Webinar: Enhanced Characterization of Particulates Generated in Tangential Flow Filtration (TFF) mAb Processing

Drug product formations are routinely exceeding 150 mn/ml with the prevalence of administration by subcutaneous injection. These high mAb concentrations and associated increased solution viscosities present new challenges to traditional drug substance TFF manufacturing hardware, analytical measurements, and process performance at scale.

Challenges include recovery of concentrated intermediate from large skids, sampling, and testing very viscous intermediate fractions, potential product quality risks during processing, and filter fouling during subsequent 0.2 µm filtration. Engineering strategies to reduce TFF skid hold up volume and minimize process impact at high mAb concentrations can be implemented to improve overall step recovery and minimize aggregation.

In addition to the engineering improvements, this presentation will demonstrate how integrated, inline PAT such as Infrared/Raman and retentate particle measurements, can be used to mitigate these new processing challenges. These PAT tools enable scientists to evaluate their process in real time and guide the scale-up of process conditions and 0.2 µm filter sizing. The results from two successful reduced-scale studies using these PAT to enhance characterization will also be discussed, highlighting both opportunities and challenges in the areas of high-concentration TFF control.