Assess Your Biologic’s Stability with Purity Testing
Gain lasting confidence in your drug’s composition with identity testing in the form of separation and quantitation – a trusted purity test backed by chromatographic, electrophoretic, and spectroscopic instrumentation. These analytical characterization assessments are valuable for contributing to a larger formulation or process endeavor and acting as a limited troubleshooting tool or feasibility study.
When your project is ready to execute your next purity test, our team of expert researchers are ready to implement identity testing for your biologic.
Chromatographic Methods
LC Separation
- RP, SEC, IP-RP, HIC, HILIC, IEX, Mixed Mode
- AF4 – Shear Sensitive or Large Complexes
LC Detection
- UV, FLR, ELSD, CAD, RI, MALS
- MS (QQQ and HR)
Capillary Electrophoresis
- cIEF and icIEF
- Reducing and Non-Reducing CE-SDS
Mass Spectrometry
- Intact Top-Down, Middle-Down Mass Analysis
- Peptide Mapping
- Chemical and Post-Translational Modifications
- Disulfide Bond Mapping
- Glycosylation (N- and O-linked)
- Carbohydrate Analysis (Released Glycans, Monosaccharides, Sialic Acid)
- Identification of Process Impurities and Related Substances
- HCP Identification
- Bioanalytical Quantitation
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.