St. Louis, Missouri Site

Specialized Capabilities

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

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.

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