Our capabilities include GLP bioanalysis and GLP or cGMP characterization for oligonucleotide, mRNA, all classes of protein and peptide-based therapeutics and vaccines. We support product development from QC testing of 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 the application of a combination of mass spec, chromatographic and /or spectroscopic methods.
For oligos and mRNA products in particular, our capabilities include purity and impurity profiles by UPLC, HPLC, LC-MS, IEX-HPLC, CGE, NMR, detailed MS characterisation using MALDI MS, ESI-MS, LC-MSMS and 31P-NMR characterisation of APIs and product-related P containing impurities. We provide specialist mRNA testing including integrity, Poly A tail, and capping efficiency. 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).