Massachusetts Institute of Technology (MIT) researchers have devised a miniature drug laboratory—about the size of a college dorm-room refrigerator—that could decentralize the way drugs are made.
The lab-to-go is driven by a microfluidic chip, which modulates the fermentation of genetically altered yeast to produce a wide variety of medications.
“Our goal is to decentralize drug manufacturing and allow portable, on-demand drug production anywhere,” says Timothy K. Lu, M.D., Ph.D., an associate professor of synthetic biology at MIT and a lead researcher on the project.
“We believe that decentralized drug manufacturing has the potential to upend the current status quo for the drug market, and by enabling a platform akin to ‘3D printing for drugs,’ should help to drive pressure on drug costs,” Lu says.
While the lab is currently run by MIT students and postdocs, Lu’s long-term goal is to put the technology in the hands of as many medical personnel as possible. “In the future, we anticipate making the system easy to use by medical staff with minimal training, and we believe this should be possible given the tools we have developed,” Lu says.
Most of the ingredients needed to produce a wide variety of drugs with the lab are readily available. “It’s very similar to what you’d need to make beer,” Lu says.
The prototype—which was funded in part by the U.S. Defense Advanced Research Project Agency—makes drugs by delicately fermenting what’s known as a ‘trigger chemical’ with genetically altered yeast. Combining such yeast with estrogen in the lab, for example, produces a dose of human growth hormone. Synthetic yeast combined with methanol produces a dose of interferon.
Altering the yeast’s genetic code is key to the drug-making process. “The range of medications that can be produced is quite broad, and only really requires engineering the right genetic code into the cells, which is straightforward,” Lu says.
Also key to the process is the microfluidic chip that drives the fermentation process. It was developed by an MIT team led by professor of electrical engineering Rajeev Ram, and is commercially available from Pharyx, Inc. Essentially, the chip continually monitors and tweaks oxygen levels, temperature, pH, and other factors during the fermentation process.
“Tim's lab has inserted synthetic components into the genome to make the cell responsive to external chemical stimuli, and upon stimulation, produces specific useful therapeutic proteins,” Ram says.
The chip modulates gene circuits in the yeast to produce a specific drug, Ram adds.
“It is a pragmatic solution for bio-manufacturing,” says Luke P. Lee, a professor of bioengineering at the University of California, Berkeley, who is not involved in the project.
So far, Lu says he and his team have produced a wide variety of drugs with the lab. “Ultimately, the platform should be capable of making any protein drug, which encompasses antibodies, enzymes, hormones, and others,” Lu says.
The personalized nature of the lab—that is, its ability to make a single dose of medication at a time—offers great promise to doctors who are looking to create highly personalized therapies for their patients on the fly. For example, the lab can be used to create a highly specialized vaccine for a particular strain of virus, or a treatment for a highly specific form of cancer.
“We are actively looking at cell and gene therapies where a small population of a patient's own cells are reprogrammed to fight disease—and potentially cure cancer,” Ram says.
The portable lab could also be a boon to doctors working on battlefields or in remote parts of the world, where a sorely needed drug for a specific ailment is simply not available, Lu says.
With the lab, a few doses of the right medication at the right time in a remote village, for example, could prevent the widespread outbreak of disease, Lu says.
Before the portable drug lab can become commercially viable, MIT researchers need to engineer a purification module for the system. They also need to add on-board analytics, to verify the formulaic integrity of the drugs it produces.
“Fortunately, the liquid samples are already quite clean; these particular cells produce very little unwanted protein,” Ram says. “The remaining purification involves selective binding and release of the protein and suspending it in a solution where it can be stored.”
As for analytics, “Recently, we have been developing spectroscopic tools and applying simple machine learning algorithms to build robust classifiers for the various end-products,” Ram says.
Joe Dysart is an Internet speaker and business consultant based in Manhattan.
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