Peregrion

Over more than a decade, TNO has attained market successes and regulatory approvals to aid pharmaceutical companies in their early clinical development programmes. Several industry-leading companies are already utilising TNO’s microtracer AMS technology. With the Peregrion spin-off, the technology is set to become the global standard for (early) clinical drug development.

Peregrion operates three biomedical Accelerator Mass Spectrometers(AMS) equipped with sample preparation devices that detect, identify, and quantify all human metabolites during Phase 1 clinical trials. The sample combustion technology allows the AMS system to apply microtracer pathway probing with ¹⁴C-labelled substrates, offering unparalleled measurement sensitivity while retaining the required high data richness. The data from these microtracer studies can be sent to regulatory agencies during early clinical development for approval. This new way of working reduces the total development time by as much as two years. In cases of rejection, the initial development costs are significantly lower.

“The microtracer approach [is] one of the most promising animal-free innovation pathways. Pharmaceutical leaders are already embracing our ‘human first, human only’ strategy as the preferred method to obtain drug metabolism data.”
_{Wouter Vaes (on the right), Microdosing and microtracing studies}

The microtracer AMS technology, which TNO is further developing on a broader scale to include biologics and paediatric medicine, presents the biopharmaceutical industry with an opportunity to reinvent the way drug development takes place. Because Peregrion enables important human data to be obtained at a much earlier stage of development, de-risking the development process with costly, labour-intensive and time-consuming animal radiolabelled ADME studies is a thing of the past.

Moreover, because data from these AMS enabled microtracer studies are available earlier in the development process, ADME, Pharmacometrics, PBPK and formulation scientists can be provided with essential data to fine-tune dosing regimens and optimise the further stages of clinical development.