Long Term Stability Analysis of Monoclonal Antibodies

Long Term Stability Analysis of Monoclonal Antibodies Overview Characterization of biopharmaceuticals during all development phases is critical to the candidate selection process and the ongoing production of the active material. Some recent efforts to achieve patient self-administration has required high API concentrations (100-300 mg/mL). Development concerns for the high concentration formulations are denaturation, aggregation and…