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中国,上海
2022年11月21日
全球领先的合同研究、开发和生产(CRDMO)服务公司药明生物(WuXi Biologics, 2269.HK)宣布,其位于上海市奉贤区的一体化生物药CRDMO服务中心正式开业。该中心将新增端到端开发和生产服务能力,为多元化生物药提供从工艺开发到临床原液和制剂生产的一站式服务。这也是药明生物在中国运营的第九个基地。

药明生物上海奉贤一体化生物药CRDMO服务中心总面积达15万平方米,于2018年11月启动建设。其中部分已于2020年启用,不仅为全球客户提供包括靶点评价、试剂制备、抗体生成、先导生物药优化、复杂生物药发现、临床前候选药物(PCC)选择和新药临床试验申请(IND)候选药物选择的全方位研究服务,还提供工艺开发、分析开发及制剂开发服务,加速全球客户产品研发进程。该中心还配备药明生物具有自主知识产权的WuXiBody®和SDarBody™技术平台,为全球客户提供双特异性和多特异性抗体发现服务。
此次启用的一体化生物药CRDMO服务中心还包括生物药原液十七厂(MFG17)、生物制剂十四、十五厂(DP14,DP15),能够灵活满足全球客户各种临床阶段项目不同规模、规格从原液到制剂的一站式生产需求。这三个生产厂预计于2023年正式投入GMP生产,将进一步提升公司临床生产服务能力。
目前,逾千名药明生物员工已入驻一体化生物药CRDMO服务中心,其中硕士以上学历占70%。未来中心全面运营后,药明生物专业团队可以在同一个园区内提供从早期新药发现到后期商业化生产的全方位、端到端服务,大幅加快客户项目的交付速度。
药明生物首席执行官
陈智胜博士
“随着未满足的医疗需求不断增加,未来全球生物制药市场仍将强劲增长。药明生物上海奉贤一体化生物药CRDMO服务中心适逢其时,将更好地赋能日益增长的不同阶段的生物药。我们将不断提升业务能力和规模水平,为更多全球合作伙伴赋能,助力其产品加速商业化进程,早日造福广大病患。”
药明生物上海奉贤一体化生物药CRDMO服务中心也是公司成功践行环境、社会和公司治理 (ESG)战略的又一力证。该中心全面应用热能回收及水资源循环管理系统等绿色设计理念,以最大限度地减少对环境的影响。此外,中心已经启动屋顶光伏项目,预计每年将减少数百吨的碳排放量。
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WuXi Biologics Launches an Integrated Biologics CRDMO Center in Fengxian, Shanghai
SHANGHAI, China
November 21, 2022
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), launched its Integrated Biologics CRDMO Center located in the district of Fengxian in Shanghai. The opening will add development and manufacturing capacity at the Center, with end-to-end services for diversified biologics to accelerate global clients' project timelines – from process development, analytical development, drug product development and quality control to pilot-scale manufacturing, clinical drug substance and drug product manufacturing. This also marks WuXi Biologics' ninth operational site in China.
Construction on the 1.6 million-square-foot Integrated Biologics CRDMO Center began in November 2018. Initial phase, which became operational in 2020, provides an entire range of biologics research services from target evaluation, reagent generation, antibody generation, lead optimization, complex biologics discovery, Pre-Clinical Candidates (PCC) identification to Investigational New Drug (IND) candidate selection. It also offers proprietary technology platforms WuXiBody® and SDarBody™ for bispecific and multispecific antibodies discovery respectively.
This opening includes drug substance facility (MFG17) and two drug product facilities (DP14 and DP15) which are designed for maximum flexibility to meet global clients' demand for clinical drug substance and drug product manufacturing of their innovative biologics at various scales and volumes. These facilities will further enhance the company's clinical manufacturing network and ensure robust node of global capacity after their GMP release in 2023.
More than 1,000 employees are now working at the Integrated Biologics CRDMO Center, 70% of whom have Master's degrees or above. Once the center is completed and fully operational, it will be able to deliver any biologics project with unprecedented speed by leveraging WuXi Biologics' entire spectrum of services and expertise – from early-discovery to commercial manufacturing – all within the Center.
Dr. Chris Chen
CEO of WuXi Biologics
"The global biologics market is expected to grow strongly, driven by the mounting demand for treating medical needs. The Integrated Biologics CRDMO Center in Shanghai is well-positioned to support the growth of new biologics programs at different stages. Powered by the expanding capabilities and capacity, we look forward to supporting more partners on their paths to commercialization of these products for the benefit of patients."
As another showcase of best practices for WuXi Biologics' Environmental, Social, and Governance (ESG) strategy, the Center applies green designs such as heat recovery and water recycling systems to minimize environmental impact. A rooftop solar power program has been initiated and is expected to reduce carbon emissions by hundreds of tons every year.
About WuXi Biologics
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注:本信息不构成药明生物的信息披露或投资建议

