Application note: Enabling single-software multiple attribute methodology (MAM) for the assessment of biopharmaceutical product quality attributes

Development and production of biopharmaceuticals is complex. Even minor impurities, or changes in attributes such as glycosylation or charge heterogeneity, can have a profound impact on the safety and efficacy of the final product. Traditionally, multiple analytical techniques have been required to assess the full range of biopharmaceutical product attributes. But the inevitable consequence of multiple analytical techniques is greater expenditures of time and resources.