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TheraProteins

Oligosaccharide Reference Standards 
for Quality Control Testing of recombinant glycoprotein pharmaceuticals

 

 
TheraProteins offers more than 250 different oligosaccharide (N-glycan) structures of highest purity. Our catalogue contains fully characterized and quantified reference N-linked oligosaccharide structures for use in:

-    Quality release testing of pharmaceutical glycoproteins (drug substance  and dosage forms) 
-    Lot-to-lot consistency,
-    Stability studies 
-    In product intermediate analysis
-    Primary structural analysis for regulatory file submissions

  • More than 70 oligosaccharides standards for recombinant biopharmaceutical glycoprotein profiling / mapping
    (quantitative Quality Release Testing  of sialylation profile, antennarity, Galß1-4GlcNAc repeat content and others )

  • More than 35 N-linked oligosaccharides for recombinant antibody profiling / mapping (Quality testing)

  • More than 150 different other oligosaccharides from CHO cells or other cells for N-glycosylation profiling / mapping (Quality testing), for NMR studies or for use as standards in mass spectrometry
  • More than  50  different oligosaccharide structures from natural glycoproteins


TheraProteins oligosaccharides are quantified and characterized using complementary methods e.g. validated HPAEC-PAD analysis, ESI-MS (or MALDI-MS). The basic structures are analyzed by NMR spectroscopy.


 

Services

  • Custom services
  • N-linked  oligosaccharide structure preparation (100µg – 20 mg quantities) 
  • Including full characterization and quantification of the products 
  • Glycosylation analysis of total cell glycoprotein 
  • Analytical service in glycoprotein characterization total cell glycosylation analysis of recombinant cell lines and primary cells 
  • Supply of glycopeptides with defined N-glycans in 0.1-10 mg quantities 
  • Glycoprotein primary structural analysis for research purposes