“We spend a great deal of time with the hospitals.
To manufacture and administer autologous CAR T therapies, T cells need to be taken from a patient at specialised sites via apheresis, proliferated at what is usually a centralised manufacturing facility, then returned and administered into the patient within a very short and precise timeline.Īnd for a successful product, the apheresis sites have to be maintained and operated in a uniform manner, Curry said, as do the numerous administrative clinics.Įducation, Accreditation, Administrationīack in October, a Gilead spokesperson told Biopharma-Reporter the firm is working to certify 16 clinics in 13 states for Yescarta, but an ultimately hopes to have 70 to 90 certified academic centers. On the positive side, the supply chain can be shorter with fewer steps, but you have a lot more responsibility all the way from the beginning to the end.” “But for cell therapies it’s quite different.
KITE PHARMA AMSTERDAM FREE
Pharma companies are not so involved with the therapy at that point out in the medical field they sell the vials and then they are pretty much free from oversight,” he told delegates. “Those unit operations are very segregated, time-based, and take months to move from one place to another. The process takes an average of 17 days from receipt of the patient’s white blood cells. Once there are a sufficient number of cells available for infusion back into the patient, they are washed and frozen at the cell processing site before being shipped back to the clinical centre where they can be administered to the patient. These are then sent to a facility in El Segundo, California – which Kite opened in June last year – where they are stimulated to proliferate and transduced with a retroviral vector to introduce the CAR sequence into the patient’s T cells before being propagated in cell culture bags.
The product is made by isolating peripheral blood mononuclear cells, including T-cells, from the patient’s own white blood cells.
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