Reliable Osmolality Testing of High Concentration mAb Formulations
Osmolality testing has several unique and essential applications throughout bioprocessing, and new use cases are constantly emerging. As the field of biologics manufacturing matures, osmometers and other analytical devices must keep up and even offer new options to remain valuable. The osmolality of monoclonal antibody (mAb) formulations is typically determined using freezing point depression or vapor pressure osmometers. This paper details an evaluation of the OsmoTECH® XT (freezing point) and Vapro® 5600 (vapor pressure) osmometers as a means of measuring concentrated protein formulations.