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.
The multiple attribute methodology (MAM), an orthogonal approach based on peptide map separation coupled with high-resolution mass spectrometry, is rapidly emerging as a powerful tool for characterisation and monitoring of biopharmaceutical attributes. The range of attributes that can be monitored using this approach is extensive. MAM can be used to assess, track, and provide detailed data on multiple, specific biologic product quality attributes at the peptide level.
In addition to tracking the therapeutic molecule itself, MAM can be used to detect known impurities related to the production of biotherapeutics, as well as unknown impurities (new peaks) present in samples but not in corresponding standards.
Essential to the successful implementation of a MAM workflow is software that can manage all aspects of the workflow, including product quality attribute (PQA) definition, tracking, and quantification; detection of known and unknown impurities; and reporting.