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Animal-Free Method Examines Medications During Pregnancy

An international research team has developed a method to analyze the safety and effectiveness of medications during pregnancy more precisely - completely without animal testing. This innovative combination of three organ models based on human cells and a digital replica of the human body makes it possible, for the first time, to realistically simulate the absorption, metabolism, and transfer of drugs across the placenta from mother to child.

Pregnant women are usually excluded from clinical studies for ethical reasons. As a result, the effects of many medications on expectant mothers and their unborn children remain insufficiently researched. Animal testing cannot replicate the complex physiological conditions of human pregnancy. Human-based methods are therefore necessary to obtain results that are transferable to humans.

A newly published study in the journal Frontiers in Pharmacology closes this gap. The method combines intestinal, liver, and placenta models in the form of so-called organ chips, which are connected via fine channels. These channels simulate blood vessels through which the tested drug circulates. This setup allows researchers to study the drug’s absorption in the intestine, its metabolism in the liver, and its transfer—along with its metabolites—through the placenta. The collected data is then processed using a digital twin, a computer-based model of the human body, to generate realistic predictions for humans.

The development of this model involved the companies Dynamic42 and ESQlabs, as well as the Placenta Lab at Jena University Hospital and the pharmaceutical company Bayer. In a test series with prednisone, a commonly prescribed anti-inflammatory drug, the model demonstrated a high correlation with known clinical data and was able to reliably simulate long-term prednisone intake over several months.

The combination of organ chips and digital twins offers a revolutionary approach to assessing drug safety at an early stage. Pharmaceutical companies can identify potential risks during drug development, leading to better and safer medications for pregnant women. This new technology contributes to a much-needed paradigm shift in drug research—toward faster, safer, and ethically sound drug evaluation.

Reference

Graf K. et al. Digital twin-enhanced three-organ microphysiological system for studying drug pharmacokinetics in pregnant women, Frontiers in Pharmacology 2025; 16: 1528748 >>