PEGylated Drug Bioanalysis

GLP PEGylated drug bioanalysis studies for PEGylated proteins or small molecules through both NMR and LC-MSMS bioanalytical approaches

PEGylation, or the addition of a polyethylene glycol (PEG) polymeric group to an active pharmaceutical ingredient (API), either a small molecule pharmaceutical or a biologic, can help the drug to stay in the body for much longer time periods. Because PEGylation greatly increases the molecular size of the drug molecule, they can be very difficult to analyze by standard techniques at the low concentrations such as those observed in biological samples like plasma or serum. Intertek can offer direct bioanalytical approaches that are either Good Clinical Practice (GCP) or Good Laboratory Practice (GLP) compliant with minimal sample preparation.

PEGylated Small Molecule Bioanalysis 

  • Liquid chromatography-atmospheric pressure ionization/tandem mass spectrometry (LC-API/MS/MS) detection of PEGylated small molecules
  • Quantification of PEGylated drugs in biological matrices by Nuclear Magnetic Resonance Spectroscopy (NMR)

PEGylated Large Molecule Bioanalysis 

  • Immunogenicity assays against the intact PEGylated protein or against individual fragments
  • Pharmacokinetic (PK) assays for PEGylated proteins to determine the concentration of the PEGylated drug product by using a bridging / sandwich ELISA assay platform.
  • Quantification of PEGylated proteins in biological matrices by nuclear magnetic resonance spectroscopy (NMR) 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

+1 800 967 5352
EMEA UK:
+44 161 721 5247