Structural analyses
Measures the secondary, tertiary, and quaternarystructure of biologically active proteins
- Fourier Transformed Infrared Spectroscopy (FTIR)
- Fluorescence Spectroscopy
- Differential Scanning Calorimetry (DSC)
UPLC/HPLC methods
Monitors various degradation of protein therapeutics
- Size-exclusion
- Ion-exchange (cation-exchange, anion-exchange)
- Reversed phase
- Hydrophobic interaction
- Various detectors: UV, fluorescence, reflective Index, evaporative light scattering
Electrophoresis
Separates impurities based on both charge and mass
- Capillary Electrophoresis (CE)
- Sodium dodecyl sulfate electrophoresis (SDS-PAGE)
Particle analysis
Identification and quantification of particulates
- Flow imaging microscopy (MFI and Flowcam): excellent for sub-visible particles
- Dynamic light scattering (Zetasizer, Wyatt)
- HIAC Liquid Particle Counter
Viscosity
Measurement for manufacturing process as well as injection through narrow bore needles
Other useful analytical methods
- Subambient differential scanning calorimetry (characterization of frozen formulations)
- Imaged capillary isoelectric focusing (icIEF)
- Karl Fisher moisture titrator
- Osmometry, SoloVPE