US FDA Approved Kite’s Viral Vector Manufacturing Facility to Produce Commercial Product


Kite, a Gilead Company, announced the retroviral vector (RVV) manufacturing facility of the company in California, has received the US Food and Drug Administration (FDA) approval  for commercial production.

Viral vectors are important components needed to manufactures cell therapies of Kite to treat certain types of blood cancers. Kite is the only cell therapy company that has in-house commercial and clinical trial vector production capabilities, augmenting the company’s strong external supply partners.

CAR T-cell therapies are the one-time treatments made individually starting from own white blood cells (WBCs) or T-cells of patients. The cells are mainly removed through a process that is similar to donating blood and are sent to the specialized manufacturing facilities of Kite, where the cells are modified with a Chimeric Antigen Receptor (CAR).

Christi Shaw, chief executive officer of Kite, said that the US FDA approval of their commercial viral vector manufacturing facility further strengthens their global cell therapy production network with addition of an in-house capability to manufacture a crucial element in the CAR T process that is important as patient demand continues to grow.

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Christi Shaw added that this achievement reflects their commitment and investment for bringing curative intent of the cell therapy to the patients.