3D printed skulls? Yep, we can make those. How about 3D printed organs? We’re getting there, too. Now the biggie: 3D printed medicine? Believe it or not, we’ve made it there. 3D-printing technology, it seems, is taking the medical world by storm.
However, that last milestone in the 3D printing world has been put on hold while awaiting approval from the FDA. But once it gains approval, 3D printed medicine has the potential to blow the field of affordable personalized medicine wide open. With its extreme versatility and inherent ability to customize products, 3D printing could radically change the biotech and pharmaceutical industry in the near future.
And now, the big test for 3D printable medicine has been passed. SingularityHub is reporting the FDA has approved the first 3D printed prescription drug, essentially validating the technology as a new heavyweight player in big pharma. “This may be the first truly mass manufactured product made by 3D printing,” said Dr. Michael Cima, a professor at MIT who helped invent the pill-printing technology back in 1997. “It’s revolutionary.”
The particular drug that got the green light is called SPRITAM from a little-known Ohio based drug company called Aprecia. It’s designed to combat seizures and symptoms of epilepsy. Founded in 2003, Aprecia bought out MIT’s pill printing technology with the aim to boost the speed of printing to commercial production rates. Really, that’s the company’s main challenge and achievement, emphasized Cima. SPRITAM shows that manufacturing millions of parts simultaneously with a 3D printer is possible, and that’s revolutionary.
What it also could lead to is the dawn of customizable, personalized medicine. Sure, “each tablet is essentially made one-at-a-time at very high speed by computer control,” says Cima, “that means it’s theoretically possible to tailor each tablet to the individual patient’s needs.”
Think about that for a second: doctors could have the option to adjust drug dosages on the fly. It may even be possible to pack a patient’s entire prescription into one pill that is manufactured at the pharmacy on demand. Imagine no more pill boxes separating dosages into day by day increments.
People are getting excited and really optimistic about this new technology. A chemist at the University of Glasgow, Lee Cronin, is building an all-in-one 3D pill printer (the “chemputer”) and believes that in the future, patients will be able to download blueprints for drugs and print them at home. “Personalization is the ‘sexy’ driver, but I think distribution and reach are the winners here—especially in the developing world,” he noted in the June 2015 issue of The Pharmaceutical Journal.
Now, understandably, there are some real safety concerns surrounding this new technology. Cima cited dose uniformity as one particular concern that has him worried. Companies will have to have quality systems in place to ensure that the labeled dose is actually in the product. “But then it’s not really any different from current manufacturing processes,” he says.
But there are still some major concerns when it comes to this new formula for making medicine. Will the FDA be able to oversee personal pill printing? Should they? If an automated pill printer goes out of whack and misprints medication, would the blame fall on the machine’s manufacturers or the operators (i.e., the patients)? What if the machines were hacked? If people can reverse engineer patented drugs through 3D printing, how can those patents be protected? Will it be a detriment to drug development? And the big unknown: will people be able to hijack pill printers to manufacture illicit drugs?
For the first time in a long while, we are in uncharted territory in the medical industry. It’s a new “Wild West” in the land of 3D-printed pharmaceuticals. But here’s something that we can all agree on: 3D printed medicine is about to take the world by storm.
Photo credit: Singularity Hub