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Multi-Site N-glycan mapping study 1: Capillary electrophoresis - laser induced fluorescence
Ákos Szekrényes1, SungAe Suhr Park2, Marcia Santos3
1a Horváth Laboratory of Bioseparation Sciences; University of Debrecen ; Debrecen , H-4032 , Hungary.
Mabs
|October 16, 2015
Summary
This study shows high reproducibility in N-glycan analysis using capillary electrophoresis with laser induced fluorescence detection. This method is reliable for biopharmaceutical applications like process development and lot release.
Area of Science:
- Biopharmaceutical Analysis
- Glycomics
- Analytical Chemistry
Background:
- N-glycans are crucial for biopharmaceutical protein function and efficacy.
- Standardized analytical methods are needed for reliable N-glycan characterization in drug development.
Purpose of the Study:
- To evaluate the reproducibility of N-glycan sample preparation and analysis.
- To assess the suitability of capillary electrophoresis with laser induced fluorescence detection (CE-LIF) for standardized N-glycan analysis.
Main Methods:
- An international collaborative study involving 20 laboratories.
- Analysis of 8-aminopyrene-1,3,6-trisulfonic acid (APTS)-labeled N-glycans using CE-LIF.
- Standardized reagents, samples, and equipment were used across all sites.
Main Results:
- Demonstrated low variability in migration time and peak area measurements.
- Achieved high reproducibility within and across participating laboratories.
- Confirmed the reliability of the CE-LIF method for N-glycan analysis.
Conclusions:
- The CE-LIF method for N-glycan analysis is highly reproducible and suitable for broad industry use.
- This standardized platform can support critical biopharmaceutical processes such as clone selection, process development, and lot release.
