Presentation Description: Knowledge on the stability of therapeutic proteins in vivo, i.e., after administration to patients, is limited. This talk aims to discuss the relevance of in vitro studies to assess the stability of therapeutic proteins under simulating physiologic conditions. In vivo degradation of a therapeutic protein may alter treatment efficacy and/or patient safety . Moreover, in vitro studies can support the selection of better molecules in early stages of pharmaceutical development. In our study, we compared the physical stability of 8 different monoclonal antibodies (mAbs) in phosphate-buffered saline (PBS) and human serum. mAbs were characterized with respect to fragmentation, aggregation, and proteinaceous particle formation. All mAbs were inherently less stable in human serum as compared to PBS. Particle size and counts increased in serum over time and certain mAbs showed substantial levels of fragmentation in serum but not in PBS.
Upon completion, participants will be able to discuss different analytical strategies to assess the in vivo stability of therapeutic proteins.
Upon completion, participants will be able to discuss analytical challenges associated with biological fluids such as human serum.
Upon completion, participants will be able to define key factors of human biofluids potentially impacting the stability of therapeutic proteins.