Biopharmaceutical Analysis
We offer comprehensive Biopharmaceutical GMP analysis and characterization services for proteins, vaccines and biologics.
Biopharmaceuticals (e.g. recombinant proteins, monoclonal antibodies, vaccines, synthetic peptides, oligonucleotides) can present unique analytical challenges during their development and manufacture.
Intertek provides extensive GLP and cGMP biopharmaceutical services for biologics, including advanced analytical R&D and complex characterization studies, method development and validation (employing a diverse range of specialized techniques), QC services for biopharmaceutical production and ICH stability studies.
Intertek have particular expertise in protein analysis and provide comprehensive services in line with the requirements of ICH Q6B guidelines.
Protein Analysis Services
- Protein Analysis
- Higher Order Structural Characterization
- Aggregation State Characterization
- Comparability Studies for Biopharmaceuticals
- Biologics and Biosimilar Product Release Testing
- 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
Vaccine Analysis Services
Oligomedicine Analysis Services
Related Biopharmaceutical Services
Request more information to see how Intertek can help your organization with Biopharmaceutical Analysis.