HepMetPro

During the development of an ex vivo porcine whole-liver perfusion model, experts at TNO uncovered the ability to produce milligrams of drug metabolites that the human liver would normally produce in clinical studies. This development can accelerate any stage of the drug development process during which metabolite studies are needed.

Different from chemical or bacterial extraction methods, which often take weeks or months to complete and produce mere micrograms of the needed metabolites, HepMetPro enables the concurrent production of several milligrams of occurring metabolites in a single day. This can vastly accelerate drug development, and enable researchers to have a swift supply of metabolites they need to thoroughly study them. What’s more, metabolite production occurs in a way that is similar to the human liver.

As part of TNO’s Tech Transfer program, HepMetPro is now available to any interested pharmaceutical or research partner. Although it is anticipated that HepMetPro will eventually spin off and become an independent company, the technology is already available for use. Pharmaceutical companies need only ship their parent drug to our perfusion facility. The parent drug will undergo a normothermic liver perfusion experiment with a continuous (increasing) dose of the test compound. If renal metabolites are also of interest, liver/kidney perfusion can be combined. After approximately 24 hours, blood (perfusate), bile and urine (if needed) is collected and returned to the study sponsor. If desired, of course TNO has extensive capabilities to isolate and purify specified metabolites on site, although many sponsors might have these capabilities themselves. Materials like blood (perfusate), bile, urine and/or purified metabolites will be shipped immediately to the sponsor.

The HepMetPro facility is able to handle isotopically or radio-labelled drugs to produce isotopically or radio-labelled metabolites, which could be of use as LC-MS internal standards or quantitative reference standards for metabolite profiling studies.

The HepMetPro Tech Transfer is yet another example of how TNO is helping drive the drug development industry forward with methodologies that accelerate and streamline development phases. By providing highly translational, accurate, and effective techniques and insights, pharma and research organisations require less reliance on sub-optimal animal models, and gain better insight into the safety, efficacy, and behaviour of novel drug compounds.

Want to learn more about HepMetPro or produce milligrams of metabolites faster than ever before?