When it comes to biopharmaceutical characterization, you need a partner with established expertise and resources. As a pioneer of physicochemical characterization, we offer you unrivaled expertise in protein analysis. Our laboratories helped to develop mass spectrometry (MS) mapping of biotechnology products, together with other mass spectrometry strategies related to protein/glycoprotein analysis, which have become standards worldwide.
Our protein analysis package encompasses the requirements of the ICH guidelines (particularly ICH Q6B), the U.S. FDA 'Points to Consider' documents and the concept of a 'well characterized' or 'specified' biological product.
Individual analyses, or the full protein analysis package, are available to GMP and GLP, including:
- Amino acid sequencing
- N-terminal sequencing
- Peptide mapping by MS
- Glycosylation analysis
- Extinction coefficient
- Spectroscopic profiles: CD, FTIR, fluorescence
- Aggregation analysis: SEC-MALS, SV-AUC, DLS, SEC-UV
- Amino acid analysis
- C-terminal sequencing
- S-S Bridge analysis
- Molecular weight information
- Electrophoretic profiles
- Post-translational modifications
- Liquid chromatography:
- SEC, RP and IEX
To discuss your biopharmaceutical characterization requirements, contact us today.