On October 3, 2022 Kite, a Gilead Company (Nasdaq: GILD), reported the U.S. Food and Drug Administration (FDA) has approved the company’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production (Press release, Kite Pharma, OCT 3, 2022, View Source [SID1234621639]). Viral vectors are key components needed to manufacture Kite’s cell therapies to treat certain blood cancers. Kite is the only cell therapy company with in-house commercial and clinical trial viral vector manufacturing capabilities, augmenting its strong external supply partners.

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CAR T-cell therapies are one-time treatments individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). During this process, a viral vector is used to encode the CAR in the patient’s T-cells so the engineered T-cells can recognize and attack the patient’s cancer cells in certain types of blood cancers. Once an individual therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Over 10,000 patients have been treated with Kite’s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 of the leading cancer hospitals in the U.S.

"The FDA approval of our commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow," said Christi Shaw, Chief Executive Officer of Kite. "This milestone is several years in the making and reflects our continued commitment to, and investment in, bringing the curative intent of cell therapy to patients."

The Oceanside site is part of Kite’s global commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam, Netherlands, and a recently FDA-approved Maryland site. This forms the largest dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. Kite has continued to increase its manufacturing network capacity to meet increasing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

"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. 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," said Chris McDonald, Global Head of Technical Operations, Kite.

The company continues to invest in its cell therapy workforce, employing approximately 100 employees at the 100,000-square-foot space. The capabilities and operations are fully scalable and will allow Kite to accommodate additional vector manufacturing as cell therapy science advances.