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

December 11, 2018

Development and production of biopharmaceuticals are complex. Even minor impurities, orchanges in attributes such as glycosylation or charge heterogeneity, can have a profound impact on the safety and = ef cacy of the nal 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.

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Real Regulatory Ltd

Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance.

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Real Regulatory Ltd

Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance.

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