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WuXia293Stable平台具备显著优势，可大幅提升蛋白表达量，实现完整人源糖基化，还能最大化地降低或避免复杂难表达分子中常见的蛋白质截短或断裂问题，从而显著提升产品质量
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WuXia293Stable细胞株在长期传代培养期间，始终保持稳定的表达水平与产品质量，助力实现不同规模的临床和商业化生产
上海，
2025年8月11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）今日宣布推出全新的 WuXia293Stable平台。该平台利用HEK293细胞，可稳定表达复杂生物药分子，显著提升细胞株表达量、稳定性和产品质量，从而进一步强化CMC开发和生产优势，为结构和功能更为复杂的创新药研发及生产提供高效解决方案。
长期以来，CHO 细胞被广泛应用于重组蛋白表达，在表达量、可开发性和可生产性方面表现优异。然而，面对结构和功能更为复杂的分子，CHO细胞表达平台也会遇到难以匹配的挑战，不仅表达量低，由于CHO细胞中特有的宿主细胞蛋白，还容易出现蛋白质截短或断裂问题，严重影响产物的质量和有效性。相比之下，HEK293 细胞在复杂分子表达方面独具优势，在实现高表达量的同时能最大化地降低或避免蛋白质截短或断裂风险。
药明生物依托其专有的HEK293宿主细胞株成功开发了WuXia293Stable平台。该平台衍生于药明生物成熟的高产哺乳动物细胞株构建系列平台WuXia™，不仅与WuXia™平台工艺全面兼容，还延续了WuXia™平台高产量、高质量和高稳定性等卓越性能，实现稳健的细胞生长和平衡的细胞代谢。
WuXia293Stable的单克隆抗体分批补料表达量高达5.0克/升，同时产物纯度得到显著提升。在细胞培养规模上，该平台具备高度灵活性以满足不同阶段的研发需求。值得一提的是，WuXia293Stable细胞株在长期传代培养过程中，始终保持稳定的表达水平和高质量，在分批补料培养模式下，可实现2000升规模的临床和商业化生产，灌流培养模式下也能实现1000升的生产规模。除此之外，药明生物还配套推出针对WuXia293Stable平台的细胞库检测服务和病毒清除验证服务，真正实现一站式的CMC解决方案。
WuXia293Stable平台的推出，进一步增强了药明生物WuXia™系列平台的服务能力。除WuXia293Stable以外，WuXia™平台已衍生出WuXiaADCC Plus™和WuXia RidGS™等细胞株构建平台，满足客户多元化的需求。
陈智胜
博士
药明生物首席执行官
很高兴看到WuXia™细胞株构建系列平台再添一员。WuXia293Stable平台将为前沿创新疗法研发提供高效、优质的解决方案，也是我们践行‘让天下没有难做的生物药’愿景的切实成果。该平台还彰显了药明生物以技术创新为驱动，持续响应生物制药行业多样化需求，全方位赋能客户，加速推动创新生物药惠及全球患者的坚定承诺。
关于WuXia™细胞株构建系列平台
WuXia™是药明生物开发的高产哺乳动物细胞株构建系列平台，产量最高可达11g/L。该系列平台已获得全球药品监管机构的认可，截至2024年已开发超过1000个表达单克隆抗体、双特异性抗体、融合蛋白、酶和其他重组蛋白的细胞株，用于临床和商业化生产。
WuXia™系列平台目前包括：WuXiaADCC Plus™，用于开发和生产无岩藻糖基化抗体，以增强抗体依赖性细胞介导的细胞毒性（ADCC）效应；WuXia RidGS™，用于非抗生素筛选的细胞株开发；以及最新的WuXia293Stable，基于 HEK293 细胞系，赋能复杂药物分子研发与生产。WuXia™系列平台持续拓展，以满足全球客户的多元化需求。
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）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2024年12月底，药明生物帮助客户研发和生产的综合项目高达817个，其中包括21个商业化生产项目（不包括新冠项目）。
药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时在ESG方面不断取得卓越成就。秉承创造共享价值的理念，公司携手利益相关方构建可持续发展生态，通过负责任运营模式推动社会价值与生态效益双提升，实现全价值链的协同赋能。更多信息，请访问：www.wuxibiologics.com
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WuXi Biologics Launches HEK 293 Stable Cell Line Platform WuXia293Stable for Development and Manufacturing of Difficult-to-Express Molecules
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WuXia293Stable platform demonstrates high titer, human glycosylation and improved product quality by eliminating or significantly alleviating truncation in difficult-to-express molecules
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WuXia293Stable platform maintains stable expression and consistent product quality during long-term cell passages, enabling scalable clinical and commercial manufacturing
Shanghai
August 11, 2025
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of WuXia293Stable, a new platform designed for the development and manufacturing of innovative, difficult-to-express molecules that are stably expressed in HEK293 cells. The platform, which demonstrates high titers, robust stability and superior quality, significantly enhances the developability and manufacturability of these molecules, offering a highly efficient CMC solution for biologics that are sophisticated in both structure and function.
