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Cell therapies made from a single stem cell line could be produced in bulk. Regulators should let companies certify the parent cell line once rather than repeating it for every product.
Induced pluripotent stem cell-derived CAR-NK and CAR-T products (Fate, Century, Sana, Shoreline and others) start from a clonal, gene-edited master cell bank that can in principle yield thousands of doses per run. Today each product's regulatory file repeats the characterisation of the bank (genomic stability, tumourigenicity, identity, adventitious agents). The proposal is a 'qualified master bank' status: a hypoimmune-edited iPSC bank characterised once to an agreed standard and cross-referenced by any product derived from it, with only the differentiation and CAR-specific data submitted per product.
Shares Fate Therapeutics, CAR-NK & CAR-macrophage, Allogeneic (off-the-shelf) cell therapy, Manufacturing cost and time for living and radioactive medicines.
Shares CAR-NK & CAR-macrophage, Allogeneic (off-the-shelf) cell therapy.
Shares Fate Therapeutics, CAR-NK & CAR-macrophage, Allogeneic (off-the-shelf) cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines.