Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product
-- Viral Vector Facility Further Strengthens Vertical Integration of Kite’s Global CAR T-cell Therapy Manufacturing Network, Supports Growing Demand of Company’s Blood Cancer Treatments --
-- Kite is the
-- In-house Viral Vector Supply Supports Continued Reliable Delivery of Kite’s CAR T-cell Therapy Products --
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
“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
“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
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.
For more information on how cell therapy is manufactured, including the use of viral vectors, please click here.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Kite’s ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies or produce an amount of supply sufficient to satisfy demand for such therapies; Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all; the possibility of unfavorable results from ongoing or additional clinical trials; Kite’s ability to receive regulatory approvals in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended
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