Antibody Therapeutics Services
We provide comprehensive services for characterizing antibody therapeutics to provide details of both protein structure and glycosylation, which have been shown to have an important influence on biological activity.
The complex nature of therapeutic antibody products can present a number of unique challenges during their development and manufacture. Intertek offers a customized and strategic approach to characterizing antibody products using GLP or GMP compliant techniques validated to satisfy the latest regulatory documents and guidances (ICH Q6B).
Protein Characterization
Intertek offers characterization of glycoprotein structure and physicochemical properties employing state-of-the-art mass spectrometry, chromatography and electrophoresis instrumentation.
Specific Antibody Characterization Services
- Antibody typing and purity of intact antibody by 1D Gel Electrophoresis
- Isolation and purification of Fab/Fc fragments by Gel Electrophoresis or liquid chromatography
- Characterisation of purified Fab/Fc fragments
- Identification of glycopeptides following digestion and analysis by MALDI or LCMS
- Sialylation analysis by ion chromatography and normal or reverse phase chromatography
- N- and O-glycan characterization by MALDI or Ion chromatography
- Characterisation of deglycosylated protein by MALDI or ESI
- Process related impurity analysis
- Aggregation studies and comparability studies
Stability Studies
- Short-term, long-term, and forced degradation
Batch Release Testing
Intertek routinely provides analytical support services for batch release testing typically performed by biomanufacturing facilities to ensure consistency in material purity, identity and activity. Intertek's antibody therapeutics laboratory also offers expertise for monoclonal antibodies (mAbs), polyclonal antibodies and antibody drug conjugates.
Related Services
Request more information to see how Intertek can help your organization with Antibody Therapeutics Services.