T/CITS 354-2025 Quality Control Standards for Immune Cell Therapy Products
T/CITS 354-2025
Basic Information
Scope
Scope: This document specifies the abbreviations of immune cell therapy products, the quality control of gene-modified vectors, the donor requirements for cells, materials used in production, quality control, the full process of quality control, and storage and transportation. This document is applicable to the quality control and design of immune cell therapy products. Main technical content: This document specifies the abbreviations of immune cell therapy products, the quality control of gene-modified vectors, the donor requirements for cells, materials used in production, quality control, the full process of quality control, and storage and transportation. This document is applicable to the quality control and design of immune cell therapy products.