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Hundreds of thousands of bright pink, white or blue tablets and capsules in all colors of the rainbow drop into bottles on sleek conveyors every hour in a sprawling building — somewhere. Each batch of pills may take a month or more to make.
But now, in a lab near Kendall Square, a team of MIT researchers can turn out 1,000 pills in 24 hours in a device the size of your kitchen refrigerator. It's a whole new way of making drugs.
"We’re giving them an alternative to traditional plants, and we’re reducing the time it takes to manufacture a drug," said Allan Myerson, professor of chemical engineering at MIT.
The Defense Department is funding this project for use in various places like field hospitals serving troops, jungles to help combat a disease outbreak, and strategic spots throughout the U.S.
"These are portable units so you can put them on the back of a truck and take them anywhere," Myerson said. "If there was an emergency, you could have these little plants located all over. You just turn them on and you start turning out different pharmaceuticals that are needed."
Sound simple? It’s not. This mini plant represents a sea of change in both size and operation.
Each tiny pump and chemical reactor in the unit is made or modified to order. "You can't just go out and buy these components," said Klavs Jensen, professor of chemical engineering and materials science at MIT, who is working with Myerson and Tim Jamison, chairman of the chemistry department, on the project.
On the operation side, the device produces medications in a flow or continuous process, which is fundamentally different from the way chemistry has been done for a long time.
"For roughly two centuries, to be honest," Jamison said. "The way that we tend to do chemistry is in flasks and beakers and that sort of thing, and we call that batch chemistry — one batch at a time."
That’s the way virtually all pharmaceuticals are made. You synthesize big batches of chemicals, wait for them to cool down, synthesize again to create new compounds, wait for the compounds to crystallize, filter and dry. Then you add powders to make a tablet or capsule, steps that can take months.
To shift from the batch to a continuous process, "we had to figure out new ways to make molecules and new ways to think about making molecules," Jamison said. "But from my perspective that has also provided us with a lot of opportunities that are very powerful."
The device could increase production of orphan drugs that prevent or treat rare diseases. Some pharmaceutical firms say they can't afford to develop or make small batches of these medications. And all patients might benefit if these devices wind up in hospitals and pharmacies that then make their own pills as needed.
"If it can be done at a lower cost, well now here’s one way at least that we could reduce the exorbitant cost of medications and that could be a social good as well as an economic good for the people who manage to pull this off," said James McQuivey, an analyst at Forrester Research, and the author of "Digital Disruption: Unleashing the Next Wave of Innovation."
The device might make drugs more efficiently than a traditional plant, but most of the cost of an expensive drug is not the materials or manufacturing or transportation, it’s in the drug makers' monopoly control, McQuivey said.
"If we can distribute the manufacturing of anything, pharmaceuticals included, so that more people have the opportunity to manufacture it, well, now there will be competition among those manufacturers," McQuivey continued.
Drug makers have at least two big concerns about the widespread use of this device.
"Intellectual property, that’s first and foremost," said Dr. Paul Beninger, vice president for pharmacovigilance at Sanofi Genzyme.
Pharmaceutical manufacturers own exclusive rights to produce the drugs they develop for a period of time. His other worry: safety. Who would monitor all of these machines to make sure they are making the medication as directed, with no contamination?
"There are some really significant issues that this MIT project has to deal with if they’re going to try and make this a successful venture," Beninger said.
Jensen said continuous monitoring could be built into the manufacturing process with data reviewed at a central location.
The FDA’s Emerging Technologies team has already developed new criteria for things like a 3-D-printed pill.
"I’m confident that this FDA innovative program could do the same with this micro-manufacturing technology," said Lawrence Yu, FDA deputy director of pharmaceutical quality.
On the exclusivity concern, MIT developers are avoiding it for now by producing generic drugs — seven so far, including generic versions of Benadryl, the numbing agent Lidocaine, Valium, Prozac and a common antibiotic. Jensen said pharmacies or hospitals might license the right to produce new drugs using the device in the future.
Myerson, Jamison and Jensen said they expect to seek FDA approval in two years or so for their pharmaceuticals-on-demand unit. By then, it may be even smaller, the size of dorm fridge, and be tuned to produce even more complex drugs.
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