{"id":691234,"date":"2022-10-03T09:05:04","date_gmt":"2022-10-03T13:05:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/kite-receives-u-s-fda-approval-of-viral-vector-manufacturing-facility-in-southern-california-to-produce-commercial-product\/"},"modified":"2022-10-03T09:05:04","modified_gmt":"2022-10-03T13:05:04","slug":"kite-receives-u-s-fda-approval-of-viral-vector-manufacturing-facility-in-southern-california-to-produce-commercial-product","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/kite-receives-u-s-fda-approval-of-viral-vector-manufacturing-facility-in-southern-california-to-produce-commercial-product\/","title":{"rendered":"Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product"},"content":{"rendered":"

<\/p>\n

Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product<\/b><\/p>\n

— Viral Vector Facility Further Strengthens Vertical Integration of Kite\u2019s Global CAR T-cell Therapy Manufacturing Network, Supports Growing Demand of Company\u2019s Blood Cancer Treatments —<\/i><\/b><\/p>\n

— Kite is the Only Cell Therapy Company with In-House Viral Vector Manufacturing Capabilities for Both Commercial Products and Clinical Trials —<\/i><\/b><\/p>\n

— In-house Viral Vector Supply Supports Continued Reliable Delivery of Kite\u2019s CAR T-cell Therapy Products —<\/i><\/b><\/p>\n

SANTA MONICA, Calif.–(BUSINESS WIRE<\/a>)–
\nKite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved the company’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production. Viral vectors are key components needed to manufacture Kite\u2019s 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.\n<\/p>\n

\nCAR T-cell therapies are one-time treatments individually made starting from a patient\u2019s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite\u2019s 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\u2019s T-cells so the engineered T-cells can recognize and attack the patient\u2019s 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\u2019s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 of the leading cancer hospitals<\/a> in the U.S.\n<\/p>\n

\n\u201cThe 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,\u201d said Christi Shaw, Chief Executive Officer of Kite. \u201cThis 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.\u201d\n<\/p>\n

\nThe Oceanside site is part of Kite\u2019s 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.\n<\/p>\n

\n\u201cThe cell therapy manufacturing process is complex and requires specific materials, including viral vectors that play a critical role in \u2018engineering\u2019 a patient\u2019s 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,\u201d said Chris McDonald, Global Head of Technical Operations, Kite.\n<\/p>\n

\nThe 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.\n<\/p>\n

\nFor more information on how cell therapy is manufactured, including the use of viral vectors, please click here<\/a>.\n<\/p>\n

About Kite
\n
<\/span>Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite\u2019s 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<\/a>.\n<\/p>\n

About Gilead Sciences
\n
<\/span>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.\n<\/p>\n

Forward-Looking Statements
\n
<\/span>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\u2019s 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\u2019s 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\u2019s 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\u2019s 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.\n<\/p>\n

Kite, the Kite logo, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies<\/i>.<\/i><\/p>\n

For more information on Kite, please visit the company\u2019s website at www.kitepharma.com<\/a>. Follow Kite on social media on Facebook<\/a>, Twitter (@KitePharma<\/a>), LinkedIn<\/a> and YouTube<\/a>.<\/i><\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20221003005550\/en\/<\/a><\/span><\/p>\n

\nJacquie Ross, Investors
\n
investor_relations@gilead.com<\/a><\/p>\n

\nTracy Rossin, Media
\n
trossin@kitepharma.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America California<\/p>\n

INDUSTRY KEYWORDS:<\/b> Oncology Health FDA Hospitals Genetics Pharmaceutical Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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\u2019s Global CAR T-cell Therapy Manufacturing Network, Supports Growing Demand of Company\u2019s Blood Cancer Treatments — — Kite is the Only Cell Therapy Company with In-House Viral Vector Manufacturing Capabilities for Both Commercial Products and Clinical Trials — — In-house Viral Vector Supply Supports Continued Reliable Delivery of Kite\u2019s CAR T-cell Therapy Products — SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved the company’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production. Viral vectors are key components needed … <\/p>\n

Continue reading “Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-691234","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nKite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/kite-receives-u-s-fda-approval-of-viral-vector-manufacturing-facility-in-southern-california-to-produce-commercial-product\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kite Receives U.S. FDA Approval of Viral Vector Manufacturing Facility in Southern California to Produce Commercial Product - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"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\u2019s Global CAR T-cell Therapy Manufacturing Network, Supports Growing Demand of Company\u2019s Blood Cancer Treatments — — Kite is the Only Cell Therapy Company with In-House Viral Vector Manufacturing Capabilities for Both Commercial Products and Clinical Trials — — In-house Viral Vector Supply Supports Continued Reliable Delivery of Kite\u2019s CAR T-cell Therapy Products — SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved the company’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production. 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