Kite Pharma Gets FDA OK for Retroviral Vector Manufacturing Facility
Gilead Sciences’ Kite Pharma has received FDA’s approval for its retroviral vector manufacturing facility in Oceanside, Calif.
Viral vectors, which deliver genetic material into cells, are needed to manufacture the company’s cell therapies to treat certain blood cancers. Kite says it is the only cell therapy company with in-house commercial and clinical trial viral vector manufacturing capabilities.
The company intends to use the facility to focus on a crucial element in developing chimeric antigen receptor (CAR) T-cell therapy, which uses a part of a patient’s T cells, modified with a viral vector to enable the cells to attack cancer cells.
The viral vector production will support the delivery of CAR T-cell therapy on a large commercial scale as well as providing supply for clinical trials to develop future treatments, the company said.