GEN-MKT-18-7897-A
Aug 14, 2018 | Blogs, Clinical | 0 comments
According to the American Clinical Laboratory Association, more than 7 billion clinical lab tests are performed in the U.S. every year. While mass spectrometry represents only a fraction of the clinical applications, there are a growing number of tests where mass spectrometry is becoming the analytical method of choice. This is particularly the case where accuracy is challenged by interference from other compounds, such as toxicology testing, therapeutic drug monitoring, and in the measurement of low-level endogenous steroids.
This trend shift is driven by the analytical specificity of mass spectrometry as well as the advancement of this technology along with the development of new applications. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a particularly powerful, accurate, and robust technique for clinical diagnostics, especially for quantitative analysis of low concentration compounds. When comparing to conventional analytical techniques, the unique capabilities of mass spectrometry makes it is easy to see why mass spectrometry adoption is accelerating and beginning to play a prominent role in more areas of medicine.
As more labs make the move to mass spec, we look at the top five reasons why:
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As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
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.
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