Single Pass TFF as a Tool to Achieve a High Concentration mAb Formulation

High concentration monoclonal antibody (mAb) formulations enable subcutaneous administration but often present challenges during downstream concentration using batch tangential flow filtration (TFF), which can include elevated feed pressures, shear, and yield loss at high viscosity. Single-Pass TFF (SPTFF) was evaluated as a process strategy to achieve a target concentration of ≥200 g/L, while also mitigating the challenges of traditional batch TFF. For this study a humanized IgG1 mAb was produced in FUJIFILM Biotechnologies ApolloX™ CHO expression system and purified via FUJIFILM Biotechnologies mAb downstream purification platform. Results indicate SPTFF with Pellicon® Capsules as a viable, scalable approach for high concentration mAb formulations within the FUJIFILM Biotechnologies’ mAb purification platform. To learn more download this white paper.