With the US FDA approval of a 3D bioprinted drug in 2016, the floodgates have been opened for a new wave of innovative, personalized and customizable printed medicine.
Printing tailored medicine could simplify our supply chain dramatically.
Martin Wallace, GSK
3D Bioprinting on the Rise
Many healthcare and life science companies are investing in 3D bioprinting and are cognizant of the potential that the technology can bring. The US-based Organovo has already had some success in printing parts of lung, kidney and heart muscle and is working with Roche on assessing drug-induced toxicity on simulated liver tissue and with L’Oreal to test potential product side-effects on artificial skin. While plenty of research is being directed towards bioprinting a working, transplantable human organ, this is proving to be hugely complex due to difficulties in creating blood vessels and capillaries. NASA has even offered a USD 500,000 prize for the first research team to manufacture a working vascular system.
Although a 3D printed human organ is some way off coming to market, 3D printed drugs are already being made available to patients. Spritam (levetiracetam), an oral drug for epilepsy patients suffering from seizures manufactured by Aprecia Pharmaceutical, became the first 3D bioprinted medication to gain FDA approval in March 2016.
Unlike conventional production techniques, the 3D printing process for Spritam does not rely on compression forces, punches, or dies. Instead, it binds layers of powdered medication together with an aqueous fluid. This forms medicine that is solid, yet very porous. The porous design helps the medication to rapidly disintegrate when taken with a sip of liquid, creating a medication suitable for patients who struggle to swallow tablets capsules or pills, dislike the texture and/or taste of liquid medicine, or who have trouble measuring precise doses of liquid medicine. Martin Wallace, director of technology at British pharma giant GSK, comments that Spritam represents “an almost instantaneous release of the drug, with a very high drug loading, which is difficult using conventional technology.”
Big Pharma Keeping an Eye
GSK itself is investigating the advantages that 3D printing could bring to the manufacture of pills and tablets, specifically in the field of personalized medicine. Wallace explains, “Because personalized medicine has the ability to stratify patient populations and segregate them in a more precise manner, it means that we can provide more specific solutions for that patient,” he continues. “Printing tailored medicine could simplify our supply chain dramatically.” Wallace feels that 3D printing can also unlock the ability “to create complex shapes and geometry in order to deliver the drug in a different way.” The drug loading, release, and taste of a medicine can all be altered by changing the geometry of a tablet.
Wallace does, however, caution that, 3D printing will not replace today’s production methods for some time. “Current technology allows us to produce up to 1.6 million tablets per hour,” he notes. “You’re going to need a lot of printers to achieve that sort of production.”