Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science
How it Began in 2014! (Coverage from Harvard University)
Wyss Institute’s organs-on-chips develops into new company. In order to accelerate the development of new pharmaceuticals, Harvard’s Wyss Institute for Biologically Inspired Engineering announced that its human organs-on-chips technology will be commercialized by a newly formed private company.
The announcement on Monday followed a worldwide license agreement between Harvard’s Office of Technology Development (OTD) and the startup Emulate Inc. The agreement, relating to the use of the institute’s automated human organs-on-chips platform, includes not only pharmaceuticals, but chemical, cosmetic, and personalized medicine products as well.
“This is a big win towards achieving our institute’s mission of transforming medicine and the environment by developing breakthrough technologies and facilitating their translation from the benchtop to the marketplace,” said Wyss Institute Director Donald Ingber, who led the organs-on-chips effort.
Created with microchip manufacturing methods, the organs-on-a-chip are cell-culture devices, each the size of a computer memory stick, that contain hollow channels lined by living cells and tissues that mimic organ-level physiology. These devices produce levels of tissue and organ functionality not possible with conventional culture systems, while permitting real-time analysis of biochemical, genetic, and metabolic activities within individual cells.
The Wyss Institute team also has developed an instrument to automate the organs-on-chips and link them together by a flowing medium that mimics blood to create a human-body-on-chips and better replicate whole body-level responses. This automated platform could represent an important step toward more predictive and useful measurements of the efficacy and safety of potential new drugs, chemicals, and cosmetics, while reducing the need for traditional animal testing. Human organs-on-chips lined by patient-derived stem cells also could potentially provide a way to develop personalized therapies in the future.
The technology’s rapid development, from demonstration of the first functional prototypes to multiple human organs-on-chips that can be integrated on a common instrument platform, also speaks to the institute’s ability to translate academic innovation into commercially valuable technologies in a big and meaningful way.
“We took a game-changing advance in microengineering made in our academic lab, and in just a handful of years, turned it into a technology that is now poised to have a major impact on society. The Wyss Institute is the only place this could happen,” said Ingber, who is also the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and professor of bioengineering at the Harvard School of Engineering and Applied Sciences.
Since their 2010 publication in Science about the human breathing lung-on-a-chip, and with grant support from the Defense Advanced Research Projects Agency, the Food and Drug Administration, and the National Institutes of Health, Ingber and his team have developed more than 10 different organ-on-a-chip models, including chips that mimic liver, gut, kidney, and bone marrow
The transition of the organs-on-chips technology to a startup was enabled by the Wyss Institute’s technology-translation model, which takes leading high-value technologies that emerge from faculty efforts and “de-risks” them technically and commercially to increase the likelihood of their commercial success.
The organs-on-chips project leaders included Ingber, Geraldine Hamilton, lead senior scientist on the biomimetics microsystems platform, and James Coon, an entrepreneur-in-residence at the institute. Hamilton and Coon will take senior leadership positions at Emulate, along with multiple members of the research team, smoothing the transition from academia to industry.
“The organs-on-chips story is a great example of how the Wyss Institute brings researchers with industrial experience into the heart of our research community and effectively bridges academia and industry,” said Harvard Provost Alan M. Garber, chair of the Wyss Institute’s Board of Directors.
How it turned out by 2017! (Coverage from FDA)
There are many things you might envision putting on a chip. It’s unlikely that a human organ is one of them.
But creating human organ systems in miniature on micro-engineered chips about the size of a AA battery is a revolutionary testing technology that has captured the attention of food scientists at FDA. And FDA has a leading role in evaluating this science, designed to provide a more precise model for studying the effects of potentially harmful chemical and biological hazards in food, cosmetics or dietary supplements than is now available.
On April 11, 2017, FDA announced a multi-year research and development agreement with a company called Emulate Inc. to evaluate the company’s “Organs-on-Chips” technology in laboratories at the agency’s Center for Food Safety and Applied Nutrition, one of a number of FDA efforts to help evaluate this chip technology. The flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body. The chips are translucent, giving researchers a window into the inner workings of the organ being studied.
Research will begin with a liver-chip but the agreement may expand in the future to cover additional organ-chips, including kidney, lung and intestine models. The ultimate goal is to predict how specific organs will respond to exposure to potential chemical hazards found in foods, cosmetics and/or dietary supplements with greater precision than other methods currently being used, such as cell-culture or animal-based tests.
Organs-on-chips have been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH) since 2012. Millions of dollars in grants have been awarded to universities nationwide to advance this research, including Harvard University and the Massachusetts Institute of Technology. Emulate was founded by researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University.
The chips were first developed to evaluate the effectiveness of drugs but have come to be seen as a potentially useful technology in our efforts to ensure the safety of the foods and cosmetics we regulate. For example, they 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.
In some ways, science is like a recipe in that both can go through a number of incarnations before they work. There’s a lot of experimenting and tweaking, collaborating and comparing. And that’s what we’ll be doing at FDA with the organs-on-chips research. Science is the foundation of FDA’s decisions but many people don’t realize how much scientific research is conducted by the agency. We’re excited to be at the forefront of this ground-breaking research, which may one day be routinely used to safeguard public health.
Wondering how this Organs-on-Chips technology works? Click here.