Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product - Seite 2
“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.
For more information on how cell therapy is manufactured, including the use of viral vectors, please click here.
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and
Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has more approved CAR T indications to help more patients than any other
company. For more information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades,
with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis
and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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Forward-Looking Statements
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 June 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those
referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that
any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements.
All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking
statements.