Quality Control and Analytical Testing Capabilities
Release and stability testing: drug substance, drug product, sterile diluent
Biologic and chemical assays: drug product, API, raw materials
- High-performance liquid chromatography (HPLC), including size exclusion (SEC)
- Reverse phase purity/impurity methods
- Peptide mapping
- UV/VIS spectroscopy
- Karl Fischer moisture content
- SDS-PAGE and densitometry
- Imaged capillary electrophoresis (iCE)
- Capillary gel electrophoresis (CGE)
- Microplate- and cuvette-based enzyme activity assays
- ELISA
- NIR and FTIR
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Wide range of wet chemistry analysis including pH, conductivity, titrations, osmometry
Microbiology
- Total organic carbon (TOC) analysis using Sievers M9, endotoxin
- Kinetic chromogenic (water and in-process)
- Bioburden via membrane filtration (water and in-process)
- Conductivity
- Microbial identification
- Cell line characterization
- Microbial testing of upstream processes (culture purity, hemolytic testing)
Want to learn more? Get in touch!
Pearse Kelly, 484-216-2812, kelly.pearse@endo.com