Biopharmaceuticals and glycosylation

Glycosylation is a major attribute of biotherapeutic products. From monoclonal antibodies and Fc-fusion proteins to cytokines and clotting factors, glycosylation patterns play a critical role in the efficiency and safety of these therapeutic molecules. For this reason, monitoring the glycosylation profile during the product development and manufacturing processes is of extreme importance.

Proteins that recognise and bind specific glycan structures, such as lectins, can be very useful in the analysis of glycosylated molecules. Most of the currently available lectins in the market are plant-based. However, GlycoSeLect’s Recombinant Prokaryotic Lectins, or RPLs, are much more specific, consistent and scalable than their counterparts, facilitating simple and effective analysis and isolation of intact glycoproteins.

A novel method for the analysis of glycosylated biotherapeutics

In a recent project, the Centre for Process Innovation (CPI) assessed the suitability of GlycoSeLect’s RPLs as a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. For this purpose, CPI integrated our RPLs into ForteBio’s biosensor platform and analysed the robustness of the quantitation assay for two biotherapeutics provided by Allergan Biologics, FSH (follicle stimulating hormone) and Eylea (Fc fusion protein). The samples were tested for terminal β1-4 galactose and sialic acid structures using RPL-Gal1 and RPL-Sia1, respectively. The linearity, repeatability and percentage spike recovery of each assay was verified.

Results demonstrated high intra-assay repeatability and linearity for the supplied FSH and Eylea samples. Furthermore, the percentage spike recoveries of 80-120% indicated that glycan detection is not compromised by the presence of the sample buffer.

Detailed results can be found in CPI’s poster.

This project consortium brought together the expertise and resources of CPI, GlycoSeLect UK Ltd, ForteBio Pall Life Science and Allergan Biologics Ltd, to address the need for new glycoanalytical approaches to meet the needs of the growing biotherapeutics market.