The average cost of developing a new drug is a staggering 1 billion €. All new drug candidates in the development pipeline must undergo a thorough preclinical screening for safety and efficacy before being trialed in humans. Today this requires the use of models that include a combination of cell culture in dishes and animal tests. The major problem with existing models is that they do not predict the results of human clinical outcomes very well. Animals fail to replicate human responses 90% of the time due to species differences, and cell models in dishes still largely lack basic physical stimuli such as flow to mimic blood vessels.
Recent legislation has recognized this critical need for improved models to accelerate drug development, in particular, the need for alternatives to animal models that better mimic human outcomes. Indeed, nearly 200 million animals are used in biomedical research worldwide, a number that could be reduced substantially by alternative technologies that support the “Three Rs principle” (replacement, reduction and refinement) of animals in testing.
One highly promising strategy is a technology called microfluidics. This technology enables the fine control of fluid flow over cells in culture, a hallmark of the native cell environment. Flow enables real-time control of nutrient and gas exchange, drug dosing and residence time, molecular gradients and shear stress. In addition, microfluidics enables the isolation and manipulation of single cells for analysis of cellular diversity and heterogeneity, diagnostics and drug screening at resolution unattainable on a population level.
Innovative dynamic microfluidic cell cultures, particularly organ-on-chip and 3D cell culture platforms, aim at improving drug candidate selection and facilitating trials, and clearly appear to be the next great step for the future of drug research and development. Their use could increase the success of clinical drug trials and decrease R&D costs by 10-26%, as they are more physiologically relevant than static culture flasks widely used today.
However, existing microfluidic sensors for accurately monitoring flow over a relevant
range are the main limiting factor in the use of microfluidics for cell culture, analysis and screening. To solve this important problem and address the main needs expressed by the market and end users, we are developing GALILEO, the first wide-range flow sensor to surpass the state of the art.
