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. Their structural characteristics must be well understood to ensure product's quality and identity. Any process or product related impurities must be identified and quantified and biophysical properties and biosafety must all be explored to ensure a safe biologic medicine.
Intertek provides extensive GLP and cGMP biopharmaceutical services for biologics from early stage through to GMP manufacture and beyond. With over 20 years experience in the analysis of protein products or oligonucleotides Intertek's comprehensive services have been developed with the relevant regulatory guidance in mind. For protein products in particular, services in line with the requirements of ICH Q6B guidelines including structural characterization, physico-chemical property analysis, impurity profiling and cell based bioassays offer a one-source solution for our clients, supporting their product development from early stage through to manufacturing. Intertek has expertise in advanced and comprehensive characterization studies, method development and validation (employing a diverse range of specialized techniques), 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.