In biological substances coming from preclinical and clinical studies, we have a long track record of developing and validating bioanalytical methods from scratch or working with transferred methods. Furthermore, we have a great capacity for processing samples. In order to quantify the plasma or serum levels of biologics for PK calculations, we mostly work with immunology methods such as ELISA, ECLA or RIA, but we also have experience in mass spectrometry of large molecules.
We are fully compliance with the EMA guideline on Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins and other regulations and guidelines of the FDA. Our experience covers a wide range of different kind of large molecules:
Our immunology platform have different technologies available to cover the whole range of needs:
Our mass spec platform counts with 8 LC-MS instruments with different ranges of sensitivity. The strategy to quantify large molecules by mass spec consists on a tryptic digestion of the protein followed by the measurement of the main peptides.
