Business
Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland
-- Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies -- Scalable and
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies\n\n-- Scalable and Adaptable Facility Provides Flexibility for Current and Future Cell Therapy Innovation\n\n SANTA MONICA, Calif.--(BUSINESS WIRE)--\nKite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.\n\nThe Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands to form the largest, dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. With today’s announcement, and through a variety of optimization efforts across Kite’s global CAR T-cell therapy manufacturing network, Kite estimates network capacity will be increased by 50%, enabling more patients to be served now and in the future.\n\n“The FDA approval of our Maryland site marks an important milestone within our global CAR T-cell therapy manufacturing network, and will enable us to significantly expand our production capacity and further strengthen our ability to meet the needs of people living with difficult-to-treat blood cancers,” said Christi Shaw, Chief Executive Officer of Kite. “Manufacturing is central to every decision we make at Kite. Our teams hold patients’ cells in their hands every day, which could mean the difference between getting a chance to live or possibly losing their battle with cancer. It must be fast and extremely high quality to give patients the best outcome.”\n\nCAR T-cell therapies are individually manufactured for each patient using their own T-cells extracted from their white blood cells. The patient’s T-cells are sent to Kite’s manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR) to recognize, attack and destroy their cancer cells. Once the individualized 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. Unlike most cancer treatments, CAR T-cell thera...