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WuXi Biologics Launches Next-Generation Platform WuXiHigh™2.0 for High-Concentration Biologics with Protein Concentration Reaching 230 mg/mL
Prnewswire· 2025-06-30 11:00
Core Insights - WuXi Biologics has launched WuXiHigh™2.0, a high-throughput formulation development platform for high concentration biologics, enabling protein concentrations of up to 230 mg/mL and viscosity reduction by up to 90% [1][3][10] Industry Context - High-concentration biologics, defined as formulations exceeding 100 mg/mL protein, are increasingly prioritized in R&D by pharmaceutical companies due to benefits like reduced injection volume and improved dosing efficiency [2] - Over 20% of monoclonal antibody products approved by the FDA are high-concentration formulations, highlighting their growing significance in the market [2] Technological Advancements - The WuXiHigh™2.0 platform utilizes proprietary excipient blends to achieve higher concentration levels than the current FDA-approved maximum of 200 mg/mL, enhancing manufacturing efficiency and simplifying logistics [3][5] - The platform integrates high-throughput instruments to predict viscosity and aggregation risks, facilitating smarter excipient selection and accelerating development timelines [4] Operational Efficiency - WuXiHigh™2.0 supports ultrafiltration/diafiltration operations at viscosities up to 100 cP and precision filling at up to 50 cP, ensuring effective technology transfer from clinical development to commercial manufacturing [4] Company Commitment - WuXi Biologics emphasizes its commitment to innovative science and deep expertise in drug product formulation, aiming to enhance patient experience while maintaining drug efficacy [5]