Method Development Services

CATEGORY: TECHNIQUE/EQUIPMENT: OBJECTIVE

• Physico-chemical:
  Capillary isoelectric focusing (cIEF): separation of protein variants
• Microfluidic electrophoresis: automated protein sizing and relative quantitation
• HPLC-RP/IEX with PDA/CAD/Fluo: High Performance Liquid Chromatography with Reverse Phase/Ion-Exchange/Size-Exclusion with Photo Diode array or Charge Aerosol or Fluorescence detection: Content or purity determination of proteins or small molecules
• UPLC-PDA-MS/MS: Ultra Performance Liquid Chromatography with Photo Diode Array or Tandem Mass Spectroscopy detection: Multi-analyte determination
• LAL Endotoxin: Limulus amebocyte lysate assay: Quantification of residual LPS or endotoxin
• Colorimetry (optical density, absorbance and transmission) cuvette and multiwell plate.: Optical quantification, BCA, Lowry etc.
• SDS-PAGE: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis: Size separation and purity determination
• Biophysical:
• SEC-MALLS: Size-exclusion Chromatography with Multi-Angle Laser Light Scattering: Direct molar mass and size distribution
• SEC-FLUO/UV: Fluorescence or ultraviolet-detection Size-exclusion Chromatography: Aggregation determination
• DLS: Dynamic Light scattering: Particle size and size distribution determination
• Nephelometry: Detection of insoluable particles
• Immunological:
• Western Blot: Size separation and antigen specificity characterization
• ELISA: Enzyme-Linked Immunosorbent Assay: Antigenic activity and identification
• qPCR: Quantification of target or residual DNA
• SRID: Single Radial Immunodiffusion: Hemagglutinin potency assay
• General:
• Osmolality: Aqueous/freeze dried solutions:  Enumeration of moisture content
• pH: Aqueous solutions:  Levels of acidity or alkalinity determined
• Turbidity: Measurement of relative clarity of a liquid against guidelines or specifications
• Viscosity (Brookfield method): Viscosity, or , flow resistance of liquid in stated conditions
• Photostability: Simulated prolonged light exposure stability studies
• Visual Inspection (EP and USP): Observation according to noted standards
• Cell-based assays: Potency of target molecules