GEN-MKT-18-7897-A
Jul 7, 2016 | Biopharma, Blogs | 0 comments
Today, 30 monoclonal antibodies (mAbs), have been approved for the treatment of certain cancers, autoimmune and infectious diseases. Even more are in development, and perhaps you and your team of scientists are working on one now. Keeping pace with fast development timelines while performing comprehensive characterization of biologic candidates can be challenging. However, more and more, scientists are tackling these challenges with new techniques to speed and simplify their characterization workflows. Read more in the application note, “Rapid Characterization of Biologics using a CESI 8000 – SCIEX TripleTOF® System,” found in the Biologics Analytical Characterization Compendium, which highlights how CESI separation coupled with high-resolution mass spectrometry can provide a comprehensive characterization of biotherapeutics.
Download the Compendium to learn more >
OverviewCapillary electrophoresis (CE) integrated with electrospray ionization (ESI) creates a single dynamic process, called CESI. CESI coupled with the Information Dependent Acquisition (IDA) mode of a TripleTOF® 5600+ or 6600 systems can enable you to:
Make the shift to better biological characterization. Get to know the detailed analysis of experiments like this and much more including intact mass analysis, purity and heterogeneity determination, glycan analysis, biosimilar comparability, and host cell protein detection. With better information, you can make better decisions. Let the Biologics Characterization Compendium help guide you.
See the results in the full article, pages 56-65, by downloading the Biologics Analytical Characterization Compendium.
Finding the right information shouldn’t slow you down. Whether you’re troubleshooting your mass spec, learning something new, or optimizing performance, access to the right resources at the right moment makes all the difference.
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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