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
  • 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.