We are pleased to announce that glyXera, together with our research partners at the University of Salzburg, successfully published the cover article of the October issue of the Journal of Pharmaceutical Analysis with the title “‘Small is beautiful’ – examining reliable determination of low-abundant therapeutic antibody glycovariants”.
Glycosylation is a critical quality attribute (CQA) for recombinantly produced therapeutic glycoproteins like comparatively simple monoclonal antibodies (mAbs) or more complex biomolecular formats such as bi/multi-species antibodies, Fc-fusion proteins, Antibody–drug conjugates (ADCs), hormones, cytokines, etc., and is therefore monitored throughout drug research & development and during their approval, release & production stages to ensure product and process consistency.
The glycans associated with those biopharmaceuticals play crucial roles, e.g. in drug safety and efficacy, and therefore, their reliable detection, identification, and quantification is essential. This study introduces a multi-level approach for glycosylation analysis in monoclonal antibodies, focusing on minor abundant glycovariants.
The highly sensitive and highly resolved analysis of the released N-glycans with our glyXboxCE system forms the basis for integrating information across different structural levels, spanning glycans, glycopeptides, and up to intact glycoproteins.
Our workflow’s utility is demonstrated on NISTmAb, rituximab and adalimumab, profiling their minor abundant variants for the first time across all structural levels. This study enhances understanding and accessibility in glycosylation analysis, spotlighting minor abundant glycovariants in therapeutic antibodies.
The article is published open access and can be read in full on the publication web page: https://www.sciencedirect.com/science/article/pii/S2095177924000790
If you would like to learn more about our high-performance glycan analysis products, including glyXboxCE, or are interested in a research cooperation, please feel free to get in touch.