Back in the ancient history of industrial 3D printing — 2016 — ZipDose, made by Ohio’s Aprecia, became the first drug produced with additive manufacturing (AM) available in U.S. pharmacies (or pharmacies anywhere in the world, for that matter). Notably, after nearly a decade, the epilepsy medication remains the only 3D printed medication approved by either the U.S. Food and Drug Administration (FDA) or the European Commission.

However, as I noted in a 2023 interview with Dr. Senping Cheng, founder and CEO of Chinese AM pharma firm Triastek, the fact that ZipDose is still the only 3D printed drug on the market says more about the lengthiness of the FDA approval process than it does about the state of activity in 3D printed pharmaceuticals: research into and funding of the field continue to steadily accumulate. For instance, the Defense Advanced Research Projects Agency (DARPA) just signed an agreement with Aprecia and its longtime collaborator Battelle, a nonprofit research institution, as part of the EQUIP-A-Pharma program that the Trump administration announced earlier this year.

EQUIP-A-Pharma, first publicly unveiled in May, is a collaboration between DARPA and the Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) Office of Industrial Base Management and Supply Chain (IBMSC).

The Aprecia and Battelle study was one of four projects named in the original announcement, with Aprecia now releasing further details on what the work will entail. The primary purpose of the research is to illustrate the potential to shorten pharmaceutical supply chains by producing active pharmaceutical ingredients and the finished medications that include those ingredients at the same site.

3D Printed Tablets.

To that end, Battelle will create “a custom small-scale chemical synthesis platform” to combine with Aprecia’s Z-Form Flex platform, resulting in demonstrator “agile pharmaceutical manufacturing sites” for two different drugs: levetiracetam (the ZipDose drug) for epilepsy and other seizures, and linezolid, for “gram-positive infections” like bacterial pneumonia. Along with generating relevant data, the project aims to increase the commercial appeal of pharmaceutical 3D printing, in part to attract investment capital.

In a press release about the DARPA and HHS funding of Aprecia and Battelle’s EQUIP-A-Pharma project, the president and COO of Aprecia, Kyle Smith, said, “The EQUIP-A-Pharma program provides a critical opportunity to collaborate with public health stakeholders on agile pharmaceutical manufacturing utilizing our 3D printing technology. By collaborating with Battelle and DARPA, we will focus on creating a pathway that ensures Aprecia’s innovative manufacturing processes address unmet medical needs. This commitment will deliver safe and effective medications more efficiently to those who need them most, including military personnel.”

The print bed, known as the “racetrack,” passes under the print head and fusing mechanism on the right. An additional layer is added each time a pill circles the racetrack until the printing is complete.

Despite all the challenges involved in getting new medications approved by regulators, I’m quite sold on the business case for 3D printed pharmaceuticals. Plus, to reiterate, as Triastek, for one, has proven, while the FDA hasn’t fully approved any more 3D printed drugs following ZipDose, progress is still being made on the regulatory front. I think that, soon enough, we will see multiple new 3D printed drugs hit the market: Triastek alone currently has at least three medications with Investigational New Drug (IND) clearance from the FDA, an important first step towards eventual commercial availability.

One major catalyst that could ignite greater interest in and support for AM pharmaceuticals is the Trump administration’s warning that it could gradually raise tariffs on drugs to as much as 250 percent over the next year and a half. Of course, that’s not a long enough timeline to warrant expectations that it could lead to the availability of new 3D printed drugs by the end of it.

However, at the very least, it should incentivize pharmaceutical companies that have already been in the process of developing 3D printed drugs to devote more resources and attention to those R&D initiatives. In other words, we probably won’t see a flurry of new 3D printed drugs arrive on the scene in the next couple of years, but we might very well see such an influx by the end of this decade.

Aprecia’s lab.

Aprecia’s work with Battelle seems especially promising insofar as it’s integrating 3D printing into a novel production process that covers both major phases of pharmaceutical manufacturing. If Aprecia can achieve the same success with its EQUIP-A-Pharma project that it’s grown accustomed to, the company will add a whole new selling point to the case for AM drugs.

Images courtesy of Aprecia