A team of scientists from Massachusetts Institute of Technology (MIT) have created a portable biopharmaceutical device that can create pre-programmed drugs on demand from raw materials.
The device, financed by the US Defence Advanced Research Projects Agency (DARPA), offers the potential for improved medical interventions at the point-of-care even in remote locations.
Typically, biopharmaceutical drugs such as vaccines and treatments for diabetes and cancer are of limited use within remote areas of the world, as most are produced in large, centralised fermentation plants. Transporting these treatments to such locations may be too expensive, or are simply not logistically feasible.
The laptop-sized portable device harnesses a particular strain of genetically engineered yeast, Pichia pastoris, which is programmed to produce one of two therapeutic proteins when exposed to a certain chemical. This process can then be modified to create any number of therapeutics within 24 hours, in what is called a “millimeter-scale table-top microbioreactor”.
The device would enable healthcare providers to create and provide biopharmaceutical drugs at the point-of-care, even in remote areas. This would effectively bypass logistical problems in sourcing biopharmaceutical drugs from large-scale mass production.
Warren K. Lewis Professor of Chemical Engineering at MIT, Klavs Jensen, said: “The goal of this project was to build a small-scale, portable unit that was completely integrated, so you could imagine being able to ship it anywhere. And as long as you had the right chemicals, you could make pharmaceuticals.”
Associate Professor of Biological Engineering and Electrical Engineering and Computer Science and Head of the Synthetic Biology Group at MIT’s Research Laboratory of Electronics, Tim Lu, said: “Imagine you were on Mars or in a remote desert, without access to a full formulary, you could produce drugs on demand locally.”
The device would have significant applications in precision medicine, allowing the creation of personalised doses of medicine that are tailored to a specific patient. Additionally, the device could also be used to assist population health programmes in remote locations, such as containing disease outbreaks or a public health hazard.
According to the research team, the “synthetic biology” process could be used to develop a vaccine for specific populations, “as different antigens are likely to be optimal in providing immunity depending on geographical location or timing.”
This would enable providers to produce customised vaccines for specific outbreaks and locations, bypassing lengthy and complicated drug manufacturing processes that would require multiple reviews by the US Food and Drug Administration (FDA).
The device also has implications for drug shortages caused by production breakdowns or natural disasters, or aiding clinical trials and the development of so-called orphan drugs.
“We envision that such technologies will enable the creation of small-scale, portable, fully integrated and closed biomanufacturing systems that can advance the treatment of human diseases at the point-of-care,” the researchers concluded.