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Product Quality Assessments of Biotherapeutics Using LC-MS MAM

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The Liquid Chromatography-Mass Spectrometry Multiple Attribute Methodology (LC-MS MAM) is a technique that is quickly gaining traction in the development and manufacturing of biopharmaceuticals. But what exactly is MAM? As researchers describe in a recent article entitled The Emergence of Multiple Attribute Methodology (MAM) Workflows by LC-MS for Accurate Biotherapeutic Product Quality Assessments in the November/December 2017 issue of Chromatography Today, the workflow is based on a technique called peptide mapping and has the ability to monitor many attributes of the biologic simultaneously. For example, the types and amounts of different modifications, levels of heterogeneity, and degree of impurities can all be combined within one analysis. Not only is this a huge time-saver, but it also simplifies the overall number of different analytical methods that need to be learned, monitored, and performed.

An LC-MS MAM workflow can increase productivity tremendously, and many laboratories are in the process of transitioning their assays to this new technique. But what makes the SCIEX LC-MS MAM workflow so powerful? As the authors discuss, it’s really the inclusion of several key features that make the SCIEX MAM technique so compelling. First, the SCIEX methodology uses a SWATH® Acquisition technique to fully characterize the reference biologic which has been shown to be more complete and reproducible than traditional acquisition methods currently in practice. Second, the software used for characterization, BioPharmaView™ Software, is the same software that is used for monitoring samples. With its intuitive user interface and streamlined workflow, learning and implementing the entire MAM procedure is straightforward. And third, with the SCIEX MAM technique, new peaks that may arise from any new contaminants entering the production process are detected. This is critical for addressing issues well before they have the potential to ruin an entire production batch.

The Bottom Line
The MAM workflow is an exciting new development for many biotherapeutic production labs, saving valuable time and streamlining the quality and manufacturing process. In particular, the SCIEX LC-MS MAM workflow provides several key features that significantly enhance productivity even further.Read the Chromatography Today Article >

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