GEN-MKT-18-7897-A
Aug 25, 2017 | Blogs, Technology | 0 comments
Stay ahead of the curve by using the most advanced and versatile high-resolution accurate mass technology. The TripleTOF® 6600 accurate mass QTOF system can help you to analyze your samples faster, without compromising between speed, resolution, and sensitivity. Explore the technological advances that give this system the performance edge.
In addition, you can get the flexibility your lab needs by configuring with nanoflow, microflow, conventional flow LC, or with capillary electrophoresis spray ionization (CESI) separation systems. And condensed data file sizes simplify and streamlines data storage and portability, without losses in data quality, completeness, or security.
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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