TIDES: Oligonucleotide and Peptide Therapeutics Digital Week is part of the Informa Connect Division of Informa PLC

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Intertek

Profile

Our capabilities include GLP bioanalysis and GLP or cGMP characterization for oligonucleotide therapeutics. We support product development from QC testing of amidite starting materials and early stage product characterization through to GMP batch release testing. We provide cell-based potency testing, physicochemical properties, identity, structure, internucleoside and sequence determination, purity and identification of (product-related and process) impurities, through application of a combination of mass spec, chromatographic and /or spectroscopic methods. These include purity and impurity profiles by UPLC, HPLC, LC-MS, IEX-HPLC, CGE, NMR, detailed MS characterisation using MALDI MS, ESI-MS, CMS, LC-MSMS and 31P-NMR characterisation of APIs and product related P containing impurities. We also perform higher order and aggregation studies. We are adept at method development and validation and apply these methods can be applied to GMP compliant QC, stability and release testing. Our GLP laboratories typically apply a range of bioanalytical techniques including ELISA, mass spectrometry approaches (LC-MS/MS, and UPLC-MS/MS) and capillary gel electrophoresis (CGE).