With the country's emphasis on innovative drugs and new treatment technologies, as well as the development and maturity of immune cell therapy technology, the time from R&D to launch of immune cell products has gradually shortened, and more and more immune cell products have gradually entered the market. At present, the detection method of flow cytometry has been widely used in the analysis of cell phenotype and function. Its powerful analytical performance and multi-parameter characteristics make it a very important technical means for quality detection of immune cell products. In the regulatory environment of GMP, domestic and foreign regulations lack technical requirements for verification of flow cytometric detection methods for immune cell products used in quality control laboratories of pharmaceutical companies. Flow cytometry is an analysis method that is very flexible and highly dependent on the experience of the examiner, and cells from different donors have great individual differences, which has led to the verification of flow cytometry methods by various companies. The requirements are not uniform. In order to ensure the quality of flow cytometry testing of immune cell products and guide the clinical application of immune cell products in my country, stable and reliable flow cytometry testing verification technical requirements should be established to ensure the scientific nature of flow cytometry testing data. At present, immune cell therapy is mainly deployed in T cell products, such as CAR-T, TCR-T, TIL, etc., and CD3 molecules are surface antigens of mature T cells. T cells are mainly divided into helper T cells that express CD4 and killer T cells that express CD8. Therefore, in view of the different characteristics of each T cell product, in order to improve the applicability of flow cytometry verification methods, flow cytometry verification requirements for CD3, CD4 and CD8 applicable to immune cell therapy products should be established.
T/ZSA 146-2023 history
2023T/ZSA 146-2023 Technical requirements for Flow Cytometry validation of CD3、CD4、CD8 of immune cell product