Production
The Pfēnex process development and manufacturing facility contains significant pilot and production scale capacity including:
- Sixteen 20 liter fermentors
- Two 75 liter fermentors
- Two 1500 liter fermentors
- All fermentors are computer-controlled by a single network
- All vessels are equipped with exhaust gas monitoring to determine OUR, CER and Rq
- Automated resin screening at the 96-well scale for rapid identification of suitable chromatography resins
- Several AKTA units for optimization of purification
- Multiple skid-scale chromatography units capable of providing >200 grams of purified protein in a single operation
- Seamless transfer of production process to cGMP manufacturing
- 96 5 ml volume fermentors
- 16 1 L volume fermentors
Analytical
Pfēnex maintains a state of the art analytical capability in-house including:
Separations
- HTP Microchip-SDS-CGE
- HPLC and 2D-HPLC
- Capillary Electrophoresis
- Gas Chromatography
- Ion Chromatography
Mass Spectrometry
- MALDI-TOF
- Q-TOFmicro LC/MS
- Ion Trap LC/MS
- GC/MS
Spectroscopy
- Fluorescence
- UV-Vis/diode Array
- Evaporative Light Scattering
- Multiangle Laser Light Scattering
- Dynamic Light Scattering
- Luminescence
Immunochemistry
- HTP Biolayer Interferometry
- ELISA
- Western Blot
- Immunoprecipitation MS
- Kinetic Analyisis
Automation
- Automated sample preparation platform and analysis
- Liquid handling robots
- Customized methods
Impurity Analysis
- Q-PCR for host DNA
- HCP-ELISA
- Endotoxin
- Residuals
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