Prospects and current use of the multi-attribute method for quality control of therapeutic antibodies

In recent years therapeutic proteins products including therapeutic antibodies have become a major driving force for the modern biopharmaceutical industry. However, they have complex product quality attributes (PQAs) which limit product development and quality control (QC). Recent advances in high resolution mass spectrometry (MS) have led to the use of an MS-based multi-attribute method (MAM) for quality control testing of therapeutic proteins, which allows for direct measurement of multiple PQAs and identification of impurities. MAM helps to promote the improvement of product quality and QC and a reduction in manufacturing cost. To explore the application of MAM in QC, we discuss generic MAM workflow, the current state of MAM application in product development and QC, identify points to consider for use of MAM as a QC test, and summarize MAM's advantages and challenges in this article. The future application of MAM for therapeutic antibodies and the opportunities for its further development, use, and substitution for conventional methods is presented.