SPTFF High Concentration mAb Formulation Case Study

Chris Marlein, Senior Principal Scientist, FUJIFILM Biotechnologies Contributors: Matthew Dillingham, Evie Wood, Pavan Kalmesh, Sean Chambers, Louise Relph, Luke Pallis, Kenneth Holbourn, Sam Maurice FUJIFILM Biotechnologies

Achieving high-concentration monoclonal antibody (mAb) formulations presents persistent challenges, from viscosity management to maintaining stability and product quality. Single-pass tangential flow filtration (SPTFF) offers a streamlined approach to concentration and buffer exchange, enabling efficient processing while minimizing shear stress and overall processing time. By integrating SPTFF into formulation workflows, teams can improve throughput, enhance scalability, and reduce the need for multiple unit operations.

This case study highlights how SPTFF supports the development of high-concentration mAb formulations, addressing common bottlenecks associated with conventional methods. Key considerations include optimizing process parameters, preserving protein integrity, and ensuring reproducible performance across scales. For teams focused on accelerating biologics development, exploring this approach can unlock new efficiencies and improve formulation outcomes.

Dive deeper to see how SPTFF can be effectively applied to meet demanding concentration targets.