MIT Researchers Seek FDA OK for Mini Drug Maker
Researchers at the Massachusetts Institute of Technology are seeking FDA approval for a drug manufacturing plant that is the size of a home refrigerator and can produce 1,000 pills in 24 hours, faster than it takes to produce some batches in a conventional drug manufacturing facility. Kaiser Health News reports that chemical engineering professor Allan Myerson says the new machine could eventually become an option for anyone who makes medications, which typically require a lengthy and complex process of crystallization.
The research is being supported by the Defense Department, which sees the potential in placing the machines in field hospitals, hard-to-reach areas to help fight a disease outbreak, or dropping them at strategic spots across the U.S. The researchers also are collaborating with the Novartis-MIT Center for Continuous Manufacturing, funded by Novartis.
“If there was an emergency,” Myerson says, “you could have these little plants located all over. You just turn them on and you start turning out different pharmaceuticals that are needed.” While it sounds simple, Kaiser Health News says it “represents a sea change in how medications have been made for a long time.”
MIT chemistry professor Tim Jamison says “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. We had to figure out new ways to make molecules, new ways to think about making molecules, but from my perspective that has also provided us with a lot of opportunities that are very powerful.”
Forrester Research analyst James McQuivey tells the news service that the prototype raises the possibility that hospitals and pharmacies could make their own pills as needed. “If it can be done at a lower cost,” he said, “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.”
The report says that drug manufacturers have at least two major concerns about widespread use of the technology. First, according to Genzyme Sanofi’s Paul Beninger, who oversees pharmaceutical safety for the company, is the issue of intellectual property rights. He noted that drug manufacturers own exclusive rights to produce drugs they develop for a period of years. His other concern is safety, including monitoring of the machines to ensure quality and safety. “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,” he said.
The researchers say that continuous monitoring would be built into the production process and that FDA is looking at ways to oversee this type of process. With regard to the intellectual property concern, they say that the device is being tested to make generic drugs for now, but that pharmacies or hospitals might someday license the right to produce drugs that have just been approved, not existing ones. For now, they say, their focus is on making an even smaller, more portable unit, producing more and more complex drugs, and seeking FDA approval for the device.