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There is no agreed ruler for measuring how strong a CAR-T product is. Shared reference materials would let hospitals, companies and regulators compare products fairly.
How strongly a CAR-T batch kills its target cells is the release attribute regulators worry about most for cell therapies, and every developer measures it with a different in-house assay, making comparability, decentralised manufacturing and biosimilar-like competition impossible. The proposal is a programme, led by a metrology institute such as NIST or NIBSC with the ISCT and regulators, to produce certified reference CAR-T cell materials, reference target cells and standardised cytotoxicity and cytokine assays with published acceptance criteria, made available at cost.
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.