— Glycans are notoriously complex and hard to analyze—a problem that has long held back biopharmaceutical R&D. As regulators tighten their requirements, glycosylation analysis is making its way from the lab bench to the production line.
Glycosylation isn’t just a nice-to-have modification—it’s a make-or-break factor that determines the fate of therapeutic proteins in the body. Over 60% of FDA-approved biologic drugs are glycoproteins, and even minor differences in glycan structures can lead to significant variations in efficacy and safety. Regulators have long taken note of this, with the FDA and EMA explicitly requiring systematic glycosylation profiling in multiple guidance documents. For R&D scientists on the front lines, however, the structural complexity of glycans and the high barrier to analytical techniques remain a persistent and tangible challenge.
CD BioGlyco’s recently launched one-stop glycomic characterization service platform was created specifically to address this challenge. The workflow consists of four steps:
- N-glycans are released using PNGase F (following protein denaturation and reduction/alkylation);
- O-glycans are released via reductive β-elimination;
- Released glycans are separated using high-performance liquid chromatography;
- The separated glycans are then analyzed by MALDI-TOF MS and LC-MS/MS to determine molecular weight and monosaccharide composition; linkage types and branching patterns are further elucidated through complementary techniques such as exoglycosidase sequencing and methylation analysis.
Following analysis, experimental methods, raw data, and analytical conclusions are compiled into a single, comprehensive report delivered to the client.
As for sample types and sensitivity—serum, cell lysates, tissue extracts, and biopharmaceutical intermediates can all be processed. The technical team noted that for routine samples, N-glycan profiling requires only microgram-level amounts of protein. Since early-stage R&D projects often deal with precious and limited samples, this sensitivity provides a tangible advantage.
The platform’s real-world value has already been demonstrated across multiple fields. In cancer research, shifts in glycosylation patterns are closely tied to metastasis and drug resistance—and accurate readouts can help guide treatment decisions. Vaccine development follows the same principle: reliable glycan antigen data is essential before you can even begin designing an immunogen. Neurodegenerative disease research and functional food development also rely on glycan analysis to move forward.
The growing importance of glycomic characterization is reflected in recent scientific literature. A 2022 study published in the journal Molecules demonstrated an integrated analytical platform combining mass spectrometry with glycomics and glycoproteomics approaches to evaluate the glycosylation-inhibitory activity of pictilisib, a PI3K inhibitor repurposed as a glycosylation inhibitor candidate—highlighting the expanding role of MS-based glycomic analysis in inhibitor screening and drug development.
CD BioGlyco is based in Shirley, New York, and its analytical lab is equipped with multiple high-resolution mass spectrometry systems and chromatography instruments. Beyond glycomic characterization, the company also offers complementary services including glycoprotein analysis, glycan array screening, and glycoconjugate vaccine development.
References：
Alonso, M. R. S., Zhang, Q., et al. An Integrated Mass Spectrometry-Based Glycomics-Driven Glycoproteomics Analytical Platform to Functionally Characterize Glycosylation Inhibitors. Molecules. 2022;27(12):3834. doi:10.3390/molecules27123834.
Contact Info:
Name: Anna Bryan
Email: Send Email
Organization: CD BioGlyco
Website: https://www.bioglyco.com/
Release ID: 89200443
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