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Personalised cancer vaccines and cell therapies need a manufacturing run for each patient, and universities cannot afford their own plants. Regional closed, automated, modular GMP facilities offering slots to academic trials at cost, with common release testing and a shared quality system, modelled on the UK Cell and Gene Therapy Catapult centre, would let academic groups run these trials.
Regional facilities with closed, automated, modular manufacturing (mRNA and peptide neoantigen vaccines, autologous CAR-T and TIL, dendritic cell products) offering slots to academic trials at cost, with common release testing, digital batch records and a shared quality management system accepted by regulators. Modelled on the UK's Cell and Gene Therapy Catapult manufacturing centre and CIRM's Alpha Clinics, but explicitly for oncology personalised therapies where academic groups hold the biology but cannot manufacture. Coupled with the hospital-exemption registry and public CAR-T network, this is the manufacturing layer of an academic personalised-therapy system.
Shares Regional translational institutes with academic GMP suites and IND teams, Hospital-based CAR-T manufacturing at cost through a public network, TIL therapy, The valley of death between lab and product.
Shares TIL therapy, The valley of death between lab and product, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares TIL therapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares TIL therapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares TIL therapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares TIL therapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Regional translational institutes with academic GMP suites and IND teams, The valley of death between lab and product.
Shares TIL therapy, Personalised neoantigen (mRNA) vaccines.