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Hospital-based CAR-T manufacturing at cost through a public network

Academic hospitals can already make CAR-T cells for a fraction of the commercial price. A public network would scale that so more patients can be treated for less.

Point-of-care manufacturing of CAR-T and other autologous cell therapies in a network of accredited academic hospitals, using shared vectors, harmonised processes and closed automated systems, with regulatory approval as a hospital-exemption or public product rather than a commercial licence. Spain's ARI-0001 (Hospital Clínic Barcelona) was approved by the national agency as a hospital-made CD19 CAR-T at a reported cost far below commercial products; India and Brazil have followed with domestic academic products. A network would share process, quality and pharmacovigilance and could supply public health systems at cost.

Hypothesis
A ten-hospital public CAR-T network delivers CD19 and BCMA CAR-T with efficacy and safety non-inferior to commercial products in registry comparison, at a fully-loaded cost per treated patient under a third of commercial list prices, and doubles the number of eligible patients treated in its regions within four years.
Rationale
ARI-0001 and academic products elsewhere demonstrate feasibility and regulatory acceptance; academic manufacturing removes the margin and much of the logistics cost. Capacity, not biology, currently rations CAR-T in most of the world.
What would test it
Fund a five-centre pilot with a shared vector and process, register a prospective comparative registry against commercial products, and report outcomes and cost at three years.
Maturity
early clinical
Who has to act
clinic
Cost to try
Large (over $50M)
Years to first evidence
4
Bottlenecks it attacks

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