What Happened to 3D-Printed Drugs?
Healthcare is usually seen as pretty recession proof. After all, when things head south, our health can go sideways. But the current pandemic has reportedly wiped out 1.4 million jobs in the medical field. (Do you really want to go in for that nose job and leave with a potentially deadly pulmonary infection?) While the layoffs are mainly blamed on a precipitous drop in highly profitable elective surgery, you’ve got to figure that the healthcare industry may take this opportunity to further automate hospitals with robots and use artificial intelligence to manage clinical workloads. A third technology that has begun to disrupt healthcare is 3D printing, from bioprinting human tissue to medical devices for 3D diagnostic models, with major 3D printer manufacturers like Formlabs going all-in on medical applications. Now we have 3D-printed drugs.
What Are the Benefits of 3D-Printed Drugs?
Don’t get too excited. This doesn’t mean you can suddenly turn your desktop 3D printer into a meth lab – at least not yet. The basic idea is to tweak standard inkjet 3D printing technologies, which extrude a material through a small nozzle that is cured and hardened layer by layer, for manufacturing medication. Apparently, there are a ton of benefits to this process, beginning with the concept of precision or personalized medicine in which a drug is customized for a patient. We recently talked about this in regard to precision oncology.
The old-fashioned method of preparing oral drugs involves the mixing, milling, and compressing of powdered ingredients. It’s easy, accurate, and relatively cheap but there’s no allowance for variation. In the case of 3D-printed drugs, formulations for oral tablets can be targeted to a person’s biology based on age, race, and maybe even genetics to increase efficacy or reduce side effects.
That’s not all. Think of the potential to produce small batches of AI-generated drugs for an AI-run clinical trial. Or 3D-printed drugs on demand for people with rare disorders that require expensive medications because of limited demand. One can even imagine a 3D-printed drug version of the multi-vitamin, where a multi-dose pill can address both your high blood pressure and low libido. And all of this could happen at the point of care or local pharmacy. Compounding pharmacists might become a thing of the past, which may not be a bad thing in some cases.
What is the Market for 3D-Printed Drugs?
So why don’t we already 3D print drugs like the Fed prints money? Big pharma is certainly toying with the idea. We read recently that Merck (MRK) has entered into a partnership with a German 3D printer manufacturer to streamline “the production process of drug manufacturing by using the 3D printing technology” by saving “time for formulation development as well as reduce costs.” GlaxoSmithKline has also been in the conversation around integrating 3D-printed drugs into its portfolio of medicine-making technologies.
But we’ve also read in a pharma industry publication that some big brains have been working on 3D printing drug technology since at least 1997. A UK professor of pharmacy with some serious credentials recently said in an interview that 3D printing is at “the stage where a lot of people have shown that you can make many different types of dosage forms.” But, he added, the economics don’t yet make sense, at least not when it comes to scale. That seems a bit counter-intuitive given that the appeal of 3D-printed drugs is for personalized medicine and small-batch manufacturing.
An FDA-Approved 3D-Printed Drug
The company that has become the de facto face of the 3D-printed drug market is Aprecia Pharmaceuticals, which was founded way back in 2003 outside of Philadelphia. The company has raised $158.4 million in disclosed funding. The last round was in 2016, suggesting that the company is perhaps spending its pennies wisely and maybe even making a profit?
Aprecia’s 3D printing technology, ZipDose, was originally developed at MIT. The method involves layering powdered material of the drug with a binding liquid up to 50 times. The highly porous structure of the 3D-printed drug means that it can dissolve and disperse within a few seconds, like when an Alka-Seltzer goes fizz, fizz. It can deliver doses of up to 1,000 milligrams, as compared to about 200 mg for a typical tablet. The company’s first product is called Spritam, an anti-epileptic medication and the only 3D-printed drug presently approved by the FDA.
Aprecia certainly doesn’t intend for Spritam to be the last 3D-printed drug. News recently emerged that it would partner with UK-based Cycle Pharmaceuticals to manufacture drugs for the treatment of rare diseases using ZipDose. The company also recently announced it would work with Purdue University on several fronts: “exchange of faculty and research scholars; access to highly educated students; and joint collaborations in research and discovery, learning and teaching, engagement and technical assistance.” In other words, Aprecia gains access to cheap labor in the form of grad students and Purdue can ensure its tenured faculty have time for sabbaticals. Win-win.
A New 3D Printer for 3D-Printed Drugs
Aprecia certainly isn’t the only startup working on 3D-printing drugs. Founded in 2014, FabRx is a British spin-out from University College London that has raised at least more than $6 million in various grants. The company just released its first commercial product a couple of months ago. The M3DIMAKER uses fused deposition modeling 3D printing technology to melt a mixture of drugs and excipients through a nozzle onto a build plate that constructs a tablet or pill layer by layer. FabRx manufactures its own filaments, comprised of pharmaceutical-grade materials, which can be drug-loaded to create sustained or delayed-release tablets. It comes with three different printing nozzles that allow users to adapt the system to their manufacturing needs.
The machine incorporates a fingerprint access control to ensure that young Johnny can’t make his own ritalin cocktail. FabRx refers to the various types of 3D-printed drugs as printlets. It can be used for personalized dosage, clinical trials, and to produce combinations of multiple medications into a single “polypill” for patients in complicated relationships. Depending on the medicine being made, the M3DIMAKER can crank out a month’s supply of medication (28 printlets) in about eight minutes.
The company is also working on a range of other 3D printers using familiar technologies like selective laser sintering, which uses a laser to convert a powder material into solid parts. In the case of 3D-printed drugs, FabRx can incorporate drugs into the powder to produce drug-loaded printlets with special properties such as controlled release.
It seemed like 3D-printed drugs were poised to hit the mainstream in 2015 when Aprecia Pharmaceuticals got the green light from the FDA for its anti-epileptic medicine. And then … crickets for the most part. The increasing emphasis on personalized medicine in healthcare, however, may be exactly what the doctor ordered for the 3D-printed drug industry. Don’t forget it was only a couple of years ago that SmileDirectClub (SDC) burst onto the scene with its 3D-printed clear aligners for straightening your teeth at home. Now many of the major manufacturers are designing specialized 3D printers for dental offices. We wouldn’t be surprised if 3D-printed drugs become one of those bandwagon technologies that are suddenly everywhere.
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