A new technology has the potential to help scientists gain a better understanding of the effects of harmful materials in foods, medicines, dietary supplements, chemicals, and cosmetics in humans. In April, FDA announced a multi-year research and development agreement with Emulate Inc. to evaluate the company’s Organs-on-Chips technology in laboratories at the agency’s Center for Food Safety and Applied Nutrition (CFSAN).
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“We are always looking for scientific innovations that will provide more precise models for studying the effects of potentially harmful chemical and biological hazards in these products,” says Suzanne Fitzpatrick, PhD, senior advisor for Toxicology in the FDA’s CFSAN.
Researchers at the Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, Mass., developed organs-on-chips and licensed it to Boston start-up Emulate Bio. Robert Cunningham, BS, platform development director at the Wyss Institute, explains that currently there are only three ways to test new drugs and food products for safety and effectiveness. These include testing in volunteer human subjects, which is expensive, time consuming, and potentially hazardous; testing in animals, which is expensive, poses ethical issues, and may not predict human responses; and testing in human cells grown outside body—a standard method for more than a century. “None of these techniques are very satisfactory, which leads to a lot of failures in the development of new drugs and food products,” he says. “We saw an opportunity for an innovative approach that addresses short comings in current methods.”
Dr. Fitzpatrick says the flexible polymer organs-on-chips contain tiny channels lined with living human cells that are capable of reproducing blood and airflow just as in the human body. The chips are translucent, giving researchers a window into the inner workings of the organ being studied.
Cunningham believes the organs-on-chips developed by researchers at the Wyss Institute and licensed to Boston start-up Emulate Bio are a better testing method because they don’t involve human or animal subjects. “By carefully designing the environment of the cultured cells on micro-fluidic chips, the cells behave much more like they are actually in the human body,” he says. “We fool them into thinking they are not in a lab dish. The result is a more accurate response.”
Dr. Fitzpatrick says the chips can be put to work to see how the body processes an ingredient in a dietary supplement or a chemical in a cosmetic and how a toxin or combination of toxins affects cells, information that ultimately can be used to help assess risks to human health.
Researchers have high expectations for the new technology. “The hope is that the organs-on-chips provide a significant advancement in tissue culture techniques that are available to research scientists evaluating new foods, drugs, and cosmetics in a safer and less expensive way, and that these tests will be more predictive of how patients or consumers will respond when they use new products,” Cunningham says.
Cunningham adds that research on one particular chip, the spleen-on-chip, has already led to an offshoot technology that is currently being used for food safety and quality testing.
“We can capture pathogens, contaminants, or spoilage organisms directly from food using spleen-on-chip technology,” says Michael Super, PhD, lead senior staff scientist at the Wyss Institute. “For example, in one hour we can extract spoilage organisms from yogurt for further testing while current methods take many hours to days to do this.”