St. Louis, Missouri
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.
Specialized Capabilities include:
Analytical Laboratory Capabilities include:
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
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.