Analysis and characterization of glycoproteins
Do you want to analyze and characterize your glycoproteins, understanding their detailed properties is essential?
Why perform a glycoprotein analysis ?
Analysis and characterization of glycoproteins in a lab are crucial for evaluating critical quality attributes (CQAs) such as primary structure, post-translational modifications, and biological activity. The effectiveness and immunogenicity of glycoproteins depend on these factors.
Rigorous control of these aspects is necessary throughout the development and manufacturing processes, following regulatory 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 analyzing and characterizing your glycoproteins
Why choose FILAB ?
FILAB, a laboratory specializing in analytical expertise, offers comprehensive analysis and characterization of glycoproteins in compliance with current guideline, including ICH Q6B.
Our expertise allows us to design analyses tailored to your specific needs at each stage of development, whether in preclinical characterization or in research and development.
Our analytical services can be customized to meet your requirements throughout the development and production cycle, with a particular focus on the critical quality attributes (CQAs) of your glycoproteins. FILAB provides a complete range of services for the characterization and analysis of glycoproteins.
Our glycoprotein analysis services
Structural analysis and characterization of glycoproteins :
Reduced Forms (HC, LC, Fab, FC)
Glycosylation Profiling
De Novo Sequencing
Physicochemical properties characterization :
We provide precise data on the size, mass, and physicochemical properties of your glycoproteins, which are essential for their development, validation, and quality control:
Impurity identification:
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 quantification of elemental impurities according to USP 233 and ICH Q3D, as well as analyses of extractables and leachables (E&L). We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of bioproduction processes.
FILAB provides tailored analytical solutions that cover all stages of glycoprotein development and production, ensuring high-quality results and regulatory compliance.
