GEN-MKT-18-7897-A
Jun 5, 2018 | Biopharma, Blogs | 0 comments
Why LC-MS MAM?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.
Why SCIEX?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 LineThe 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 >
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
At SCIEX, innovation doesn’t stop at instruments; it extends to how you interact with your LC-MS/MS or CE systems every day. That’s why we’re excited to introduce the SCIEX Now spring 2026 improvements: a set of meaningful enhancements shaped directly by your feedback.
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