In a lab at
the Massachusetts Institute of Technology, all the work that happens in a vast
pharmaceutical manufacturing plant happens in a device the size of your kitchen
refrigerator.
And it's
fast. This prototype machine produces 1,000 pills in 24 hours, faster than it
can take to produce some batches in a factory. Allan Myerson, a professor of
chemical engineering at MIT and a leader of the effort, says it could become
eventually an option for anyone who makes medications, which typically require
a lengthy and complex process of crystallization.
"We're
giving them an alternative to traditional plants and we're reducing the time it
takes to manufacturer a drug," he said.
The Defense
Department is funding this project because the devices could go to field
hospitals for troops, hard-to-reach areas to help combat a disease outbreak, or
be dropped at strategic spots across the U.S.
"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," Myerson said.
Sounds
simple? It's not. This mini drug plant represents a sea change in how
medications have been made for a long time.
"For
roughly two centuries, to be honest," says Tim Jamison, a professor of
chemistry at MIT and one of Myerson's partners, along with Klavs Jensen, a
professor of chemical engineering at MIT. "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," he says.
That's the
way virtually all pharmaceuticals are made. Big batches of chemicals are
synthesized, then they have to cool down, then are synthesized again to create
new compounds. Then those compounds have to crystallize, filter and dry.
Powders are added to make a tablet or capsule. These steps that can take
months. This new device, says Jamison, produces medicine in one fast continuous
process.
"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," said Jamison. His lab and Myerson's
also are collaborating with the Novartis-MIT Center for Continuous
Manufacturing, which is funded by the pharmaceutical company Novartis.
The
prototype raises the possibility that hospitals and pharmacies could make their
own pills as needed, says James McQuivey, an analyst at Forrester Research.
"If it
can done at lower cost, here's one way at least that we could reduce the
exorbitant cost of medications and that could a social good as well as an
economic good," McQuivey said.
Most of the
cost of an expensive drug is not the materials or manufacturing or transportation
said McQuivey; it's in the drug makers' monopoly control. So, he said, "If
we can distribute the manufacturing of anything, pharmaceuticals included, so
that more people have the opportunity to manufacture it, now there will be
competition among those manufacturers."
Drug makers
have at least two big concerns about the widespread use of this device, says
Dr. Paul Beninger, who oversees pharmaceutical safety at manufacturer Genzyme
Sanofi. He said first and foremost, the drug industry worries about
intellectual property rights.
Drug
manufacturers own exclusive rights to produce the drugs they develop for a
period of time, typically three to five years depending on how much is new in
the drug. His other worry is safety, including monitoring of 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.
MIT
researchers say continuous monitoring would be built into the continuous
production process. The Food
and Drug Administration is working
on how to oversee this type of process.
On the
patent concern, MIT developers say 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,
their focus is on making an even smaller more portable unit, producing more and
more complex drugs and seeking FDA approval for the device.
This story
is part of a reporting partnership with NPR, WBUR and Kaiser Health News.