Optimization of SPTFF for high concentration applications

The number of monoclonal antibodies (mAbs) with high-concentration formulation is expected to grow annually by 13% between 2024 and 2029. Meeting this demand in drug manufacturing brings unique challenges: lower production volume means that every drop is precious and product recovery must be maximized, and higher drug product viscosity and the need to minimize protein aggregation can make efficient processing difficult.

Here we present a case study of a 50 L scale high-concentration mAb process (> 200 g/L), utilizing single-pass TFF for final concentration, including subsequent optimization to minimize protein aggregation.

Speaker
Sandeep Kristiansson