FDA Approves Kite’s New Viral Vector Manufacturing Facility

FDA has approved Kite’s retroviral vector (RVV) manufacturing facility in Oceanside, CA, for commercial production. Viral vectors are key components that are needed to manufacture the biopharma company’s cell therapies that treat certain blood cancers. Kite, a Gilead company, offers both in-house commercial and clinical trial viral vector manufacturing capabilities.

Specifically, the 100,000 square-foot center is intended to support chimeric antigen receptor T-cell (CAR-T-cell) therapies, one-time treatments that are individually made, starting from a patient’s own white blood cells (T-cells).

“The cell therapy manufacturing process is complex and requires specific materials, including viral vectors that play a critical role in ‘engineering’ a patient’s own T-cells to recognize and attack their cancer," explains Chris McDonald, Kite’s global head of technical operations. "The certainty of timely and dependable viral vector production supplied by our own facility provides an additional level of control essential for reliably delivering CAR T-cell therapy on a large commercial scale, as well as providing supply for clinical trials to develop future treatments.”

The Oceanside site is part of Kite’s global commercial manufacturing network that features facilities in El Segundo, CA, Amsterdam, Netherlands, and a recently FDA-approved Maryland site.