药明生物爱尔兰基地再迎多项里程碑：多个16000L规模PPQ生产批次成功并获HPRA GMP认证|药明生物_新浪财经

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成功完成多个16000升规模PPQ生产，再次证明一次性生物反应器媲美传统不锈钢生物反应器的生产效益

获得HPRA GMP认证，彰显公司新运营的全球基地已建立世界一流的质量体系

爱尔兰敦多克

2024年12月6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）今日宣布其位于爱尔兰的先进绿色生产基地的多项重要业务进展。公司生物药原液生产七厂（MFG7）完成多批16000升规模工艺性能确认（PPQ）生产。该基地目前已经以100%成功率完成两个项目的PPQ生产，并同时获得爱尔兰健康产品监督管理局（HPRA）对所有三个生物药原液生产厂的GMP认证。这些里程碑也凸显了爱尔兰基地在药明生物全球生产网络中提供世界一流的生物制药解决方案的关键作用。

通过组合4个4000升一次性生物反应器，药明生物爱尔兰基地PPQ生产达到单批次16000升的生产规模，这也是全球使用一次性生物反应器的最大规模补料分批细胞培养工艺之一。该里程碑不仅为整个生物制药行业树立了新标杆，贯彻了ESG理念，还证明了公司能够实现与大规模不锈钢生物反应器相媲美的成本控制能力。

在今年10月，药明生物爱尔兰多产品生产基地顺利通过HPRA的全面现场检查，检查范围覆盖数据管理、工艺控制、人员管理、生产、存储及分析等全流程的GMP合规性要求，并获得了GMP认证。此次GMP认证再次印证了其遵守法规监管标准的承诺，未来药明生物爱尔兰基地将进一步为全球客户提供临床和商业化生物药原液生产服务，惠及广大病患。截至目前，药明生物已成功通过全球主要药品监管机构近40次检查，并获得了67项许可证书。

陈智胜

博士

药明生物首席执行官

这些里程碑不仅体现了我们爱尔兰团队卓越的速度、敏捷性和执行力，更进一步彰显了公司对于高质量标准、创新实践以及可持续发展的不懈承诺与坚定决心。爱尔兰基地的成功也进一步夯实了我们全球生产网络，助力公司赋能全球客户开发和生产更多高质量、拯救生命的疗法，造福全球病患。

自2022年3月投入运营以来，药明生物爱尔兰基地已迅速成为全球生物制药领域的佼佼者。该基地拥有超过760名专业人才，集前沿设计建造、可持续发展理念、可拓展性等优势于一身，拥有三个业界领先的生物药原液生产厂，分别配备48000升流加细胞培养生物反应器（MFG7）和6000升灌流工艺生物反应器（MFG6.1和MFG6.2）。

该GMP认证基地以世界一流的质量和效率提供临床和商业化生产服务，并已获得ISO 50001（能源管理体系）、ISO 14001（环境管理体系）和ISO 45001（职业健康与安全管理体系）认证，彰显了公司对可持续发展的坚定承诺。药明生物爱尔兰基地还获得了国际制药工程协会（ISPE）颁发的2023年度最佳设施奖。

关于药明生物

药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。

药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12000名员工。通过药明生物的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2024年6月底，药明生物帮助客户研发和生产的综合项目高达742个，其中包括16个商业化生产项目（不包括新冠项目和非活跃项目）。

药明生物将环境、社会和治理（ESG）视为业务发展和企业精神的重要组成部分，并致力于成为全球生物药CRDMO领域的ESG领导者，例如应用更绿色环保的新一代生物制药技术和能源等引领行业发展。公司成立了由首席执行官领导的ESG委员会，全面落实ESG战略并践行可持续性发展承诺。更多信息，请访问：www.wuxibiologics.com。

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WuXi Biologics Achieves Major Milestones at Ireland Site with Multiple 16,000L PPQ Success and HPRA GMP Authorizations

Multiple successful 16,000L PPQ runs highlight that disposable manufacturing can achieve similar performance as traditional stainless reactors

GMP Authorizations by HPRA demonstrate that new global sites have built strong world-class regulatory and quality system

Dundalk, Ireland,

December 6, 2024

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced major accomplishments at its cutting-edge greenfield site in Dundalk, Ireland. The site has successfully completed multiple 16,000-liter Process Performance Qualification (PPQ) runs at its MFG7 drug substance suite. So far, the site has completed two PPQ runs with 100% success rate. In addition, all three manufacturing facilities received GMP approval from the Irish Health Products Regulatory Authority (HPRA) at the same time. These milestones underscore the site's critical role in delivering world-class biomanufacturing solutions across WuXi Biologics global network.

These PPQ runs achieved 16,000-liter scale by combining four 4,000-liter single-use bioreactors, representing one of the largest cell culture processes using single-use technology worldwide. The scale-up was not only innovative and more ESG-friendly, but also demonstrated the company's ability to deliver comparable Cost of Goods (COGS) to traditional large-scale stainless-steel bioreactors up to 20,000L.

The GMP authorization was granted by HPRA following a comprehensive on-site inspection in October 2024, which evaluated the GMP oversight of all data, processes, personnel, manufacturing, storage, and analytical areas across the multi-product facility. The granting of this approval provides WuXi Biologics the opportunity to expand its services to support the unmet needs of patients worldwide and highlights the commitment to comply with standards and legislation allowing it to release clinical and commercial biologics drug substances for global clients, benefiting patients worldwide. To date, the company has passed approximately 40 global regulatory inspections and has received 67 license approvals.

Dr. Chris Chen

Chief Executive Officer

WuXi Biologics

These accomplishments reflect the remarkable speed, agility, and execution capabilities of our Ireland site while underscoring WuXi Biologics' unwavering commitment to quality, innovation, and sustainability. The successful completion of these milestones strengthens our global manufacturing network and supports our mission to deliver high-quality, life-saving treatments for patients around the world.

Since becoming operational in March 2022, WuXi Biologics Ireland site that began as greenfield development in Dundalk has rapidly established itself as a leader in advanced biomanufacturing. With over 760 skilled employees, the facility combines cutting-edge design, sustainability, and scalability. Recognized with the prestigious International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Award (FOYA) in 2023, the site features three advanced drug substance manufacturing suites: 6,000L perfusion suite (MFG6.1 and MFG6.2) and a 48,000L fed-batch suite (MFG7).

In addition to its manufacturing capabilities, the site is deeply committed to sustainability, holding ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001). These achievements demonstrate WuXi Biologics' dedication to advancing the industry through innovation and environmental responsibility.

About

WuXi Biologics

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.

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 June 30, 2024, WuXi Biologics is supporting 742 integrated client projects, including 16 in commercial manufacturing (excluding COVID CMO and non-COVID dormant CMO projects).

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities a an integral component of our ethos and business strategy, and we aim to become 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.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com