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
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