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WuXiUITM超强化分批补料生物工艺平台实现了优异的工艺表现,大幅提高产量和质量,降低商业化生产成本,为客户生物药的研发与生产提供更多元的工艺选择
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该平台设计独特,具有出色的适配性,适用于主流细胞系和多种分子类型
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WuXiUITM彰显了药明生物将可持续的创新发展理念融入CRDMO业务
无锡,
2023年10月17日
全球领先的合同研究、开发和生产(CRDMO)服务公司药明生物(WuXi Biologics, 2269.HK)宣布推出全新生物工艺技术专利平台WuXiUITM。该平台是基于超强化的流加细胞培养工艺开发的解决方案,能够提升不同CHO细胞系及其他哺乳动物细胞系所表达的多种产品类型的产量和质量。
当前生物工艺开发不仅聚焦提高产量、降低生产成本(COGS),并且更关注在生物制药生产过程贯彻环境、社会和治理(ESG)理念。为了满足这些需求,药明生物开发了WuXiUITM平台,为全球客户提供灵活且具有成本效益的新型生物工艺解决方案。与常规流加细胞培养工艺相比,WuXiUITM通过创新性地结合超强化流加培养与间隙型灌流工艺,可以将单克隆抗体、双特异性抗体和重组蛋白等不同分子类型的产量在同等培养时间内提高3到6倍,同时保证产品质量。例如,一款双抗生产工艺借助WuXiUITM在14天内实现了高达25克/升的产量,在保证质量满足客户要求的基础上,产量相比同等规模的传统流加细胞培养工艺提高了5倍。
据估算,与传统流加细胞培养工艺相比,WuXiUITM可将一次性生物反应器中的原液生产成本降低60~80%,极大地增强了商业化产品的市场竞争力。该技术平台也易于在现有生产设施中应用和放大生产,无需额外的主要设备或复杂操作,并可沿用常规下游生产工艺进行蛋白纯化。WuXiUITM还秉承药明生物ESG策略,相较于传统或者其他强化流加细胞培养工艺,显著降低培养基消耗和废液体积,为环境保护做出积极贡献。
陈智胜
博士
药明生物首席执行官
我们很高兴推出 WuXiUITM技术平台,提供多元化的生物工艺解决方案,帮助全球客户提高产量和质量,降低生产成本。长期以来,药明生物不断推陈出新,持续打造新型技术平台,突破业界技术瓶颈,促进生物技术创新,这一切都是为了更好地赋能全球合作伙伴,让全球患者用得到、用得起更多高质量生物药。
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关于药明生物
药明生物(股票代码:2269.HK)是一家全球领先的合同研究、开发和生产(CRDMO)服务公司。公司通过开放式、一体化生物制药能力和技术赋能平台,提供全方位的端到端服务,帮助合作伙伴发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。
药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12000名员工。通过药明生物人的专业服务团队,以及先进技术和精深洞见,公司为客户提供高效经济的生物药解决方案。截至2023年6月底,药明生物帮助客户研发和生产的综合项目高达621个,其中包括22个商业化生产项目。
药明生物将环境、社会和治理(ESG)视为业务发展和企业精神的重要组成部分,并致力于成为全球生物药CRDMO领域的ESG领导者,例如应用更绿色环保的新一代生物制药技术和能源等引领行业发展。公司成立了由首席执行官领导的ESG委员会,全面落实ESG战略并践行可持续性发展承诺。
更多信息,请访问:www.wuxibiologics.com
媒体关系 PR@wuxibiologics.com
业务垂询 info@wuxibiologics.com
WuXi Biologics Launches New High-Productivity Bioprocessing Platform WuXiUI™ for Cost-Effective Commercial Manufacturing and Desirable Product Quality
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WuXiUITM ultra-intensified fed-batch platform offers a new process option for maximum flexibility to meet various clients' needs in biologics development and manufacture. The platform can significantly improve productivity and quality, and reduce cost-of-goods (COGS) in commercial manufacturing
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The platform's unique design allows for outstanding adaptability for all common cell lines and diverse modalities
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WuXiUITM showcases WuXi Biologics' efforts to incorporate sustainable and innovative concepts in its CRDMO services
Wuxi,
October 17, 2023
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has launched a new proprietary bioprocessing platform WuXiUITM, an ultra-intensified, fed-batch solution that enhances the productivity and quality of multiple different CHO or other mammalian cell lines and product modalities.

To meet increasing demands for yield improvement, COGS reduction, and ESG consideration in the current bioprocess development, WuXi Biologics has developed WuXiUITM, offering flexible and cost-effective bioprocessing solutions for global clients. Compared with the conventional fed-batch bioprocesses, WuXiUITM applies an innovative ultra-intensified intermittent-perfusion fed-batch (UI-IPFB) strategy in upstream production to realize a 3 to 6-fold increase in productivity in a typical culture duration of 14 days for a fed-batch process – for different molecule modalities such as mAbs, bispecifics and recombinant proteins – while ensuring desirable product quality. For example, by leveraging WuXiUITM, the titer of a bispecific antibody achieved 25 g/L in 14 days – 5 times higher than the same-scale traditional fed-batch process – with expected product quality.
WuXiUITM reduces drug substance manufacturing COGS by an estimated 60-80% compared to traditional fed-batch processes in single-use bioreactors, enhancing the competitiveness of commercial products. The platform is also easily adopted and can be scaled up/out in existing facilities without additional requirements for major equipment or complex operations, bringing minimum changes to the downstream process. Adhering to WuXi Biologics' ESG strategy, WuXiUITM has a lower carbon footprint than traditional or other intensified fed-batch processes due to more efficient media consumption and reduced waste generation.
Dr. Chris Chen
CEO
WuXi Biologics
We are pleased to launch the WuXiUI™ platform to provide diverse bioprocessing solutions for global clients that enhance productivity and product quality, and tremendously reduce product COGs. WuXi Biologics' continual launch of new technology platforms comes from our drive to push boundaries and foster innovation – all with the goal of enabling our global partners to bring more high-quality and affordable biologics to patients worldwide.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2023, WuXi Biologics is supporting 621 integrated client projects, including 22 in commercial manufacturing.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
注:本信息不构成药明生物的信息披露或投资建议

