TNO will use the technology to generate human kinetic data on drug candidates, as well as food ingredients, in a shorter time than is possible with currently available methods.
Company technology manager Wouter Vaes told Outsourcing-pharma that: “Microdosing adds a new dimension to [TNO’s] portfolio for pharma and biotech,” and said that the AMS system should be full operational by 2011.
Vaes predicted that demand for microdosing will increase substantially because “early insight into the kinetics of a compound can help a company manage its pipeline, focusing on those compounds with the highest chance of success in humans.
“Additionally, having human data in early development could help small biotech companies increase their chances of attracting investors. TNO aims to contribute to the three R’s by implementing innovative techniques to reduce the use of animal testing.
He went on to explain that: “For microdosing, several disciplines are necessary to complete a research program. First, short term toxicity studies need to be carried out. Secondly, clinical trials with subsequent AMS analysis need to be performed.
“Lastly, we are looking into developing technology to extrapolate low to high dose regimes with PB-PK modeling to round out our portfolio. Clearly, customers will gain time, reduce costs and communication is easier when a customer can rely on one partner for all these activities.”
TNO is buying the AMS from Amersfoort-based High Voltage Engineering Europa, with the support of a grant from the country’s Ministry of Economic Affairs under its Assuring Safety without Animal Testing (ASAT) programme.
Microdosing in Europe
TNO will join York-headquartered Xceleron as one of the few contract research organisations (CRO) in Europe to offer AMS analysis for Phase 0 microdosing to clinical trial sponsors.
Xceleron has pioneered the technology in the region, providing contract services for Big Pharma firms including GlaxoSmithKline (GSK) and its partnerners as well as CROs like Cambridge-based Quotient Bioresearch.
While Vaes' forecast about rising demand may prove to be correct in time, to date Phase 0 studies have not been widely adopted according to the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).
Speaking to Outsourcing-pharma earlier in the year, a CDER spokesman said: "There is still uncertainty as to how well microdoses predict pharmacokinetics of pharmacologically active doses.
"Since the issuance of the "Exploratory IND" guidance by CDER 3 years ago, where micro dosing was recognized as one of the new ways of learning quickly about a drug in humans at early stage, we in CDER have seen only a limited number of applications utilizing this tool."