Analytical Development and Validation
Analytical Capabilities
- HPLC – SEC, IEX/Charge Variant, HIC, RP – Agilent 1000 series
- UHPLC – Agilent Infinity II 1290
- Microfluidic and gel electrophoresis – SDS-PAGE, Western blot, Microchip, IEF – Agilent 2100 Bioanalyzer, Invitrogen I-Blot, Bio-Rad ChemiDoc MP
- Colorimetric (UV/VIS), Fluorescence & Chemiluminescence activity assays –plater readers and automated analysers
- Nucleases (nicking and fluorescence based)
- Proteases (electrophoresis and fluorescence based)
- Endotoxin- LAL (Kinetic-QCL), USP/EP
- Bioburden- USP/EP
- Sterility – USP/EP
- Host cell protein – ELISA and Mass Spec (third party)
- Host cell DNA (Picogreen and qPCR) – Applied Biosystems 7500 Fast
- Peptide mapping (third party)
- Osmolality, pH and conductivity
- Electron microscopy
- Plaque assays
Stability Studies
- Accelerated
- Real time
Analytical Capabilities
- HPLC – SEC, IEX/Charge Variant, HIC, RP – Agilent 1000 series
- UHPLC – Agilent Infinity II 1290
- Microfluidic and gel electrophoresis – SDS-PAGE, Western blot, Microchip, IEF – Agilent 2100 Bioanalyzer, Invitrogen I-Blot, Bio-Rad ChemiDoc MP
- Colorimetric (UV/VIS), Fluorescence & Chemiluminescence activity assays –plater readers and automated analysers
- Nucleases (nicking and fluorescence based)
- Proteases (electrophoresis and fluorescence based)
- Endotoxin- LAL (Kinetic-QCL), USP/EP
- Bioburden- USP/EP
- Sterility – USP/EP
- Host cell protein – ELISA and Mass Spec (third party)
- Host cell DNA (Picogreen and qPCR) – Applied Biosystems 7500 Fast
- Peptide mapping (third party)
- Osmolality, pH and conductivity
- Electron microscopy
- Plaque assays
Stability Studies
- Accelerated
- Real time