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On October 13, 2021, the National Group Information Platform released the group standard of "Autologous CAR-T Cell Drug Supply Chain Management Regulations" (T/SHPPA 011—2021) drafted by Shanghai Pharmaceutical Industry Association and Shanghai Drug Evaluation and Verification Center.
, The standard will be implemented on October 18, 2021
.
This "Regulations for the Management of Autologous CAR-T Cell Drug Supply Chain" group standards stipulates the management requirements of the autologous CAR-T cell drug supply chain, including the responsibilities of MAH and related parties in the autologous CAR-T cell drug supply chain, digital information platforms, and facilities Equipment, logistics operations, transportation of donor materials and autologous CAR-T cell medicines, storage of autologous CAR-T cell medicines, delivery of autologous CAR-T cell medicines, handling of abnormal situations, recalls, disposal of non-conforming products, document records, etc.
1.
How much do you know about autologous CAR-T cell drugs?
How much do you know about autologous CAR-T cell drugs?
CAT-T cells, or chimeric antigen receptor T cells, use genetic modification technology to transfer genetic material with specific antigen recognition domains and T cell activation signals into T cells, allowing T cells to directly interact with tumor cells on the surface It is activated by combining with specific antigens, and directly kills tumor cells by releasing perforin, granzyme B, etc.
, and at the same time recruiting human endogenous immune cells to kill tumor cells by releasing cytokines, so as to achieve T cells for the purpose of treating tumors
.
Gene therapy products used to be just a theory.
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references
[1] Shanghai Pharmaceutical
