全球播报:合全药业全新高活原料药生产车间正式投入使用

快 讯

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▲常州基地全新高活原料药生产车间-3000 L反应釜

近日，在药明康德子公司合全药业位于常州的原料药研发及生产一体化基地，又一个高活原料药生产车间正式投入使用，更好地满足全球合作伙伴对高活原料药研发和生产服务日益增长的需求。

该高活原料药生产车间恪守全球最高质量标准，采用自带密闭隔离系统的三合一，配置了从 250 L到3,000 L不同规模的多个反应釜，各种规模的高活液相制备色谱以及高达10m2的高活平板冻干机，可生产职业暴露限值（Occupational Exposure Limit, OEL）要求低至10 ng/m3的高活化合物。这是合全药业在常州基地投产的第2个高活原料药生产车间，旨在进一步扩大高活原料药的大规模生产能力，能为合作伙伴将高活项目推向商业化生产提供强有力的支持。

合全药业高活原料药平台分别在常州基地和上海金山基地拥有多间高活研发实验室、分析实验室、公斤级实验室及3个商业化生产车间，为全球客户搭建起基于两个基地的双重、稳健的供应链。此外，高活原料药平台还拥有流动化学、磨粉等领先技术，满足从临床前到商业化不同阶段的各类项目需求。除了高活原料药，合全药业常州基地还具备连接子（Linker）、寡核苷酸和多肽的工艺开发和生产能力，能为合作伙伴开发各类复杂偶联药物提供高效灵活的“一站式”解决方案。

作为CRDMO领军企业，未来，合全药业还将持续提升高活原料药的研发和生产能力，帮助合作伙伴突破技术和产能瓶颈，让更多创新疗法早日上市，造福全球病患。

WuXi STA Opens Another High-Potency API Plant in Changzhou, China

NEWS

▲3000 L reactor in the new HPAPI plant at WuXi STA’s Changzhou site

Shanghai, China – June 25, 2022 – WuXi STA, a WuXi AppTec company, has opened another high-potency API (HPAPI) plant at its Changzhou site (Jiangsu, China). The new plant is added to meet the growing demand for high-potency API process R&D and manufacturing services.

The new HP plant consists of reactors from 250 L to 3,000 L, prep-HPLC systems, a 10 m2tray lyophilizer, as well as flow chemistry and milling technologies. The new plant adopts advanced isolation technologies with the capability to handle potent compounds with Occupational Exposure Limit (OEL) as low as 10 ng/m3.

Currently, WuXi STA has two sites located in Shanghai Jinshan and Changzhou, China to support the process development and manufacture of high-potency active pharmaceutical ingredients. These two facilities are equipped with multiple HP process R&D and analytical labs, kilo labs, and three plants along with various process technologies such as prep-HPLC, milling, flow chemistry etc., providing customers a dual supply chain to meet their HPAPI needs from preclinical to commercial. In addition to HP API, WuXi STA’s Changzhou site is capable of handling the process development and manufacturing services for linkers, oligonucleotides, and peptides, providing a unique “one-stop” flexible and efficient solution to companies developing therapies made of various complex conjugate modalities.

As an industry-leading CRDMO service provider, WuXi STA is committed to continuously adding new capabilities and capacities to our global network to support our global partners by accelerating more innovative therapies to patients worldwide.