2014年6月17訊 /生物谷BIOON/ --諾華（Novartis）6月16日宣布，FDA已批准霍利斯普林斯（Holly Springs）工廠生產基於細胞培養技術的流感疫苗。這是美國首個基於細胞培養的流感疫苗工廠，現已獲批進行商業化生產。該工廠將生產季節性和大流行前流感疫苗，同時具有在流感大流行發生時顯著擴大產能的能力。
諾華將利用細胞培養技術生產Flucelvax（流感病毒疫苗），這是FDA批准的首個基於細胞培養的季節性流感疫苗。Flucelvax於2012年11月獲FDA批准，用於18歲及以上成人的接種，預防季節性流感。
Flucelvax利用了大規模細胞培養生產技術，該技術是傳統蛋源性生產技術的一種替代生產方法，利用了一種特性良好的哺乳動物細胞系而非雞蛋來增殖病毒株。疫苗的生產發生在一個封閉、無菌、良好受控的環境中，顯著地降低了潛在雜質的風險。Flucelvax不含任何防腐劑，如硫柳貢或抗生素。
細胞培養技術能夠在流感大流行發生的數周內對緊急的公共健康需求快速響應。而傳統的流感疫苗生產，需要利用大量受精的雞蛋來增殖病毒，同時需要數月的時間來組織雞蛋的供應、病毒的孵育、實際生產，之後疫苗才能到達醫生或藥房。細胞培養技術已成功應用於其他疫苗的生產，如脊髓灰質炎疫苗、風疹疫苗、A型肝炎疫苗等。
Flucelvax是一種滅活疫苗，適用於由A型流感病毒和B型流感病毒所引發流感疾病的主動免疫預防。該疫苗被批准用於18歲及以上成人。
Flucelva的獲批對於諾華的流感疫苗專營權來說是一個重要的裡程碑，同時也為美國帶來了創新性的疫苗。現代細胞培養技術有望成為流感疫苗生產的新標準。（生物谷bioon.com）
英文原文：Novartis Holly Springs facility becomes first US pandemic-ready site licensed by the FDA to produce cell-culture influenza vaccines
-Cell-culture technology is a modern alternative to manufacture influenza vaccines without chicken eggs, with potential to rapidly respond to a pandemic[1]
-Flucelvax®, an FDA-approved antibiotic- and preservative-free seasonal flu vaccine, will be manufactured at this site for the US market[2]
-Licensure marks milestone in Novartis' public-private partnership to improve US capabilities to respond to seasonal epidemics and emerging public health threats
Basel, June 16, 2014 - Novartis today announced that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccines. This is the first US facility of its kind and is now approved for commercial production. The site will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic.
Novartis utilizes cell-culture technology to produce Flucelvax® (Influenza Virus Vaccine), which was the first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs[3]. Flucelvax, approved for individuals 18 years of age and older, does not contain any antibiotics or preservatives[2]. With the licensure of the Holly Springs facility, Flucelvax will be produced in the US for the first time.
"Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years. We are proud to be at the forefront of this innovation, which will allow us to deliver on our public health and health security commitments," said Andrin Oswald, Division Head, Novartis Vaccines. "With this award-winning, state-of-the-art facility, we will be able to not only offer US consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats."
Cell-culture technology offers several potential benefits over traditional influenza vaccine production, which occurs in chicken eggs. The manufacturing process can be controlled more easily and is more flexible, enabling the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic[1]. Novartis recently utilized the technology to rapidly develop a vaccine candidate for the H7N9 avian influenza virus, which was first reported in China in March 2013. This facility supplied a stockpile of H7N9 vaccine to the US Government prior to the second wave of the outbreak in January 2014.
The Holly Springs facility is a result of a joint partnership between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA). The two parties are committed to investing in innovation to better protect the public in the event of a pandemic or other health security threats. This facility was the overall winner of the ISPE Facility of the Year Award in 2013[4].
This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contracts HHSO100200600012C, HHSO100200700030C and HHSO100200900101C.