Analysis and characterization of glycoproteins
Do you want to characterize your glycoproteins and understand their detailed properties? It is essential.
Why carry out a glycoprotein analysis?
Glycoprotein analysis, or glycoprotein characterization in the laboratory, is important for assessing critical quality attributes (CQAs), such as primary structure, post-translational modifications, and biological activity.
The efficacy and immunogenicity of glycoproteins depend on these factors. Rigorous control of these aspects is necessary throughout development and manufacturing processes, following guidelines such as ICH Q6B.
It is important to understand the variations that can impact CQAs, such as glycosylation profiles, charge variants, size variants (aggregates), and different fragments. All of this aims to assess the heterogeneity of the biotherapeutic.
Our solutions for the analysis and characterization of your glycoproteins
Why choose FILAB?
FILAB, a laboratory specializing in analytical expertise, offers in-depth analysis and characterization of glycoproteins, in compliance with current guidelines, notably ICH Q6B. Our expertise enables us to design analysis tailored to your specific needs at every stage of development, whether for characterization in the preclinical phase or in research and development.
Our analytical services can be customized to meet your requirements throughout the development and production cycle, with particular attention paid to the critical quality attributes (CQAs) of your glycoproteins. FILAB offers a full range of services for glycoprotein characterization and analysis.
Our glycoprotein analysis services
Structural analysis and characterization of glycoproteins:
Cartographie de peptide / peptide mapping
Formes réduites (HC, LC, Fab, FC)
Characterization of physicochemical properties:
We provide precise data on the size, mass, and physicochemical properties of your glycoproteins, which are essential for their development, validation, and quality control:
Molecular weight and size (intact mass by LC-MS and SEC-Triple Detection)
Thermal stability (DSC)
Spectroscopic profiles (UV/visible absorption, FTIR)
Chromatographic profile (charge variants by IEX-UV – Ion Exchange Chromatography)
Extinction coefficient (UV absorption)
Concentration and purity control by NanoDrop® spectrophotometry
Impurity identification
The detection, analysis, and characterization of impurities are crucial to ensure the safety, efficacy, and regulatory compliance of glycoproteins:
For process-related impurities, our laboratory offers specific tests, such as the quantification of elemental impurities according to USP 233 and ICH Q3D, as well as extractables and leachables (E&L) analysis. We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of bioproduction processes.
FILAB is dedicated to providing tailored analytical solutions covering all stages of glycoprotein development and production, ensuring high-quality results and regulatory compliance.
