(466d) Prediction of Viral Filtration Performance of Monoclonal Antibodies Based On Dynamic Light Scattering Analysis

Abstract:  Controlling viral contamination is an important issue in the process development of monoclonal antibodies (MAbs).  For FDA submissions, it is recommended that purification processes show a total reduction of model viruses greater than the maximum possible virus titer that could potentially occur in the fermentation material to assure viral safety of the purified biological bulk.  Virus filtration (VF) is a major clearance step which can provide ≥5 logs of reduction via size-exclusion, albeit they are single-use and often represent ~10% of total purification costs.  Therefore, it is important to be able to minimize VF area by increasing flux and filter loading during development studies. Development work was executed to achieve a streamlined (i.e. cost- and time-effective) virus filtration process.  This presentation will summarize improvements from this work using a model MAb program as a case study, and will show how changes in feed composition (mAb concentration, pH, NaCl, type) can change zeta potential and Z_ave, which can predict a trend in VF performance through modeling of the flux curves and DLS analysis.