Discussion

A novel ultra-sensitive assay will be presented for preclinical studies with innovative medicines. The assay is up to a factor 1.000 more sensitive than conventional techniques, down to 0.01 attomoles/L. It is especially useful for minute sample amounts and performing analyses at very low concentrations. The technology is based on proprietary methods for labelling of biologics and sample preparation and subsequently ultra-sensitive measurements by mass spectrometry. Newly developed drugs can be tested for their pharmacokinetic profile in preclinical (animal) studies, bio-availability or phase 0 (human) studies. The technology can be applied to biotech drugs like antibodies, proteins and peptides, oligonucleotides and nanomedicines. The assay, already in service, is in plans to be developed even further to face more challenges in drug discovery. We have successfully applied our method for biotech companies to investigate various (modified) proteins, such as EPO, GCD, CSF, antibodies and leuprolide.