In the development of biotherapeutics, a thorough understanding of a molecule’s product quality attributes (PQAs), and their effect on structure-function relationships and long-term stability, is key for ensuring the safety/efficacy of the product. At present, numerous routine chromatographic and electrophoretic assays are used to characterize and monitor individual PQAs for batch release, stability time-points and process/formulation development support. However, execution of multiple routine methods is time/resource intensive and often provides an indirect measure of biologically-relevant PQAs. Learn about an MS-based multi-attribute method (MAM) “Lab-of-the-Future,” that provides concurrent detection, identification, quantitation and quality control (monitoring) of PQAs.
