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:

• Process development for all mammalian cell lines
• In house analytical expertise, QC and QA
• Expertise in fed batch and perfusion processes
• In house and partnered cell line development – CHO (Chinese Hamster Ovary)
• Single use and flexible stainless steel technologies
• Upstream and downstream process development expertise

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.