ANALYTICAL METHODS

IDRI provides analytical development and quality control services to support formulation development, manufacturing, product release and stability studies. Existing analytical methods can be applied for quantification, characterization and identification of product. New methods may be developed and qualified, and existing compendia methods are verified as needed.

BIOCHEMISTRY
  • Protein content (UV & BCA)
  • Electrophoresis (SDS-PAGE, Colloidal blue, Silver stain, Western, IEF)
  • Immunogenicity (ELISAs)
CHROMATOGRAPHY
  • Gas chromatography for squalene quantitation and residual solvents
  • HPLC quantitation or characterization for Lipid A, Phospholipids and Oligonucleotides
PHYSICO-CHEMICAL
  • Appearance
  • pH
  • Osmolality
  • Particle size
  • Conductivity
  • Growth promotion and media sterility
  • Residual moisture
OUTSOURCED METHODS
  • Sterility
  • Bioburden
  • Endotoxin
  • Pyrogenicilty