Continuous-flow synthesis of ultra-potent ADC payloads to ease the capacity squeeze
The poisons carried by antibody-drug conjugates are so toxic that only a few factories can make them, and they are booked years ahead. Making them in small continuous reactors would ease the bottleneck.
High-potency active pharmaceutical ingredient (HPAPI) capacity for payloads such as exatecan derivatives, maytansinoids and auristatins is concentrated in a small number of contract manufacturers with multi-year lead times, and batch handling of milligram-potency toxins requires costly containment. Continuous-flow chemistry in enclosed micro- or meso-reactors reduces the inventory of toxic intermediates at any moment, shrinks containment footprint and allows numbering-up rather than scale-up. The proposal is a pre-competitive programme to develop and regulator-qualify flow routes for the three most used payload classes and license them openly to manufacturers.
- 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.
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