录 A 给出了决策流程图。 注：国际、地区或国家法规或要求也适用于本文件涵盖的特定主题。 [外文原描述]： 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. This document does not apply to materials that are not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product. EXAMPLE 2 Cells that are either starting materials, intermediates or final form of a cellular therapeutic product, feeder cells, additives used post bioprocessing, scaffolds, non-biological consumables (e.g. beads, dishes, tissue culture flasks, bags, tubing, pipettes, needles), other plasticware that come into contact with the cell or tissue, apparatus, instruments. A decision flowchart is given in Annex A . NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.