Holistic Strategy for High Concentration Monoclonal Antibody Formulations

WEBINAR

High-concentration protein therapeutics, e.g. monoclonal antibodies, are considered as alternative and convenient application routes for injectables. Such formulations can be attained through optimization of formulation buffer to reduce viscosity, ultrafiltration device design to accommodate higher viscosity streams, and system design to allow low shear and low volume processing. In this pilot-scale study, we demonstrate the impact of optimized cassette design and the use of single-pass TFF (SP-TFF). Combining these approaches with excipients from the Viscosity Reduction Platform, concentration limits could be significantly pushed (> 300g/L) and protein stability was maintained.