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满足不同阶段项目的多样化生物制剂灌装需求，尤其是临床后期和商业化阶段项目
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提升生物制剂商业化生产服务能力，每年新增至多达6000万瓶产能
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应用一次性生产和自动化等创新技术，巩固药明生物全球技术领导者的地位
中国，无锡
2021年11月1日
全球领先的开放式生物制药技术平台公司药明生物（WuXi Biologics, 2269.HK）宣布公司无锡生物制剂二厂（DP2）已正式投入GMP生产。作为药明生物投产的第八个生物制剂厂，DP2将大幅提升公司在商业化生物制剂方面的服务能力，进一步巩固全球生产版图，为合作伙伴加速赋能。
DP2占地面积约1.2万平方米，配备先进的隔离器灌装生产线，能够为全规格（2\6\8\10\20\50R）水针注射剂产品和20m2/40m2冻干注射剂产品提供连续高速灌装服务。DP2的优化设计可实现不同规格产品的快速切换，最大程度提升灌装生产效能，满足客户对于不同工艺、规模和阶段生物制剂的服务需求。以一般生物制剂的商业化生产为例，DP2产能将高达6000万瓶。该厂还采用了一次性蠕动泵灌装系统和一次性PUPSIT除菌过滤系统，不仅能够满足现行法规要求，并且前瞻性地考虑了全球法规演进趋势。这些一次性生产系统的应用也再次彰显了药明生物作为一次性生产技术领导者的地位。
凭借卓越的厂房布局和工艺设备，DP2能够极大地消除交叉污染风险，保障制剂产品的无菌性，并且能够为单克隆抗体、双特异性抗体、融合蛋白等多种创新产品加速提供多样化的制剂生产服务，有力地支持公司在四周内启动任意项目。DP2灌装生产线还配备一次性和不锈钢两种配液系统，具有降低能耗和绿色环保等优势。
此外，药明生物全新的制剂包装中心（DPPC）也同步投入GMP生产。该中心配备首条全自动商业化西林瓶包装线，按照美国、欧盟和中国cGMP标准建立，并应用防伪药品追踪、自动化智能贴标和包装等先进技术，为客户提供定制化的端到端生产服务，尤其是加快大批量临床和商业化项目产品的终端包装服务，加速产品的商业化生产进程。
药明生物首席执行官陈智胜博士表示，“我们非常高兴正式投产药明生物最大规模的商业化生物制剂厂DP2以及首条全自动商业化西林瓶包装线，进一步为全球合作伙伴提供高产能、高效率、高质量的一体化生物制剂服务，为其临床试验、产品注册及商业化生产提供有力支持。”
他进一步补充道，“我们的业务根植于日益增长的客户需求和蓬勃发展的生物制药市场。随着全球合作伙伴不断将前沿理念转化为创新疗法，生物药研发和生产服务需求随之提升，我们持续在全球范围内扩大技术和能力规模，也正是为了更好地满足客户的需求。作为全球医药健康产业的赋能者和贡献者，我们致力于帮助合作伙伴研发和生产更多用得到、用得起的高质量生物药，造福广大病患。”
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WuXi Biologics Launches a New GMP Commercial Drug Product Facility
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Enhances drug product services for projects at various stages, with an emphasis on late and commercial stage production
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Increases up to 60 million vials for commercial drug production per year
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Consolidates WuXi Biologics’ pioneering the application of innovative technologies such as single-use and automation
WUXI, China
November 1, 2021
WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced it has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global network of WuXi Biologics.
The 12,000m² drug product facility, called DP2, features a state-of-the-art isolator filling line for the continuous high-speed production of wide size range – from 2R to 50R of liquid and 20m2/40m2 of lyophilization. Leveraging its innovative design, the facility can switch rapidly between different specifications to maximize its filling efficiency, providing flexible drug product manufacturing solutions to meet customers' needs. DP2 will increase up to 60 million vials for commercial drug production of biologics per year. This facility serves as an example of WuXi Biologics' implementation of single-use technology as it utilizes disposable peristaltic pump filling systems and sterile filtration systems in pre-use post sterilization integrity testing (PUPSIT), which meet current and evolving global regulatory requirements.
With its advanced layout and equipment, the facility effectively eliminates cross-contamination and ensures product sterility while accelerating drug product services across multiple modalities – such as monoclonal antibodies, bispecifics and fusion proteins – and enables the company to initiate any client project within four weeks. The application of both single-use and stainless-steel formulation systems helps reduce energy consumption, resulting in greater productivity and lowered environmental impact.
In addition, WuXi Biologics has also launched the GMP operation of a new Drug Product Packaging Center (DPPC) which includes the company's first fully automated vial packaging line. This packaging line is designed to meet U.S. FDA, EMA and China's NMPA GMP requirements and will leverage new technologies – including anti-forgery drug tracking as well as automatic intelligent labeling and packaging – to not only provide customized end-to-end manufacturing services for clients, but also accelerate the process of high-volume clinical and commercial projects.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We're excited about the successful GMP launch of the first fully automated vial packaging line as well as DP2, the largest commercial drug product facility at WuXi Biologics. These will allow us to further provide high-yield, high-efficiency, and high-quality drug product services to support our global clients' clinical trials, product registration, and commercial authorization."
Dr. Chen said, "Our business strategy in both building and acquiring new facilities has been driven by global customer demand and the robust biologics market. Expanding our capacity and capabilities around the world embodies our commitment to our customers as they pursue innovative ideas and achieve advances that benefit patients worldwide. As a contributor to the global healthcare industry, WuXi Biologics is committed to making more high-quality biologics available and affordable for patients in need."
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
