Analysis and characterization of Monoclonal Antibodies (mAbs) in laboratory
You would like to carry out an analysis and characterization of your monoclonal antibodies (mAbs).
Analysis and characterization of monoclonal antibodies (mAbs) in a laboratory are essential for assessing critical quality attributes (CQAs) such as primary structure, post-translational modifications, and bioactivity. The efficacy and immunogenicity of mAbs depend on these factors.
Rigorous control of these aspects is necessary throughout development and manufacturing, following guidelines like ICH Q6B. It is important to understand the variations that can influence CQAs, such as glycosylation profiles, charge variants, size variants (aggregates), and different fragments, all with the aim of assessing the therapeutic heterogeneity.
Our solutions to meet your mAbs analysis and characterization
FILAB, an analytical expertise laboratory, provides in-depth expertise in the analysis and characterization of monoclonal antibodies (mAbs) in compliance with current guideline, particularly ICH Q6B.
This expertise enables us to design analyses to your specific needs at various stages of development, whether in preclinical characterization studies or research and development.
Our laboratory’s analytical services can be customized to meet your needs throughout the development and production cycle, with a particular focus on the critical quality attributes (CQAs) of your mAbs.
FILAB offers a comprehensive range of monoclonal Antibody (mAbs) characterization and analysis services
Structural analysis and characterization of mAbs:
Reduced Forms (HC, LC, Fab, FC)
Glycosylation Profiling
De novo Sequencing
Characterization of physicochemical properties
Our laboratory provides precise data on the size, mass, and physicochemical properties of mAbs, which are essential for their development, validation, and quality control.
Identification of impurities in biopharmaceutical products
Other impurities (compliance with ICH Q3D, E&L, etc.)
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) analyses. We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of bioproduction process.
