Want to know the glycosylations of your drug substance protein?
We offer determination of the number, position and type of glycosylations in your drug substance protein.
The ICH Q6B Guidelines (Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) requires determination of number, position and type of glycosylations.
Glycosylation of proteins is one of the most common post translation modifications in biopharmaceuticals. Glycoproteins contain complex sugar moieties whose presence, absence, sites of attachment, and relative abundance can have a major impact on the efficacy and stability of the drug substance.
Full glycosylation analysis includes three parts
Part 1: Determination of exact molecular weight
- Exact molecular weight of glycoprotein determined by UV-LC ESI-MS
- Exact molecular weight of deglycosylated protein determined by UV-LC ESI-MS
Part 2: Design and execution of glycopeptide mapping experiment
- Glycoprotein is digested with one of more proteases and analyzed by nano LC-MS/MS
- Searched against drug substance sequence with various combinations of glycostructures
Part 3: Analysis of individual glycopeptides from digest
- Individual glycopeptides are analyzed by UV-LC ESI-MS/MS
- Individual glycopeptides are isolated in a UV-HPLC run and subsequently analyzed by MALDI-MS/MS
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