Conventionally, CHO cells have been widely utilized for recombinant protein expression with proven track record of high titers, and good developability and manufacturability. However, complex modalities may not be compatible with CHO expression system, resulting in low titer levels and truncation issues, due to the impact of some CHO-specific host cell proteins (HCPs), that compromise the quality and functionality of the protein products. In contrast, HEK293 cells can eliminate or significantly alleviate truncation issues in expressing complex molecules while maintaining high titer levels.
WuXi Biologics developed WuXia293Stable by leveraging its proprietary HEK293 cell line. Derived from WuXi Biologics' highly-vetted mammalian cell line development platform family WuXia™, WuXia293Stable demonstrates productivity，quality and stability comparable to WuXia™ while maintaining full compatibility with its process, as shown by its robust growth and balanced metabolism.
The platform achieves a fed-batch titer of up to 5.0 g/L for monoclonal antibodies while significantly improving purity. WuXia293Stable offers flexible scalability in culture scale to meet the diverse needs of various research and pre-clinical development stages. Furthermore, the WuXia293Stable cell line maintains stable expression and consistent quality during long-term cell passages, enabling scalable clinical and commercial manufacturing at 2000L scale for fed-batch and 1000L scale for perfusion. Moreover, WuXi Biologics offers a comprehensive suite of services for the WuXia293Stable platform, including cell bank testing and viral clearance validation as part of its one-stop CMC solution.
The launch of the WuXia293Stable platform has further strengthened the service capabilities of WuXi Biologics' WuXia™ platform family. Besides WuXia293Stable, the WuXia™ platform has already derived multiple cell line development platforms, including WuXiaADCC Plus™ and WuXia RidGS™, to address customers' diverse requirements.
Dr. Chris Chen
Chief Executive Officer
WuXi Biologics
We are excited to launch an industry-leading solution that significantly enhances the development of advanced therapeutics. WuXia293Stable stands as a powerful testament to WuXi Biologics' unwavering commitment to our vision that every biologic can be made and exemplifies our dedication to technological innovation, which enables us to adeptly address the evolving needs of the biopharmaceutical industry. Once again we are reaffirming our promise to enable our clients in accelerating the delivery of innovative biologics to patients worldwide.
About the WuXia™ Cell Line Development Platform Family
WuXia™ is a proven, high-yield (up to about 11 g/L) mammalian cell line platform family developed by WuXi Biologics. Accepted by regulatory agencies worldwide, the WuXia™ platform family have generated over 1000 cell lines expressing monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins for clinical and commercial manufacturing as of 2024.
The WuXia™ platform family include WuXiaADCC Plus™ for developing and manufacturing afucosylated antibodies to elicit an enhanced ADCC response, WuXia RidGS™ for non-antibiotic cell line development, and the latest WuXia293Stable for expressing difficult-to-express molecules built on HEK293 cell lines. The WuXia™ cell line development platform family continue to expand to cater to the diverse needs of global customers.
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 December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).
WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com
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