GEN-MKT-18-7897-A
Jun 19, 2017 | Biopharma, Blogs | 0 comments
Get to know how CESI-MS will allow you to quickly and accurately characterize protein therapeutics for attributes in a single method by downloading this discovery kit.The Biologics Characterization and Discovery Kit Includes:
A Unified Workflow for Monoclonal Antibody Charge Heterogeneity Purity, and Molecular Weight AnalysesDiscover how combining the unique separation capabilities of capillary zone electrophoresis (CZE) with the advantages of an MS-based detector provide high-resolution structural information and accurate molecular weight information. Using CESI-MS and stand-alone CE functionality of the CESI 8000 Plus system, researchers demonstrate powerful methods to characterize intact and reduced IgG forms.
CESI-MS Comparison of Tryptic Digests from Different Monoclonal Antibodies in an Assessment of BiosimilarityIncludes a summary of work recently published by the research group LSMIS at the University of Strasbourg. It focuses on how CESI-MS can be used to characterize and compare a marketed reference mAb with other biosimilar candidates. A CESI-MS protocol for biosimilarity studies of mAbs has been developed which highlights 100% amino acid sequence coverage & PTM “hot spot” mapping and ID.
Structural Characterization of Antibody-Drug Conjugates (ADCs) by a Combination of Intact, Middle-up and Bottom-up Approaches using CESI-MSThis tech note also summarizes work recently published by the research group at LSMIS. In this tech note, discover how CESI-MS can be used to characterize a gold standard cysteine-linked ADC, brentuximab vedotin. Want to learn more about highlighting DAR calculation under native conditions; drug distribution, drug location, 100% coverage and PTMs? It’s all here.
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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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