FDA Harnessing Technology in Attempt to Improve Product Safety

Program simulates the physiology of the human body to provide a response model to diseases, medications, and chemicals.

The FDA recently entered into a cooperative research and development agreement with Emulate, Inc, a company that created the Organs-on-Chips technology, according to a press release.

Under the agreement, the FDA and Emulate will work together to evaluate and use Organs-on-Chips for toxicology testing used for evaluating food, supplements, and cosmetics.

Organs-on-Chips contain channel lines with living human cells and tissues that show how a certain product may affect humans in real-time. Emulate reported that the chips are approximately the size of a AA battery.

The studies will use Emulate’s Human Emulation System to simulate the physiology of the human body, which can provide a model of human response to diseases, medication, chemicals, and foods with precision, according to the release.

Emulate’s system gives a more precise and expansive look at human responses than current methods, such as cell or animal testing.

“We are excited to begin this relationship with FDA as a potential first step toward accelerating the adoption of our Human Emulation System for broad application as a new testing platform for a wide range of products that are reviewed and approved by regulatory authorities to protect and improve human health,” said Geraldine A. Hamilton, PhD, president and chief scientific officer of Emulate.

The collaboration will be led by the FDA’s Division of Toxicology, which will have the Emulate system onsite. The short-term goal of the partnership is to evaluate and qualify the testing capabilities of the system in correlation with cross-species toxicology data for chemical and microbiological contaminants in food, supplements, and cosmetics, according to the release.

This testing will allow the FDA to review and provide feedback on performance of the system for further FDA research. Additionally, Emulate will be able to use information from the FDA to improve the Human Emulation System.

Initially, the FDA and Emulate will use the Liver-Chip from multiple species to evaluate toxicology data between humans and animals, according to the release. Determining the differences between species may also improve predicting toxicity of medications.

In the future, the agreement may expand to include additional Organ-Chips, including the Intestine-Chip, Lung-Chip, and chips for the cardiovascular system.

“We are looking forward to combining our expertise with leading researchers at FDA to explore how our Organs-on-Chips technology integrates with existing product testing frameworks — opening the potential for a new paradigm for establishing improved standards, creating more predictive models, and helping to better evaluate safe products for human use,” Dr Hamilton said. “We are excited to begin this relationship with FDA as a potential first step toward accelerating the adoption of our Human Emulation System for broad application as a new testing platform for a wide range of products that are reviewed and approved by regulatory authorities to protect and improve human health.”