High throughput formulation development platform for high concentration biologics drug products
The WuXiHighTM platform provides customized biologics formulation development strategies for high concentration drug products (up to 200 mg/mL). The platform can be applied to a variety of biological modalities, such as monoclonal, bispecific and multispecific antibodies, fusion proteins, and other recombinant proteins. Its distinctive viscosity reducers and synergistic excipient combinations enhance formulation stability and reduce viscosity. As an industry-leading high concentration drug product (DP) development platform, WuXiHigh integrates advanced computer simulation technologies like homologous modeling, molecular dynamics simulation, and machine learning. Through this integration, formulation development is achieved more efficiently and with less risk by leveraging computational simulation results, high-throughput experimental screening, and experimental verification.
To enable efficient protein characterization, the platform is equipped with high-throughput equipment including UNcle, HT-DLS, Rheosense, as well as novel technologies such as LF-NMR. WuXiHigh also offers tailored process development and technology transfer strategies for drug substance (DS) and drug product (DP) across a wide range of viscosities (up to 21.5 cP). Additionally, the platform facilitates the development, production, assembly and fill of prefilled syringes and autoinjectors. With a wealth of experience from over 70+ projects in high concentration formulation development and manufacturing, the platform has acquired significant expertise and a knowledge database, allowing us to provide comprehensive end-to-end formulation and drug product development services to our global clients.