Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors. Outlined here is a two-method solution to evaluate one such excipient (PS-80) for quantity and quality.
Characterization of trace elements is important for upstream process development and batch quality control. This poster outlines a strategy using inductively coupled plasma-mass spectrometry (ICP-MS) to conduct trace-level multiple analysis.
Fc receptors are widely distributed cell-surface proteins that are essentially communication points between effector antibodies and their biological implements. Learn how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.
Determining size homogeneity of a monoclonal antibody in solution is important for comparability and characterization of these medications. For this study, an IgG antibody was cleaved into antigen-binding fragments using pepsin and papain digestion, followed by protein purification.