WuXi Biologics Launches Next-Generation Platform WuXiHigh™2.0 for High-Concentration Biologics with Protein Concentration Reaching 230 mg/mL

Rhea-AI Summary

WuXi Biologics (WXXWY) has launched WuXiHigh™2.0, an advanced formulation development platform for high-concentration biologics. The platform achieves protein concentrations up to 230 mg/mL, surpassing the current FDA-approved maximum of 200 mg/mL, while reducing viscosity by up to 90%.

The technology leverages proprietary excipient blends and integrates high-throughput instruments to predict viscosity and aggregation risks. It supports ultrafiltration/diafiltration operations at viscosities up to 100 cP and precision filling at up to 50 cP. The platform addresses the growing demand for high-concentration biologics, which currently represent over 20% of FDA-approved monoclonal antibody products.

Positive

• None.

Negative

• High viscosity and aggregation challenges in high-concentration formulations can increase immunogenicity risks
• Complex manufacturing process requiring specialized conditions for ultrafiltration/diafiltration operations

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• The WuXiHigh™2.0 technology platform harnesses proprietary excipient blends and expertise to enable concentrations up to 230 mg/mL
• It reduces viscosity by up to 90% while maintaining formulation stability and injectability

SHANGHAI, June 30, 2025 /PRNewswire/ -- 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 230 mg/mL and achieves viscosity reduction by up to 90%.

High-concentration biologics, typically defined as formulations exceeding 100 mg/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. 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.

The highest formulation concentration documented in FDA-approved biologics is 200 mg/mL. The WuXiHigh™2.0 technology platform enables concentration levels of up to 230 mg/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. By deploying over 24 proprietary excipient combinations, the platform substantially reduces viscosity by up to 90% while maintaining formulation stability and injectability.

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.

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. 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."

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.

Contacts

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info@wuxibiologics.com 

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PR@wuxibiologics.com

FAQ

What is WuXi Biologics' new WuXiHigh™2.0 platform and what does it achieve?

WuXiHigh™2.0 is a high-throughput formulation development platform that enables protein concentrations up to 230 mg/mL and reduces viscosity by up to 90% for high-concentration biologics.

How does WuXiHigh™2.0 compare to current FDA-approved biologics concentrations?

WuXiHigh™2.0 achieves concentrations up to 230 mg/mL, exceeding the highest FDA-approved biologic concentration of 200 mg/mL.

What are the manufacturing capabilities of WuXi Biologics' WuXiHigh™2.0 platform?

The platform supports ultrafiltration/diafiltration operations at viscosities up to 100 cP and precision filling at up to 50 cP, enabling seamless technology transfer from clinical to commercial manufacturing.

What percentage of FDA-approved monoclonal antibody products are high-concentration formulations?

Currently, over 20% of FDA-approved monoclonal antibody products are high-concentration formulations.

What are the patient benefits of WuXi Biologics' WuXiHigh™2.0 platform?

The platform enables reduced injection volume, improved dosing efficiency, and reduced dosing frequency, leading to enhanced patient adherence.