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药明生基全新生产基地投入运营,进一步为全球客户提供CTDMO


发布时间:2021-10-18 药融圈
注:本文不构成任何投资意见和建议,以官方/公司公告为准;本文仅作医疗健康相关药物介绍,非治疗方案推荐(若涉及)。因水平有限,错误不可避免,或有些信息非最及时,欢迎留言指出。

 

 

药明生基全新生产基地投入运营,进一步为全球客户提供CTDMO一体化服务


中国上海,2021年10月18日 -- 药明康德旗下专注于细胞和基因疗法的CTDMO药明生基今日宣布,公司在上海临港新建的工艺研发和商业化生产中心正式投入运营。作为药明生基全球第四个生产基地,该中心将有力补充公司的全球化运营网络,并与美国、英国和中国的其他三个基地联动,通过强大的产能布局为全球客户提供更高效的服务。

投入运营后,临港基地将为病毒载体和细胞疗法提供一体化的工艺开发、生产和测试服务。新基地配备200多个独立套间和6条完整的载体和细胞生产线,包含独立的配液中心和GMP级别无菌灌装隔离器。这些设施将进一步增强药明生基的全球化产能,从而在病毒载体和细胞疗法服务方面为客户提供更大的灵活性和更快的交付时间。


去年,药明生基完成了美国费城细胞及基因疗法生产基地的扩建,将高端检测产能提升了三倍。此次新建临港基地是药明生基全球化平台建设的又一重要举措,通过不断建能力、扩规模,持续为全球客户提供高质量的解决方案。


 “细胞及基因疗法在帮助预防、治疗许多重症及罕见病方面起到了至关重要的作用,这也是药明生基不断拓展细胞及基因疗法服务平台的初衷。”药明生基首席执行官张幼翔博士表示:“通过扩大全球运营网络,我们将进一步提升药明生基CTDMO服务平台的能力和规模,赋能全球客户为患者带来更高效、可及的先进疗法。”


作为一个全球化运营的CTDMO,药明生基独特的商业模式将强大的测试能力与工艺开发及生产平台能力紧密结合,如用于腺相关病毒(AAV)生产的新型TESSA技术和用于慢病毒稳定生产的XLenti解决方案等。通过药明生基的一体化赋能平台,所有的检测开发、生物安全、病毒清除和最终产品放行检测等环节都能在这个平台上得以实现,帮助客户大幅缩短先进疗法的上市周期。

关于药明生基

药明生基是药明康德旗下专注于细胞和基因疗法的CTDMO,致力于加速和变革细胞治疗、基因治疗及其他高端治疗的开发、测试、制造和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场,造福病患。更多信息,请访问www.advancedtherapies.com。

关于药明康德

药明康德(股票代码:603259.SH/2359.HK)为全球生物医药行业提供一体化、端到端的新药研发和生产服务,在亚洲、欧洲、北美等地均设有运营基地。药明康德通过独创的“CRDMO”和“CTDMO”业务模式,不断降低研发门槛,助力客户提升研发效率,为患者带来更多突破性的治疗方案,服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。2021年,药明康德被MSCI评为ESG(环境、社会及管治)AA级。目前,公司的赋能平台正承载着来自全球30多个国家的5200多家合作伙伴的研发创新项目,致力于将更多新药、好药带给全球病患,早日实现“让天下没有难做的药,难治的病”的愿景。更多信息,请访问公司网站:www.wuxiapptec.com


WuXi ATU Opens New Manufacturing Facility to Further Enhance Its CTDMO Services for Global Customers 

Philadelphia, 17 October 2021 - WuXi Advanced Therapies Inc. (WuXi ATU) – a wholly owned subsidiary of WuXi AppTec – today announced the opening of its new process development and commercial manufacturing facility in Lin-gang, Shanghai. WuXi ATU is a leading Contract, Testing, Development and Manufacturing Organization (CTDMO) headquartered in Philadelphia. As its fourth manufacturing site worldwide, the new facility will supplement WuXi ATU’s global footprint and will further join with other sites in the United States, United Kingdom and China to enable global customers with enhanced capacity and efficient services.


 

The Lin-gang facility offers integrated development, manufacturing, and testing services for viral vectors and cell therapies. It contains more than 200 independent suites and six complete production lines, including an independent liquid distribution center and independent GMP standard sterile filling isolator. These resources will strengthen WuXi ATU’s operations worldwide, offering customers greater flexibility and speed in the delivery of viral vectors and cell therapies.


The Lin-gang facility’s opening follows a major expansion of WuXi ATU’s Philadelphia Navy Yard campus in 2020 that tripled its advanced testing capacity and provided much needed services for clients globally.


“Cell and gene therapies play a critical role in helping treat and prevent many severe and rare diseases, which is why WuXi ATU is committed to growing our comprehensive one-stop service platform specifically dedicated to the gene and cell therapy field,” said Dr. David Chang, Chief Executive Officer of WuXi ATU. “By expanding our global footprint, we will provide enhanced cell and gene therapy manufacturing services for our customers worldwide and better enable them to deliver more effective and accessible advanced therapies to patients.” 

 


As a CTDMO with operations globally, WuXi ATU’s unique business model integrates powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, so that all assay development, biosafety, viral clearance and product release testing can be carried out in house, enabling customers to shorten the timeline for the approval of advanced therapies.
 

About WuXi Advanced Therapies
(WuXi ATU)
 

As the wholly owned subsidiary of WuXi AppTec, WuXi ATU is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.

For more information, please visit www.advancedtherapies.com.
 

About WuXi AppTec
 

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,200 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com

 

 

 

 

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