Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
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
PEGylated Large Molecule Bioanalysis
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