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WuXi Biologics Launches Next-Generation Platform WuXiHigh™2.0 for High-Concentration Biologics with Protein Concentration Reaching 230 mg/mL
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%.
About this update from Wuxi Biologics (cayman) Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"The WuXiHigh™2.0 technology platform harnesses proprietary excipient blends and expertise to enable concentrations up to 230 mg/mL","length":130,"tagName":"p"}]},{"val":[{"type":"text","content":"It reduces viscosity by up to 90% while maintaining formulation stability and injectability","length":91,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":221,"olType":false},{"type":"text","content":"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%.","length":402,"tagName":"p"},{"type":"text","content":"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.","length":658,"tagName":"p"},{"type":"text","content":"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.","length":669,"tagName":"p"},{"type":"text","content":"Additionally, WuXiHigh™2.0 integ...