GB/T 46490-2025
ActiveBiotechnology—Analytical methods—General requirements and considerations for the testing and characterization of cellular therapeutic products
生物技术 分析方法 细胞治疗产品的试验和表征的一般要求和考虑
Application Summary AI generated
This standard specifies general requirements and considerations for analytical methods used in testing and characterizing cellular therapeutic products. It applies to the development, validation, and quality control of cell-based therapies in biotechnology and pharmaceutical industries, ensuring consistency and reliability in evaluating product identity, purity, potency, and safety. The standard is particularly relevant for research institutions, manufacturers, and regulatory bodies involved in the production and approval of cellular therapeutic products.
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