Join us at Well Characterized Biologics and Biological Assays 2019
During the Well Characterized Biologics and Biological Assays Conference 2019 (11-12 Nov, Reston,VA) connect with Intertek to explore how we can help you accelerate your biologic development programs.
This event brings together industry leaders sharing best practices for accelerating novel and complex modules towards CMC Success. Our technical expert , Michael Walker, will be presenting during the Analytical Characterization – Glycan and Glycosylation Analysis Methods session examining approaches in biologic characterization that give site specific relative levels of glycosylation. Visit Booth #11 in the exhibit hall to discuss how our expertise across biopharmaceutical development support can accelerate your program milestones or contact us now to arrange a meeting during the event.
WELL CHARACTERIZED BIOLOGICS AND BIOLOGICAL ASSAYS PRESENTATION:
Monitoring of Glycosylation using Site Specific Approaches
Tuesday 12th November, 2pm
Michael Walker, Technical Expert, Intertek Pharmaceutical Services
If you would like a copy of the presentation, please send a request now to receive the slides after the event.
Abstract: N-linked glycosylation is a common post-translational modification found on many antibody based biotherapeutics, and has been linked to safety, stability and activity of the drug substance. It is therefore important that the modification can be monitored and controlled as required. A commonly employed method for characterizing glycosylation utilizes enzymatic removal of the glycans followed by labelling with fluorescent groups. The labelled glycans are then separated by hydrophilic interaction chromatography (HILIC) and detected / quantified by detection of the fluorescent group. The glycan identity can be predicted based on the elution time and supporting mass spectral data. Although sensitive, as glycans are cleaved from the entire protein, site-based information is lost. Hence, if the biotherapeutic has more than one potential site of glycosylation, then any information on glycan sub populations linked to different sites is not ascertained. With the increasing numbers of bi-specifics in development the number of molecules with more than one site of glycosylation is increasing. Methods like peptide mapping and middle-up mass spectrometry can give site specific relative levels of glycosylation, through sub-division of the protein. Here we will discuss the use of these approaches to give relative levels of different glycoforms, at specific sites, and compare to the enzymatic stripping and fluorescent labelling approach. As well as being a powerful approach for monitoring glycosylation during product characterization, they are promising candidates for automation to provide rapid, high-throughput analytical screening to drive decision making during process development.
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At Intertek, our scientists offer characterisation expertise across multiple molecule classes, applying our experience, industry and regulatory knowledge to design phase specific analytical development programs, tailored to your needs throughout the product lifecycle. We focus on monitoring relevant critical quality attributes (CQAs), demonstration that process changes do not impact physicochemical properties and structure, determining the presence of product related impurities or process-related impurities. We also help you to demonstrate consistency or comparability of manufactured batches or as release tests for clinical trial materials or ongoing GMP batch release tests.