Advancing Mass Spectrometry Technology in cGMP Environments

Abstract

Mass spectrometry is a powerful analytical tool that has been widely used in the biotech industry. Recent trends of implementing a liquid chromatography-mass spectrometry (LC-MS) based multi-attribute method (MAM) in cGMP environments enables end-to-end monitoring and control of critical quality attributes (CQAs) of therapeutic proteins to ensure drug product quality.

Keywords: critical quality attributes (CQAs); current good manufacturing practice (cGMP); liquid chromatography-mass spectrometry (LC-MS); multi-attribute method (MAM); quality by design (QbD); therapeutic proteins.