合全药业在无锡基地投产全新无菌注射剂生产线

位于合全药业无锡基地的全新无菌注射剂生产线

中国上海，2022年11月30日--药明康德子公司合全药业宣布，其位于无锡制剂基地的又一全新全自动隔离无菌注射剂生产线正式投产。这是合全药业今年投产的第2条全自动隔离无菌注射剂生产线，年产能达1000万支注射剂，意味着公司在持续提升无菌注射剂平台能力。

该无菌注射剂生产线以业界领先的全隔离器灌装技术为核心，配备适用于全隔离器的15㎡冻干机及自动进出料系统，可生产多种规格的西林瓶水针以及冻干注射剂产品，并能实现不同规格产品的快速切换，灌装速度能稳定达到200支/分钟，可显著加快大规模注射剂产品的生产速度。该生产线及其所在的制剂车间均按照全球cGMP要求进行设计建造，配备行业领先的全封闭隔离系统以及灌装机，从清洗、烘干到灌装、冻干进出料等全流程均实现自动化，最大程度上减少人为干预，全方位避免污染，为无菌产品提供了坚实的质量保障。

合全药业无锡基地是制剂研发和生产一体化基地，具备全面的分析能力，能针对各种不同剂型的口服制剂和注射制剂，提供端到端服务。该基地目前已通过欧洲药品管理局（EMA）、中国国家药品监督管理局（NMPA）的药品上市前检查，与公司其他基地施行统一的质量体系。位于该基地的注射剂平台可支持多种分子形式，包括小分子、寡核苷酸、多肽和复杂偶联药物。协同无菌脂质纳米粒 (Lipid Nanoparticles, LNP) 制剂平台，无锡基地可以更好地为寡核苷酸及其偶联药物提供制剂研发和生产服务。

公司将持续提升注射剂平台能力，2023年合全药业还将在无锡基地启用首条高活无菌注射剂生产线。此外，公司位于美国特拉华州米德尔敦的制剂基地预计2025年正式投入运营，位于该基地的注射剂平台将面向全球合作伙伴，提供注射剂研发和生产一体化服务，进一步增强注射剂平台能力。

药明康德联席首席执行官、合全药业首席执行官陈民章博士表示：“很高兴我们的注射剂平台能力持续升级以更好地满足客户需求。合全药业致力于打造行业最高、最宽和最深的能力和技术平台，我们将继续增强一体化CMC平台能力，探索行业前沿技术，赋能全球合作伙伴加速创新药开发进程，造福病患。”

合全药业是药明康德子公司，在亚洲、北美及欧洲地区均设有研发及生产基地。合全药业服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合同研究、开发与生产领域（CRDMO）的领军企业，合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案，以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息，请访问公司网站：www.stapharma.com.cn

Shanghai, China, November 30, 2022–WuXi STA, a subsidiary of WuXiAppTec, announced a new parenteral formulation manufacturing line has started operation at the drug product site in Wuxi city, China. It is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units. This expansion demonstrates the company’s continuous commitment to enhance its injectable drug product platform.

This new line features a fully automatic vial loading/unloading system and a built-in 15 ㎡ lyophilizer in a fully enclosed isolator. The filling line supports vials in a full range of sizes for solutions and lyophilized powder while allowing rapid switches between modes for maximum filling flexibility and efficiency. The filling speed can reach 200 vials per minute, significantly accelerating large-volume parental drug product production speed.  This facility is designed per global cGMP standards, equipped with state-of-the-art containment system and advanced filling machine. From vial cleaning, drying, filling to freeze-drying, the entire process is wholly automated in the isolator to ensure high product quality with minimal human interventions.

Located in Jiangsu, China, the Wuxi city site is an integrated drug product R&D and manufacturing campus with the comprehensive analytical platform for both oral and injectable formulations.  The site has passed Pre-Approval Inspections from both European Medicines Agency (EMA) and China National Medical Products Administration (NMPA), sharing the same proven quality system across all sites within WuXi STA.  The injectable platform at the site supports all synthetic modalities including small molecules, oligonucleotides, peptides and complex conjugates.  With the advanced sterile lipid nanoparticle (LNP) facility at Wuxi city, the site is well positioned to provide formulation development and manufacturing for oligonucleotides and the conjugates.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am glad that our parenteral drug product capacity has been expanded to meet the growing demands. WuXi STA is committed to strengthening our integrated CMC platform and building first-in-class facilities with cutting-edge technologies. We strive to provide our global partners with flexible, fast, and cost-efficient solutions to accelerate new therapies to market for patients worldwide."

WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. 

For more information, please visit: http://www.STApharma.com