GEN-MKT-18-7897-A
Mar 17, 2017 | Biopharma, Blogs | 0 comments
There is a lot of talk going around in the lab, and it has to do with the newly released Fast Glycan Labeling and Analysis technology. Where once research analysts needed to set aside days to perform glycan analysis, now takes an hour or so. Glycans are immediately identified by the software – so no need for data interpretation. That’s up to 5x faster than HILIC.
Short and simple 60-minute sample prep, followed by a 5-minute high-resolution separation provide immediate glycan identification and quantitation. Since glycan identification is automated, the Fast Glycan technology also eliminates the need for manual database searches while removing the potential for human error from the process.
Bioprocess International recognized our Fast Glycan technology and awarded it the 2016 Best Technology Application – Analytical Award.
Based on magnetic bead technology, it does not require centrifugation or advanced pipetting techniques, making the assay suitable for manual pipetting as well as automation. Researchers can, therefore, quickly detect changes in glycosylation, helping profile glycans that may effect changes in function, efficacy, and clearance of their biologics.
What does this mean for your lab, and how can you test the process yourself? To help you better understand the process, researchers documented the Fast Glycan Labeling and Analysis technology for N-glycosylation analysis in the following application note, “High-Resolution Separation and Identification in Minutes.”
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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.
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