合全药业无锡制剂研发中心投入运营，制剂服务水平实现新跃升

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关键词：制剂投入运营药药业研发中心

资讯来源：药明康德

发布时间： 2021-05-21

wuxi city

无锡，2021年5月20日——药明康德子公司合全药业今日宣布，位于江苏省无锡市新吴区的制剂研发中心正式投入运营。随着研发中心的启用，合全药业无锡基地将成为继上海外高桥基地之后，又一个创新药制剂项目的一体化基地，为全球合作伙伴提供从临床前研发到商业化生产的端到端服务，更好地服务全球病患，同时也进一步巩固了其在CDMO行业的领军地位。

新落成的制剂研发中心位于合全药业无锡基地内，建筑面积11,000平方米，将入驻500多名科学家，包括口服制剂平台、无菌注射剂平台以及分析测试平台。其中，口服制剂研发平台配备了湿法和干法制粒系统、胶囊和片剂配方研发设备、包衣及中控研发设备等，支持从临床前到商业化生产的工艺研发；无菌注射剂平台能够提供西林瓶、预充针和卡氏瓶等多种灌装形式，以及冻干工艺研发，灵活满足客户多样化的需求。

目前合全药业无锡基地拥有两个商业化固体制剂车间，为全球客户提供新药制剂生产、包装和贴标服务。而在今年第三、四季度，新的口服制剂GMP生产车间及首条无菌注射剂GMP生产线将陆续投产。一系列新技术平台，包括口服制剂连续化生产线等，也将在2022年陆续投入使用。无锡基地将充分发挥制剂业务一体化的独特优势，为客户提供研发与生产紧密结合的高效服务。

在此次落成典礼上，合全药业同时发布了两个独特的制剂一体化解决方案：F2CS – Fast to Clinical Supply 以及F4CM - Fast for China Market。凭借合全制剂开发经验丰富的团队、业界领先的技术、设备和产能，为早期客户快速开始临床实验和为后期项目尽快在中国上市而量身打造了这两款新的定制服务，助力加快合作伙伴新药上市的脚步。

作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业在制剂业务领域布局已久，服务涵盖制剂研发、生产以及分析服务的全产业链，从药物固态研究、处方前开发、处方开发、到临床及商业化GMP的制剂产品供应等“一站式”服务，能够提供各种不同剂型的口服制剂和注射制剂。此外，合全还搭建了业界前沿的增溶技术平台，包括喷雾干燥、热熔挤出、纳米悬浮液、软胶囊及液体填充硬胶囊，并于去年利用喷雾干燥技术支持创新药奥布替尼在中国成功上市，再一次成为了CDMO行业的先行者。

2020年，合全药业制剂平台能力达到了一个新高度，生产超过1200制剂批次，支持全球临床实验。此次无锡制剂研发中心的落成，将进一步提升公司制剂业务的赋能水平，并与原料药业务平台形成更强大的合力，充分发挥上下游协同效应，加速新药开发进程。

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合全药业首席执行官陈民章博士表示：

很高兴我们的无锡制剂研发中心正式投入运营，这将助力公司进一步拓宽制剂业务赋能平台。合全药业潜心深耕CDMO领域近20年，赋能客户、造福病患的初心始终如一，未来，我们将持续拓展包括从原料药到制剂的‘端到端’平台的能力与规模，借助符合国际标准的质量体系，赋能更多合作伙伴将更多新药、好药加速上市，尽早惠及全球病患。

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关于合全药业

合全药业是药明康德子公司，在全球多地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。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供从临床前到商业化，高效、灵活、高质量的一站式CMC（化学、生产和控制）解决方案。更多信息，请访问公司网站：www.STApharma.com.cn

WuXi STA Opens New Drug Product

Facility in Wuxi City Site

wuxi city

Wuxi city, China, May 20, 2021- STA Pharmaceutical, a WuXi AppTec company, today announces the opening of a new R&D center in Wuxi city site. With the new facility in operation, the Wuxi city site now becomes the second integrated drug product R&D and manufacturing campus for WuXi STA, in addition to its Shanghai Waigaoqiao site.

The new R&D center in Wuxi city site, with the area of 118,400 square feet to house more than 500 scientists, includes oral dosage platform, sterile injectable platform as well as analytical testing platform. The oral dosage platform is equipped with wet granulation and roller compaction systems, capsule and tablet formulation equipment, coating and in process control R&D equipment, etc., to provide R&D support to projects from preclinical to commercial. The sterile injectable platform provides a variety of filling formats such as vial, prefilled syringe and cartridge. It can also handle freeze-drying process.

Currently, the Wuxi city site has two oral solid commercial-scale plants, to provide manufacturing, packaging and labeling services. In the third and fourth quarters of this year, a new oral solid dosage GMP manufacturing plant and the first sterile injectable GMP manufacturing line will start operation. Furthermore, various novel technology platforms, such as continuous manufacturing lines for oral solid formulation will be available by early 2022.

At the opening ceremony, WuXi STA also launched two unique drug product service packages: F2CS: Fast to Clinical Supply and F4CM: Fast for China Market. F2CS is designed to shorten the time it takes to develop formulation and deliver clinical trial material for Phase I studies, and F4CM is designed to shorten the time it takes to complete technical transfer, late phase development, and process validation in China market.

As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA is fully established in the drug product field, offering fully integrated drug product solutions, including solid state development, developability and formulation research, formulation development, and Clinical Trial Material (CTM) and commercial manufacturing in various oral and injectable dosage forms. WuXi STA also built a comprehensive bioavailability enhancement technology platform including spray dried dispersion (SDD), hot melt extrusion, nano suspension and softgel & liquid filled hard capsules.

In 2020 alone, WuXi STA's successfully delivered over 1200 drug product batches to partners around the world. In addition, WuXi STA successfully supported the launch of InnoCare's Orelabrutinib in China market, providing end-to-end support including drug substance, amorphous solid dispersion, tablet and packaging for this product.

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Dr. Minzhang Chen, CEO of WuXi STA, commented:

we are glad to launch the Wuxi city formulation R&D center to further enhance our drug product platform. We will continue to expand our end-to-end CMC platform from drug substance to drug product, along with the global quality systems, to enable our partners worldwide to deliver more effective and accessible advanced therapies to patients globally.

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About WuXi STA

WuXi STA, a subsidiary of WuXi AppTec, 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 (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com and follow us on LinkedIn.