OnCo
termsTerm

Vein-to-vein time and manufacturing slots

aka vein-to-vein, vein to vein, manufacturing time, manufacturing slot, manufacturing slots, turnaround time, manufacturing failure, out-of-specification, OOS product, slot allocation, chain of identity, chain of custody, cryopreserved product, fresh product

For CAR-T, the number of days from collecting the patient's cells to infusing the finished product, typically three to six weeks. Every day counts when the disease is aggressive, and manufacturing capacity (slots) limits how many patients can be treated.

Vein-to-vein time includes shipping, manufacturing (transduction, expansion, release testing), cryopreservation and scheduling; commercial products average 3-4 weeks in the US and longer in Europe. Delays force bridging therapy and cost lives, which is the motivation for rapid manufacturing platforms (T-Charge, 2-day processes), point-of-care and closed automated manufacturing, in vivo CAR-T and allogeneic products. Slots are allocated per centre and per month, out-of-specification products may still be infused under expanded access, and chain-of-identity software tracks each patient's cells. In ZUMA-7 the median vein-to-vein time of about 4 weeks versus 52 days in another trial was cited as a reason for different outcomes.

Category
Treatment jargon

Connected

8top