The rapid growth of biotherapeutic industry, with more and more complex molecules entering the market, forces the need for advanced analytical platforms that can quickly and accurately identify and quantify product quality attributes. Mass spectrometry has the potential to provide more detailed information about the quality attributes of complex products, and MS methods are more sensitive than UV methods for detection of impurities. The multi-attribute method (MAM), a liquid chromatography-mass spectrometry based analytical approach is an emerging platform which supports biotherapeutic characterization and cGMP testing. The main advantage lies in the ability to monitor multiple quality attributes in a single assay, both at the peptide and the intact level, facilitating streamlined biopharmaceutical production, from research and development to the QC environment. This review highlights the current landscape of the MAM approach with special attention given to increased analytical throughput, general requirements for QC in terms of instrumentation and software, regulatory requirements, and industry acceptance of the MAM platform.
Keywords: Biotherapeutics; HRAM; NPD; QC; critical quality attributes; multi-attribute method.