TNO Steps Into Microdosing

Customers will gain the advantages of outsourcing microdosing, toxicological and analytical research to one external partner, TNO. The integrated services will improve the translational aspects of customers’ preclinical development programs.

11 Dec 2009 --- Independent research organization TNO has signed a contract to purchase an Accelerator Mass Spectrometer (AMS), a tool that supports microdosing studies in humans. This state-of-the-art technology will generate human kinetic data on drug candidates and innovative food ingredients earlier than is currently possible. This will significantly reduce the need for animal testing prior to clinical phases and supports TNO’s aim to reduce the cost and duration of drug and food development.

TNO will be the first organization in continental Europe to offer these innovative AMS services to pharma, biotech and innovative food companies.

Customers will gain the advantages of outsourcing microdosing, toxicological and analytical research to one external partner, TNO. The integrated services will improve the translational aspects of customers’ preclinical development programs.

Dr. Wouter Vaes, technology manager microdosing research: "The purchase of the AMS is part of TNO’s overall strategy to help the pharma industry make drug testing more efficient. We are excited by the potential of the AMS to contribute to better development strategies and in the end to better new drugs and foods."

In microdosing, human volunteers are given a 14C-labeled bioactive ingredient at such a minute dose that safety can be assured. Blood is sampled from volunteers at distinct time intervals. Scientists then analyze the samples using the AMS. Since the AMS can detect trace amounts of 14C, concentrations of the bioactive and its metabolites are determined and used to obtain the absorption, metabolism and excretion rates. This information is essential for companies to determine the further development of candidate drugs or food ingredients. Thus, microdosing will allow companies to focus their clinical development programs on those candidates with the most suitable kinetic profile in humans.

TNO is able to make the sizeable investment in the AMS, thanks to subsidy from the Ministry of Economic Affairs. The Ministry’s Director-General Business and Innovation, mr Renée Bergkamp, recognizes the potential of the AMS as part of the governmental innovation program Assuring Safety without Animal Testing (ASAT). The AMS system will be supplied by High Voltage Engineering Europe, located in Amersfoort, the Netherlands. In 2010, TNO will organize a symposium on microdosing in cooperation with a number of Dutch organizations (Assuring Safety without Animal Testing, Top Institute Pharma, Food and Nutrition Delta, Netherlands' Biotech Industry Association, and Life Science and Health). All these parties share the ambition of reducing the resources spent on non-viable candidates and the amount of animal testing necessary to bring new drugs and foods to the market.