WuXi Biologics Launches WuXiHigh™ 2.0 to Advance High-Concentration Biologic Formulations
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has announced the official launch of WuXiHigh™ 2.0, a next-generation, high-throughput formulation development platform specifically engineered for high-concentration biologics. This upgraded platform is capable of achieving protein concentrations up to 230 mg/mL, surpassing the current industry benchmark and addressing key formulation challenges such as excessive viscosity and instability.
Meeting the Growing Demand for High-Concentration Biologics
High-concentration biologics—generally defined as injectable formulations with protein concentrations exceeding 100 mg/mL—have become a strategic priority for many pharmaceutical developers. These formulations offer substantial benefits including reduced injection volume, more convenient dosing, enhanced patient compliance, and improved self-administration potential, especially for chronic conditions. Currently, more than 20% of FDA-approved monoclonal antibodies (mAbs) fall into this category, reflecting a growing industry trend.
Despite these benefits, the development and commercialization of high-concentration biologics come with formidable challenges. High viscosity, aggregation risks, and stability issues often complicate both upstream and downstream processes, including manufacturing, packaging, and storage. Moreover, these factors may affect drug safety and efficacy by increasing the likelihood of immunogenic responses.
WuXiHigh™ 2.0: Pushing the Boundaries
With WuXiHigh™ 2.0, WuXi Biologics sets a new standard in the formulation of biologics by enabling concentration levels up to 230 mg/mL, a significant leap beyond the previous high mark of 200 mg/mL seen in FDA-approved products. This is made possible through the company’s proprietary formulation science, including the strategic use of over 24 optimized excipient combinations that significantly reduce viscosity by up to 90% without sacrificing product integrity.
This improvement translates into key operational and clinical benefits:
- Increased formulation flexibility to support lower injection volumes and reduced dosing frequency
- Improved cold-chain logistics due to more stable formulations
- Enhanced manufacturing efficiency at both the drug substance and drug product levels
Integrated Technologies for Smarter, Faster Development
Beyond formulation improvements, WuXiHigh™ 2.0 incorporates high-throughput analytical tools and data-driven predictive modeling to assess viscosity and aggregation risks early in the development process. These capabilities allow for smarter excipient selection, more efficient formulation screening, and significantly accelerated development timelines.
The platform also supports ultrafiltration/diafiltration (UF/DF) operations at viscosities up to 100 cP and precision drug product filling at up to 50 cP, ensuring scalability from preclinical development to full commercial production. This seamless transition capability minimizes technical transfer risks and shortens time-to-market for biologic candidates.
Industry Impact and Leadership Vision
Dr. Chris Chen, CEO of WuXi Biologics, emphasized the platform’s transformative potential:
“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.”
