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藥明生基全新生產基地投入運營,進一步為全球客戶提供CTDMO


發布時間:2021-10-18 藥融圈
注:本文不構成任何投資意見和建議,以官方/公司公告為準;本文僅作醫療健康相關藥物介紹,非治療方案推薦(若涉及)。因水平有限,錯誤不可避免,或有些信息非最及時,歡迎留言指出。

 

 

藥明生基全新生產基地投入運營,進一步為全球客戶提供CTDMO一體化服務


中國上海,2021年10月18日 -- 藥明康德旗下專注于細胞和基因療法的CTDMO藥明生基今日宣布,公司在上海臨港新建的工藝研發和商業化生產中心正式投入運營。作為藥明生基全球第四個生產基地,該中心將有力補充公司的全球化運營網絡,并與美國、英國和中國的其他三個基地聯動,通過強大的產能布局為全球客戶提供更高效的服務。

投入運營后,臨港基地將為病毒載體和細胞療法提供一體化的工藝開發、生產和測試服務。新基地配備200多個獨立套間和6條完整的載體和細胞生產線,包含獨立的配液中心和GMP級別無菌灌裝隔離器。這些設施將進一步增強藥明生基的全球化產能,從而在病毒載體和細胞療法服務方面為客戶提供更大的靈活性和更快的交付時間。


去年,藥明生基完成了美國費城細胞及基因療法生產基地的擴建,將高端檢測產能提升了三倍。此次新建臨港基地是藥明生基全球化平臺建設的又一重要舉措,通過不斷建能力、擴規模,持續為全球客戶提供高質量的解決方案。


 “細胞及基因療法在幫助預防、治療許多重癥及罕見病方面起到了至關重要的作用,這也是藥明生基不斷拓展細胞及基因療法服務平臺的初衷。”藥明生基首席執行官張幼翔博士表示:“通過擴大全球運營網絡,我們將進一步提升藥明生基CTDMO服務平臺的能力和規模,賦能全球客戶為患者帶來更高效、可及的先進療法。”


作為一個全球化運營的CTDMO,藥明生基獨特的商業模式將強大的測試能力與工藝開發及生產平臺能力緊密結合,如用于腺相關病毒(AAV)生產的新型TESSA技術和用于慢病毒穩定生產的XLenti解決方案等。通過藥明生基的一體化賦能平臺,所有的檢測開發、生物安全、病毒清除和最終產品放行檢測等環節都能在這個平臺上得以實現,幫助客戶大幅縮短先進療法的上市周期。

關于藥明生基

藥明生基是藥明康德旗下專注于細胞和基因療法的CTDMO,致力于加速和變革細胞治療、基因治療及其他高端治療的開發、測試、制造和商業化。藥明生基能夠助力全球客戶將更多創新療法早日推向市場,造福病患。更多信息,請訪問www.advancedtherapies.com。

關于藥明康德

藥明康德(股票代碼:603259.SH/2359.HK)為全球生物醫藥行業提供一體化、端到端的新藥研發和生產服務,在亞洲、歐洲、北美等地均設有運營基地。藥明康德通過獨創的“CRDMO”和“CTDMO”業務模式,不斷降低研發門檻,助力客戶提升研發效率,為患者帶來更多突破性的治療方案,服務范圍涵蓋化學藥研發和生產、生物學研究、臨床前測試和臨床試驗研發、細胞及基因療法研發、測試和生產等領域。2021年,藥明康德被MSCI評為ESG(環境、社會及管治)AA級。目前,公司的賦能平臺正承載著來自全球30多個國家的5200多家合作伙伴的研發創新項目,致力于將更多新藥、好藥帶給全球病患,早日實現“讓天下沒有難做的藥,難治的病”的愿景。更多信息,請訪問公司網站:www.wuxiapptec.com


WuXi ATU Opens New Manufacturing Facility to Further Enhance Its CTDMO Services for Global Customers 

Philadelphia, 17 October 2021 - WuXi Advanced Therapies Inc. (WuXi ATU) – a wholly owned subsidiary of WuXi AppTec – today announced the opening of its new process development and commercial manufacturing facility in Lin-gang, Shanghai. WuXi ATU is a leading Contract, Testing, Development and Manufacturing Organization (CTDMO) headquartered in Philadelphia. As its fourth manufacturing site worldwide, the new facility will supplement WuXi ATU’s global footprint and will further join with other sites in the United States, United Kingdom and China to enable global customers with enhanced capacity and efficient services.


 

The Lin-gang facility offers integrated development, manufacturing, and testing services for viral vectors and cell therapies. It contains more than 200 independent suites and six complete production lines, including an independent liquid distribution center and independent GMP standard sterile filling isolator. These resources will strengthen WuXi ATU’s operations worldwide, offering customers greater flexibility and speed in the delivery of viral vectors and cell therapies.


The Lin-gang facility’s opening follows a major expansion of WuXi ATU’s Philadelphia Navy Yard campus in 2020 that tripled its advanced testing capacity and provided much needed services for clients globally.


“Cell and gene therapies play a critical role in helping treat and prevent many severe and rare diseases, which is why WuXi ATU is committed to growing our comprehensive one-stop service platform specifically dedicated to the gene and cell therapy field,” said Dr. David Chang, Chief Executive Officer of WuXi ATU. “By expanding our global footprint, we will provide enhanced cell and gene therapy manufacturing services for our customers worldwide and better enable them to deliver more effective and accessible advanced therapies to patients.” 

 


As a CTDMO with operations globally, WuXi ATU’s unique business model integrates powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, so that all assay development, biosafety, viral clearance and product release testing can be carried out in house, enabling customers to shorten the timeline for the approval of advanced therapies.
 

About WuXi Advanced Therapies
(WuXi ATU)
 

As the wholly owned subsidiary of WuXi AppTec, WuXi ATU is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.

For more information, please visit www.advancedtherapies.com.
 

About WuXi AppTec
 

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,200 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com

 

 

 

 

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