Hospital-made CAR-T under one shared regulatory master file
Instead of shipping a patient's cells to a distant factory, hospitals would make CAR-T on site under a shared licence, cutting cost and waiting time.
Academic point-of-care CAR-T already exists: ARI-0001 (Hospital Clinic Barcelona, approved under Spain's hospital exemption at roughly a third of commercial cost), NexCAR19 in India (ImmunoACT, list price around $40,000) and several Chinese and Israeli programmes. The MHRA's 2025 framework for point-of-care and modular manufacturing allows one authorisation to cover multiple hospital sites under a central control site. The proposal is a network of 20-30 hospital GMP suites making a common CD19 (and later BCMA) product from a shared master file, with pooled release testing data and a single outcomes registry.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
Pages like this
not linked directly; found by shared links- IdeaHospital-based CAR-T manufacturing at cost through a public network
Shares BCMA, CD19, Prices and value, Manufacturing cost and time for living and radioactive medicines.
- IdeaPlan the second CAR-T target before the first one is lost
Shares BCMA, CD19, Manufacturing cost and time for living and radioactive medicines, Multiple myeloma.
- IdeaNon-profit, open-licence lentiviral vectors and producer cell lines for CAR-T
Shares BCMA, CD19, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaCollect and freeze T cells at diagnosis for high-risk patients, before chemotherapy
Shares Manufacturing cost and time for living and radioactive medicines, Multiple myeloma, Diffuse large B-cell lymphoma, CAR-T cell therapy.
- IdeaIn vivo CAR-T manufactured and priced like a generic biologic
Shares BCMA, CD19, Prices and value, Manufacturing cost and time for living and radioactive medicines.
- InstitutionHadassah Medical Center
Shares BCMA, CD19, Manufacturing cost and time for living and radioactive medicines, Multiple myeloma.
- IdeaNon-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route
Shares CD19, Manufacturing cost and time for living and radioactive medicines, Diffuse large B-cell lymphoma, CAR-T cell therapy.
- IdeaHarmonise Europe's hospital exemption for academic cell therapies, with one registry
Shares Manufacturing cost and time for living and radioactive medicines, Multiple myeloma, Acute lymphoblastic leukaemia, CAR-T cell therapy.