WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of WuXiHigh™2.0, a high-throughput formulation development platform designed for high concentration biologics. The platform enables protein concentrations of up to 230mg/mL and achieves viscosity reduction by up to 90%..

药明生物（2269.HK），全球领先的合同研究、开发和生产组织（CRDMO），今日宣布推出高通量制剂开发平台WuXiHigh™2.0，专为高浓度生物制品设计。该平台可实现高达230mg/mL的蛋白浓度，并将粘度降低多达90%。

High-concentration biologics, typically defined as formulations exceeding 100mg/mL protein, offer advantages including reduced injection volume, improved dosing efficiency and enhanced patient adherence. They have increasingly emerged as a critical R&D priority for pharmaceutical companies. Currently, over 20% of monoclonal antibody products approved by the U.S.

高浓度生物制品通常定义为蛋白质浓度超过 100 mg/mL 的制剂，其优势包括减少注射体积、提高给药效率以及增强患者的依从性。它们日益成为制药公司关键的研发重点。目前，美国批准的单克隆抗体产品中，超过 20% 属于这一类别。

Food and Drug Administration (FDA) are high-concentration formulations. However, the development and manufacturing of such formulations often suffer from high viscosity and aggregation, which can complicate manufacturing, compromise product stability and increase risks of immunogenicity..

食品和药物管理局（FDA）的高浓度制剂。然而，此类制剂的开发和生产常常受到高粘度和聚集的影响，这可能会使生产复杂化，影响产品稳定性并增加免疫原性风险。

The highest formulation concentration documented in FDA-approved biologics is 200mg/mL. The WuXiHigh™2.0 technology platform enables concentration levels of up to 230mg/mL by leveraging the company’s proprietary excipient blends and expertise. The significantly enhanced concentration translates to greater flexibility in injection volume, reduced dosing frequency, and simplified cold-chain logistics, while boosting drug substance manufacturing and drug product manufacturing efficiency.

FDA批准的生物制品中记载的最高制剂浓度为200mg/mL。WuXiHigh™2.0技术平台通过利用公司专有的辅料配方和专业知识，可实现高达230mg/mL的浓度水平。显著提升的浓度意味着注射体积更灵活、给药频率降低、冷链物流简化，同时提高了原料药生产和制剂生产的效率。

By deploying over 24 proprietary excipient combinations, the platform substantially reduces viscosity by up to 90% while maintaining formulation stability and injectability..

通过部署超过24种专有的辅料组合，该平台在保持配方稳定性和可注射性的同时，最多可将粘度降低90%。

Additionally, WuXiHigh™2.0 integrates high-throughput instruments to predict viscosity and aggregation risks. This rapid, data-driven approach enables smarter excipient selection from the earliest formulation stages, accelerating development timelines and minimizing material consumption. The platform supports ultrafiltration/diafiltration (UF/DF) operations at viscosities up to 100 cP and precision filling at up to 50 cP, ensuring seamless technology transfer and scale-up—from early clinical development to commercial manufacturing..

此外，WuXiHigh™2.0整合了高通量仪器以预测粘度和聚集风险。这种快速、数据驱动的方法能够从最早的研发阶段进行更明智的辅料选择，加快开发进程并减少材料消耗。该平台支持在高达100厘泊(cP)的粘度下进行超滤/透析(UF/DF)操作，并在高达50厘泊(cP)的精度下进行灌装，确保从早期临床开发到商业化生产的无缝技术转移和放大。

Dr. Chris Chen, CEO of WuXi Biologics, commented, “WuXiHigh™2.0 represents a transformative technology platform for next-generation biologics with high-concentration formulations. Its ability to enhance concentration while reducing viscosity redefines industry benchmarks, and more importantly elevates patient experience without compromising drug efficacy.

药明生物首席执行官陈智胜博士评论道：“WuXiHigh™2.0代表了一个用于下一代高浓度配方生物药的变革性技术平台。它在提高浓度的同时降低粘度的能力重新定义了行业标准，更重要的是，在不妥协药物疗效的情况下提升了患者体验。”

We remain committed to integrating innovative science with deep expertise in drug product formulation, enabling our clients to efficiently accelerate development and deliver therapies to patients worldwide.”.

我们仍然致力于将创新科学与药物产品配方的深厚专业知识相结合，使我们的客户能够高效地加速开发并将疗法带给全球患者。

About WuXi Biologics

关于药明生物

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..

无锡生物制品（股票代码：2269.HK）是全球领先的合同研究、开发和生产组织（CRDMO），提供端到端的解决方案，使合作伙伴能够从概念到商业化发现、开发和生产生物制品，造福全球患者。

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)..

药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12,000名技术员工，利用其技术和专业知识为客户提供高效且具成本效益的生物制品发现、开发和生产解决方案。截至2024年12月31日，药明生物正在支持817个综合客户项目，其中包括21个商业化生产项目（不包括新冠CMO项目）。

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).

药明生物将可持续发展视为企业长期发展的基石，不断推动绿色技术创新，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时持续在环境、社会及治理（ESG）方面追求卓越。

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..

致力于创造共享价值，与所有利益相关者合作，促进积极的社会和环境影响，并推动负责任的实践，赋能整个价值链。

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

有关药明生物的更多信息，请访问：www.wuxibiologics.com。

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Source: wuxibiologics.com

来源：wuxibiologics.com