WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics
WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics
WUXI and SUZHOU, China, Aug. 1, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that four manufacturing facilities and Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA), demonstrating the company's commitment to meeting rigorous international industry quality standards across its global network.
2024年8月1日，中國無錫和蘇州/美通社/--藥明生物（“WuXi Bio”）（2269.HK）是一家領先的全球合同研究、開發和製造組織（CRDMO），今日宣佈，其中國的四家生產設施和蘇州生物安全測試中心已獲得歐洲藥品管理局（EMA）的良好生產規範（GMP）認證，展示了公司致力於滿足全球網絡中嚴格的國際行業質量標準的承諾。
Following comprehensive inspections of the company's facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company's capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company's Suzhou Biosafety Testing Center was once again certified by the EMA to provide services for ten novel therapies, including the eight biologics being manufactured in Wuxi.
在對公司設施進行全面檢查後，特別是無錫市的MFG1，MFG2，MFG5和DP1 ，EMA GMP證書已爲在製藥生產和服務的八種生物製品頒發，這是對公司在爲全球客戶提供此類服務的能力的認可。所有這些設施之前都已獲得EMA和其他主要監管機構的批准，用於開發多種生物療法。此外，該公司的蘇州生物安全測試中心再次獲得EMA認證，以爲包括在無錫製造的八種生物製品在內的十種新療法提供服務。
WuXi Biologics has a proven track record of strict quality compliance. Since 2017, the company has completed and passed 35 global regulatory agency inspections, more than 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons. Currently, WuXi Biologics has 15 GMP-certified drug substance and drug product facilities in its global network.
藥明生物證明了其嚴格的質量合規記錄。自2017年以來，公司已完成並通過了35次全球監管機構的檢查，全球客戶進行了超過1,250次 GMP質量審計，並進行了145次歐盟合格人員審核。目前，藥明生物在其全球網絡中擁有15個GMP認證藥物物質和藥物產品設施。
Dr. Chris Chen, CEO of WuXi Biologics, commented: "We are proud that our facilities have once again been certified by the EMA, reflecting our unwavering commitment to the highest quality standards across the company. Quality audits are crucial to ensuring the safety and efficacy of the global pharmaceutical industry, and WuXi Biologics remains dedicated to enabling our clients in bringing high-quality biologics to patients worldwide."
藥明生物首席執行官陳永康博士評論說：“我們爲我們的設施再次被EMA認證感到自豪，這反映了我們對公司全面質量標準的不懈承諾。質量審計對於確保全球製藥行業的安全性和療效至關重要，藥明生物致力於使客戶能夠爲全球患者提供高質量的生物製品。”
About WuXi Biologics
關於藥明生物
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
藥明生物（2269.HK）是一家領先的全球合同研究、開發及製造組織（CRDMO），提供端到端的解決方案，使合作伙伴能夠從概念到商業化研製和製造生物製品，造福世界各地的患者。
With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2023, WuXi Biologics is supporting 698 integrated client projects, including 24 in commercial manufacturing.
藥明生物在中國、美國、愛爾蘭、德國和新加坡擁有超過12,000名技術熟練的員工，利用其技術和專業知識，爲客戶提供高效、經濟的生物製品研發和製造解決方案。截至2023年12月31日，藥明生物正在支持698個結合式客戶項目，其中24個爲商業製造項目。
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to be an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
藥明生物將環境、社會和治理（ESG）責任視爲其道德和業務戰略的一個組成部分，並旨在成爲生物製品CRDMO行業的ESG領導者。我們的設施使用下一代生物製造技術和清潔能源。同時成立了一個ESG委員會，由我們的CEO領導，以指導綜合的ESG戰略及其實施，加強我們對可持續性的承諾。
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SOURCE WuXi Biologics
來源：藥明生物
譯文內容由第三人軟體翻譯。