As a biopharmaceutical manufacturer, you want to carry out a glycosylation analysis
What is glycosylation?
Glycosylation is an essential biological process in which chains of sugars (glycans) are attached to proteins or lipids. This post-translational modification (PTM) plays a key role in the structure, stability, and function of biomolecules. It is particularly critical in the biopharmaceutical field biopharmaceutical, where it influences the efficacy and immunogenicity of biomedicines, including monoclonal antibodies (mAbs) and therapeutic proteins.
Why perform a glycosylation analysis?
Glycosylation analysis is essential to ensure the quality and performance of biopharmaceuticals. It makes it possible to verify compliance with international regulatory requirements such as those of EMA, FDA and ICH. The analysis also helps assess the stability of biomolecules throughout development and production, thereby ensuring optimal performance.
In bioproduction, identifying and controlling glycosylation profiles makes it possible to optimize manufacturing processes and improve the yield of biopharmaceutical production. Finally, this analysis can detect structural variations that could affect the therapeutic efficacy and safety of products administered to patients.
FILAB supports biopharmaceutical manufacturers with glycosylation analysis
Why choose FILAB for glycosylation analysis?
FILAB, an analytical expertise laboratory, offers comprehensive services for glycosylation analysis. We provide a range of customized methods to assess the properties of proteins or lipids, tailored to each client’s specific needs.
Our glycosylation analysis services
Glycan structure analysis
Extraction and purification of glycans
Separation and identification of glycans
Glycan profiling
Glycan characterization
Quantification of glycosylated structures
Capillary electrophoresis separation
Protein glycosylation analysis
Determination of glycosylation sites
Comparison of production batches
Study of glycoform heterogeneity
Our biopharmaceutical services
Residual DNA
Impurity analysis: HCP (Host Cell Protein), ICH Q3D and USP 233 (elemental impurities)
Solvent and cell culture residues
Protein analysis: BCA method, Lowry method, CBQCA method, Bradford method
