Streamline Analysis and Enhance Detection with LC-MS Multiple Attribution Monitoring
Multiple analytical assays are currently used for product quality attribute (PQA) monitoring and product purity testing throughout biotherapeutic development and production. As regulatory requirements continue to evolve and expand, researchers are increasingly pressured to provide more detailed information on the biologic product, while speeding development times.
A Multiple-Attribute Methodology (MAM) using accurate mass LC-MS can directly monitor more PQAs in a single sample analysis than other conventional characterization methods. Using a single MAM LC-MS assay can reduce the overall analytical testing burden during development while gaining a more complete analysis of the product quality profile.
The SCIEX streamlined Workflow for MAM utilizes powerful, accurate mass QTOF technology and BioPharmaView™ Software 3.0 for PQA monitoring, while concurrently monitoring known impurities and detecting new, unspecified impurities. This single software solution makes developing and implementing a MAM LC-MS assay simple and intuitive to do while enhancing the characterization of your biotherapeutic.