Faster registration of new drugs by label free human mass balance studies

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In collaboration with four partners from the pharmaceutical industry, TNO aims to develop a sensitive AMS (Accelerator Mass Spectrometer) method for the generic detection of drug compounds present in human matrices and hereby  aimed to speed up drug development by conducting label-free mass balance studies rather than 14C-labelled compound.

For registration of new small molecule drugs, human mass balance studies are required to substantiate that the fate of the drug is thoroughly understood. These mass balance studies, normally executed with 14C labelled drugs, are high cost studies and are therefore generally in the critical path to registration. However, a labelled drug is not necessary for all commercially available drugs. For a specific selection of compounds under development it is possible to execute mass balance studies without any additional label, and suddenly for these drugs, any human clinical trial would become potentially a human mass balance study. This would save a tremendous amount of costs and time, and, more importantly, this would take the human mass balance study out of the critical path. Time to market would be shortened by up to one full year.

Within this project, the partners investigate the possibility to analyse drug compounds, that meet the criteria for this innovative approach, in physiological fluids (urine, plasma, faeces) in the low pg/mL range by Accelerator Mass Spectrometer (AMS). Currently there are no generic analytical techniques available that could provide mass balance data directly from any clinical trial with unlabelled compounds.

This project will result in a proof of concept, for both technical (AMS tuning) and analytical (sample preparation) aspects. If successful, it will result in generic methods, qualified  according to European guidelines, which can be used in clinical studies.

See website for more information.

Summary
The aim of this project is to develop a sensitive AMS (Accelerator Mass Spectrometer) method for the generic detection of drug compounds present in human matrices and hereby aimed to speed up drug development by conducting label-free mass balance studies rather than 14C-labelled compound. There is no need for radio-synthesis (saving time and money) and each clinical study can be a mass balance study.
Technology Readiness Level (TRL)
3 - 5
Time period
24 months
Partners