Comprehensive biopharmaceutical product analysis and potency laboratory services addressing the challenges of identity, purity, safety and quality for proteins, monoclonal antibodies (mAb), vaccines, oligonucleotides and biosimilars.
Biopharmaceuticals (such as recombinant proteins, monoclonal antibodies, vaccines, peptides, oligonucleotides, biosimilars) can present unique analytical challenges during their development and manufacture. Intertek provides extensive GLP and cGMP biopharmaceutical services for biologics from early discovery through to GMP manufacture and beyond.
Intertek have over 20 years expertise in protein analysis and provide comprehensive services in line with the requirements of ICH Q6B guidelines including structural characterization, physico-chemical property analysis, impurity profiling and cell based bioassays. Intertek has expertise in advanced and comprehensive characterization studies, method development and validation (employing a diverse range of specialized techniques), ICH stability studies QC testing, GMP batch release analysis and more.
Protein Analysis Services (ICH Q6B)
- Protein Analysis
- Higher Order Structural Characterization
- Comparability Studies for Biopharmaceuticals
- Biologics and Biosimilar Product Release Testing
- Post-Translational Modifications
- Glycosylation Studies
- Biopharmaceutical Product Related Impurities Analysis
- Process Residuals Analysis
- Isolation and Characterization of Product-Related Impurities
- Biosimilars Testing Services
- Development and Validation of Specialist Methods
- Stability Studies for Biopharmaceuticals
- Total Protein Quantification
- Antibody Therapeutics Services
- cGMP Cell-based Bioassays
- Aggregation State Characterization
- Dynamic Light Scattering
Vaccine Analysis Services
Oligomedicine Analysis Services
Related Biopharmaceutical Services
Request more information to see how Intertek can help your organization with Biopharmaceutical Analysis.