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默克宣布首条符合GMP的细胞培养基(CCM)生产线在中国开始商业化生产

Merck Begins Commercial Production of First GMP-Compliant Manufacturing Line for Cell Culture Media in China

默克 等信源发布 2024-07-16 00:57

可切换为仅中文


€ 6.6 million investment at Nantong site expands production capabilities for cell culture media

南通工厂投资660万欧元,扩大了细胞培养基的生产能力

Supports local biopharma manufacturers to meet growing demand for novel medicines

支持当地生物制药制造商满足不断增长的新药需求

Enables smooth transition from pilot to commercial-scale, speeding time to market and access to life-saving therapies

实现从试点到商业规模的平稳过渡,加快上市时间和获得挽救生命的疗法

Merck, a leading science and technology company, today announced the start of commercial production of its first GMP (Good Manufacturing Practices) compliant manufacturing line for cell culture media (CCM) in China. The approximate € 6.6 million investment at its Life Science Center in Nantong – a major industrial hub in the Yangtze River Delta region – aims to address the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.

领先的科技公司默克(Merck)今天宣布,其在中国的第一条符合GMP(良好生产规范)的细胞培养基(CCM)生产线开始商业化生产。位于长三角地区主要工业中心南通的生命科学中心投资约660万欧元,旨在满足当地对用于生物制药、疫苗和新型疗法的优质定制CCM日益增长的需求。

Commercialization of the local production line enables Chinese customers to access Merck’s well-established custom CCM products and services in a reliable and efficient manner. Leveraging extensive in-house formulation knowledge, Merck designs robust custom CCM for customers’ specific processes and creates innovative solutions that enhance consistency and efficiency of their processes..

当地生产线的商业化使中国客户能够以可靠和高效的方式获得默克公司成熟的定制CCM产品和服务。默克利用广泛的内部配方知识,为客户的特定流程设计强大的定制CCM,并创建创新解决方案,以提高流程的一致性和效率。。

“This investment further expands Merck's footprint and capabilities in China, showcasing our commitment to the development of the local biopharma industry,” said Roy Wu, Managing Director of the Life Science business sector, Merck China. “The new cell culture media manufacturing line is a positive proof of our commitment to improve patient care by leveraging our innovative spirit and global network of expertise.”.

“这项投资进一步扩大了默克在中国的足迹和能力,表明了我们对当地生物制药行业发展的承诺,”默克中国生命科学业务部门董事总经理Roy Wu表示。“新的细胞培养基生产线积极证明了我们通过利用我们的创新精神和全球专业网络来改善患者护理的承诺。”。

Applying media components from qualified sources only, the Nantong GMP facility allows for a smooth transition from pilot to commercial-scale cell culture production with comprehensive regulatory documentation. Along with tailor-made dry powder CCM products, customized technical and operational assistance will also be provided to support local biopharma manufacturers’ processes and shorten time to market.

南通GMP设施仅使用合格来源的培养基成分,可以通过全面的监管文件从中试到商业规模的细胞培养生产顺利过渡。除了定制的干粉CCM产品外,还将提供定制的技术和运营援助,以支持当地生物制药制造商的流程并缩短上市时间。

Product lead time is expected to be reduced as a result of local manufacturing..

由于本地制造,预计产品交付周期将缩短。。

“The Nantong Economic and Technological Development Area (NETDA) is focused on accelerating high-quality development of its biopharma industry,” said Cao Haifeng, Deputy Secretary of NETDA Party Working Committee and Director of NETDA Administrative Committee. “The project of Merck's Life Science Center in Nantong will provide important contributions to the biopharma eco-system of the region.”.

南通经济技术开发区党工委副书记、管理委员会主任曹海峰表示:“南通经济技术开发区(NETDA)致力于加快生物制药产业的高质量发展。”。“南通默克生命科学中心项目将为该地区的生物制药生态系统做出重要贡献。”。

Merck provides a full range of innovative solutions to local and global biopharma customers. In addition to CCM, the Life Science business offers an extensive range of products, including cell lines, bioreactors, filters, resins, chromatographic, pharmaceutical raw materials, and excipients. Its end-to-end process solutions are designed to comprehensively support biopharma manufacturers from process development to scale-up, benefiting patients and contributing to the advancement of global health. .

默克为本地和全球生物制药客户提供全方位的创新解决方案。除CCM外,生命科学业务还提供广泛的产品,包括细胞系、生物反应器、过滤器、树脂、色谱、药物原料和赋形剂。其端到端流程解决方案旨在全面支持生物制药制造商从流程开发到规模扩大,使患者受益并为全球健康的进步做出贡献。。