N-Glycan Analysis

N-Glycan and Glycopeptide Analysis

Have confidence in the consistency of your biotherapeutics manufacturing with glycosylation, including N-glycan analysis, from Prolytix. Our expertise includes tailored methods for neutral and highly sialylated glycans, mass spectrometry detection for glycan identity, and fluorescence detection for routine use.

Glycosylation, a common post-translational modification (PTM), plays an important role in recombinant protein bioactivity and pharmacokinetics (PK). Glycosylation is also an indicator of manufacturing consistency. We provide glycopeptide map as well as released N-glycan profiling data to give you the information you need for consistent, quality development.

N-Glycan Analysis Use Cases

  • Glycopeptide mapping
    • We can characterize glycans early in product development — as early as the cell line selection stage — to help clients pick a clone that produces product with the desired glycosylation profile.
    • We can analyze process intermediate samples to ensure that fraction pooling maximized the yield of a high-quality product, which is especially important when glycosylation is critical to potency or PK properties.
  • Released N-glycan profiling: We use released N-glycan profiling with fluorescence and/or HRMS detection to look at the consistency of N-glycosylation in purified proteins.

Advanced Analytical Techniques

Prolytix uses liquid chromatography (LC) with tandem high-resolution mass spectrometry (HRMS) and fluorescence detection to analyze some of the most complex glycoproteins found in nature. Our experience includes characterization of products from cell culture, plasma, and milk.