The complex nature of antibodies developed as therapeutics products can present numerous challenges during their development and manufacture. Such products must be well characterized allowing a detailed understanding of both the protein structure and glycosylation, that latter of which has been shown to have an important influence on biological activity.

Intertek offers tailored, strategic, approaches to characterize antibody products using GLP or GMP compliant techniques, adapted to each customer's needs and validated to satisfy the latest regulatory demands (ICH Q6B). The facility is fully accredited UK GLP Regulatory Compliance Program and has been audited to GMP by the MHRA and US FDA.

Key Services:

Protein characterization

Intertek Pharmaceutical Services offers glycoprotein characterization of structure and physicochemical properties employing state-of-the-art mass spectrometric, chromatographic and electrophoretic instrumentation.

Specific Antibody Characterization Services:

• Antibody typing
• 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
• Comparability studies

Stability Studies

A range of stability testing, including short- and long-term and forced degradation (pH, oxidizing, temperature, etc.) are available. Stability is tested at various temperatures and humidity.

Batch release testing

Intertek has significant experience in providing analytical support to supplement basic release testing typically performed within biomanufacturing facilities. Routine analysis of manufactured production lots is of critical importance to ensure consistency in material purity, identity and activity.

Applications:

• Polyclonal antibodies
• Monoclonal antibodies
• Antibody drug conjugates
• Antibodies for diagnostics