The Thermo Fisher Scientific St. Louis facility offers full mammalian cell process development including late stage characterization and process validation to support clinical (Phase I-III) to commercial manufacturing.
Analytical Laboratory Capabilities
- Chromatography: affinity, lEX, SEC, HIC, RP, peptide mapping
- MW determination by mass spectrometry
- Electrophoresis: SDS-PAGE densitometry & IEF
- Sequence confirmation and PTM/degradation by LC-MS/MS
- Potency: binding ELISA, enzymatic activity assays,cell-based potency assay
- Aggregates by SEC-MALS
- Impurity: residual Protein A, HCP, residual DNA
- Subvisible particles by LO
- Quantity: protein A/G HPLC, ELISA titer assay, A280
- Amino Acid Analysis by UPLC
- Capillary electrophoresis (CE-SDS, cIEF, CE-LIF)
- Extinction Coefficient determination
- DOE for method development and method validation
- N-Glycan profiling by fluorescence-labeling and normal phase HPLC or CE
- Protein conformation characterization using capillary DSC
- Sialic acid content and NANA/NAGA ratio measurement
- High throughput CE-SDS and glycan profiling with microfluidic instrument
- Monosaccharide Analysis
- Charged Aerosol Detector (CAD) used to test Polysorbate, Anti-foam, Pluronic
This site features a strong regulatory inspection history from all major regulatory agencies.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.