Stability of monoclonal antibodies after simulated subcutaneous administration

Changes in the environment from drug product to human physiology might lead physical and/or chemical modifications of protein drug, such as vivo aggregation and fragmentation. Although subcutaneous (SC) injection is a common route administration for therapeutic proteins, knowledge on stability SC tissue limited. In this study, we developed physiologic vitro model simulating patients. We assessed two monoclonal antibodies (mAbs) four different protein-free fluids under conditions. monitored over weeks using range analytical methods, analogy testing purposes product. Both mAbs showed an increase aggregates, fragments, acidic species. mAb1 was consistently more stable than mAb2, highlighting importance comparing Throughout both were substantially less bicarbonate buffers compared phosphate-buffered saline. summary, our able differentiate between molecules. Bicarbonate suitable saline regards conditions evaluating liabilities.