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CAR-T can now be made in a day or two, but the safety tests to release it still take two weeks. Faster tests would let patients be treated within days.
Non-expanded or minimally expanded CAR-T processes (Novartis T-Charge and rapcabtagene autoleucel, several academic protocols) produce a product in 24-48 hours, but release still waits for compendial 14-day sterility, mycoplasma and vector copy number assays. The proposal is a regulatory pathway for rapid release: validated rapid microbial methods (PCR- or growth-based, 24-72 hours), qPCR mycoplasma, flow-based potency surrogates, and 'release-then-confirm' with infusion permitted after rapid tests and compendial tests completed in parallel, as is already accepted for some cord blood and radiopharmaceutical products.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.