Emulate said today it will partner with the FDA to evaluate and qualify the company’s Organs-on-Chips technology for toxicology testing to meet regulatory standards for products that include foods, dietary supplements, and cosmetics.

Through a multiyear Cooperative Research and Development Agreement (CRADA) with the FDA’s Office of Foods and Veterinary Medicine, Emulate and the agency will carry out the testing using the company’s Human Emulation System™, consisting of Organ-Chips as well as instrumentation and software apps.

“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,” Geraldine A. Hamilton, Ph.D., Emulate’s president and CSO, said in a statement.

Emulate has developed Organ-Chips that emulate the lung, liver, brain, and kidney. Organ-Chips are living, microengineered environments designed to recreate the natural physiology and mechanical forces that cells experience within the human body. Each Organ-Chip contains tiny hollow channels lined with tens of thousands of living human cells and tissues and is approximately the size of an AA battery.

“Each chip has three microfluidic channels,” Dr. Hamilton told GEN in 2015. “The central channel has a porous, flexible membrane that can be coated with extracellular matrix protein, providing a scaffold to anchor cells in the organ. We then seed the cells in the chip.”

FDA and Emulate researchers will initially use the company’s human, dog, and rat Liver-Chips to conduct studies aimed at assessing cross-species differences in toxicology data between humans and animal species. The partners plan to publish the data and findings from the CRADA studies, Emulate said.

Looking Beyond the Liver

The CRADA collaboration agreement—whose value was not disclosed—allows for future expansion to additional Organ-Chips, including the Intestine-Chip, Lung-Chip, and Cardiac systems. Emulate said it may conduct further training of FDA researchers on the Human Emulation System depending on the evolution of the research and additional areas of interest.

The FDA will review and provide feedback on the performance and application of the Human Emulation System for agency research. Emulate will be able to use information obtained from the FDA for further development and improvement of the system.

The Human Emulation System is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods by recreating the natural physiology of specific human tissues and organs—with greater precision and detail than other preclinical testing methods, according to the company.

Privately held Emulate holds a worldwide exclusive license from Harvard University to the IP portfolio for the Organs-on-Chips technology and related systems. The company’s founding team pioneered the Organs-on-Chips technology at the Wyss Institute for Biologically Inspired Engineering at Harvard University, from which Emulate was spun out.

Since 2012, the FDA has also worked to develop Organs-on-Chips through a public–private collaboration with the federal Defense Advanced Research Projects Agency (DARPA) and the NIH’s National Center for Advancing Translational Sciences (NCATS).

The agencies’ Tissue Chip for Drug Screening program has worked to develop 3D human tissue platforms (or “chips”) modeling the structure and function of human organs—such as the lung, liver, and heart—and then combining these chips into an integrated system that can mimic complex functions of the human body. NCATS says the program aims to improve the translational science process for predicting whether drugs will be safe and effective in humans.

Last month, researchers at Northwestern Medicine published a study in Nature Communications detailing their development of EVATAR, a miniature female reproductive tract made with human tissue as part of the public–private effort. EVATAR consists of divided compartments, each of which contains a 3D model of a different part of the reproductive tract, such as the ovaries, fallopian tubes, uterus, cervix, vagina, and liver.

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