Whitepaper: Enabling single-software multiple attribute methodology (MAM) for 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 production of the biotherapeutic, as well as unknown impurities (new peaks) present in samples but not in corresponding standards.
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