Streamlined characterization and monitoring of biopharmaceuticals using a multiple attribute methodology (MAM) workflow

摘要

The use of LC-MS can be a valuable tool, not just for characterization of biologies, but increasingly for monitoring attributes throughout the entire process. This multiple attribute methodology comprises monitoring of critical quality attributes as well as monitoring known and unknown impurities using a new peak detection analysis. The addition of this orthogonal assay to characterization and monitoring of biotherapeutics is the speed at which the analysis can be performed and the information that can be leamed.This technology and its implementation align with both ICH and FDA guidelines towards quality by design (QbD) which involves monitoring of biotherapeutics throughout the production and into final processing, ensuring product quality. Here we discuss implementation of MAM for biotherapeutics.