Abstract
Therapeutic monoclonal antibodies （mAbs） undergo several modifications including deamidation, isomerization, oxidation and glycosylation during cell culture, purification, formulation and storage. Some modifications are associated to biological activities, pharmacokinetics, and stability of mAbs. To ensure quality of mAbs it is important to establish control strategy ensuring that the structural properties, of which the change has potential impacts on efficacy or safety, are within an appropriate limit, range or distribution. Structural evaluation methods for mAbs using several chromatographic techniques have been successfully established to date. However, many of these conventional methods usually only evaluate a kind of quality attribute of mAbs, and therefore, complicated and time-consuming multiple tests have been required to perform for a comprehensive characterization of mAbs. Currently, integration and simplification of the multiple tests is in the spotlight in the biopharmaceutical industry. A quantitative characterization method called multi-attribute method （MAM） by peptide mapping technique using liquid chromatography/high resolution mass spectrometry is attracting attention in lieu of the conventional methods. MAM can provide detailed qualitative and quantitative information about the multiple structural aspects, and process and product-related impurities by only single measurement. Recently, several MAM solutions have been provided by mass spectrometer and software vendors, and is gradually becoming popular in regulatory authorities as well as the industry. This article provides brief review of common modifications of mAbs, overview and issues of MAM, and the current status of MAM analysis.
