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The pioneers of 3D printed pharmaceuticals

A look at the state of 3D printed medication and who is leading the nascent segment forward

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One of the most exciting applications for additive manufacturing in the world of healthcare is in pharmaceuticals, where a small but growing number of companies are developing solutions to 3D print medication. The potential here is massive, as 3D printing can unlock a whole array of benefits, such as personalized doses, improved drug administration, faster drug development, and point-of-care manufacturing. In this article, we’ll look at these advantages, the challenges still facing the emerging segment of 3D printed drugs, and which companies are leading the industry forward.

What 3D printed medication offers

To begin, 3D printed medication is still a segment still very much in its infancy. While a select number of 3D printed medications have been approved for use, the widespread roll-out of 3D printed drugs has largely been limited by the stringent regulations of the pharmaceutical industry and very established workflows and processes. However, the pharmaceutical industry is well aware of the benefits 3D printing can offer and it’s clear that it sees the technology as a part of the future of drug development and drug administration.

In drug development, 3D printing can and is being used to rapidly produce small batches of medications made up of varying formulations. The ability to print these experimental drugs on demand and in house enables researchers to evaluate medications more quickly at preclinical stages and to rule out certain formulations earlier on and focus time and resources on the most promising ones.

Arguably the most radical benefits of pharmaceutical 3D printing are related to drug administration. For starters, 3D printed medication would signal a shift away from mass-produced, one-size-fits-all dosages. Instead, dosages could be customized to the patient, reducing the need to take multiple tablets or having to cut drugs in half. It is also possible to combine multiple drugs into a single pill, which would make drug administration much simpler. No longer would polymedication be a challenge for patients requiring multiple tablets per day as a bespoke combination of active ingredients could be combined in a single pill.

Another big opportunity presented by 3D printed medication is improved and customized release profiles. For example, 3D printing can create tablets in different shapes and geometries to control how an active ingredient is released for more efficient dosing. The design freedom unlocked by 3D printing could also be harnessed to produce pills that are easier to swallow.

There is also interest in leveraging 3D printing to provide point-of-care drug production. This means that 3D printers could be used in pharmacies or other medical facilities to manufacture personalized drugs on demand, which would help to overcome supply chain issues, minimize wait times, and reduce waste (particularly for medications with limited shelf life).

The pioneers of 3D printed pharmaceuticals - a look at the state of 3D printed medication and who is leading the nascent segment forward.

What is holding 3D printed pharmaceuticals back?

While a number of GMP-conforming technologies for printing medications exist, it is likely a long road to 3D printed pills becoming a common prescription. Not only is it a matter of the technologies still being relatively new (or very new in some cases), but the strict regulatory framework of the pharmaceutical industry takes a long time to adapt. For instance, the structure of the current pharmaceutical market has to contend with the introduction of 3D printing for drug production.

While it is currently highly centralized with a select number of manufacturers, the introduction of 3D printing would bring with it all the changes of a decentralized supply chain. This means that pharmaceutical regulatory bodies need to establish a new framework for regulating medications that are made not in pharmaceutical factories but in healthcare settings. The good news is that new frameworks are being investigated by agencies in various parts of the globe, such as the UK, which has drafted a regulation strategy for point-of-care 3D printed drug production, and the U.S., where the FDA’s Office of Testing and Research is studying 3D printing in the pharmaceutical industry with the aim of developing standards.

There are also technical challenges to address. For instance, researchers at University College London found that certain active ingredients could not successfully be printed using SLA-based processes. In extrusion-based solutions that require heat, applications are also limited for active ingredients with thermal instability. There is therefore a need to further advance the development of excipients that meet both printing requirements and healthcare standards. There is also a need for stringent in-process controls and monitoring to ensure that tablets are printed with precision and without defects.

Who is printing drugs?

As we said, the 3D printed drug market is still limited, though there are a growing number of startups and much innovative research being done. Here are the main medtech companies leading the push for 3D printed medication.

Aprecia Pharmaceuticals

Aprecia Pharmaceuticals was founded in 2003 with the aim of using 3D printing technologies to minimize ‘pill burden’ and make medication administration easier. To this end, the company has developed a proprietary process called ZipDose Technology. ZipDose is currently the only FDA-approved product for commercial-scale pharmaceutical printing. The technology itself is based on a powder binder jetting approach and does not require the use of any heat. Instead, it relies on an aqueous fluid to bind multiple layers of powder together. The result is a fast-dissolving tablet that can be filled with customized doses of up to 1,000 mg. These tablets dissolve within seconds when exposed to water, making oral administration easier. Aprecia’s ZipDose technology already has a commercial application: since 2016, it has been used to produce SPRITAM, a drug used to treat seizures. The rapid-dissolve nature of the medication makes it easy to administer to children as young as four, who may struggle to swallow more traditional tablets. SPRITAM is the first 3D printed drug approved by the US Food and Drug Administration.

Doser

Dutch company Doser is (in its own words) on a mission to revolutionize how medicine is delivered. The company’s DoseRx1 system is an open, GMP-qualified 3D printer capable of printing tablets with customized dosages of medication inside. The machine uses quality-controlled, refillable cartridges that contain the required formulations for printing medication. Users simply have to insert the stainless steel cartridge and select the proper dosage in the 3D printer menu. The machine, which can print 80% of all oral active pharmaceutical ingredients (APIs), can print semi-solid or liquid formulations at a rate of between 100 and 1000 doses per hour and can operate at a low temperature to maintain the quality and efficacy of the active ingredients. Doser’s platform was recently adopted by Transvaal Apotheek, a Netherlands-based specialist in pharmacy compounding and tailored medicine.

The pioneers of 3D printed pharmaceuticals - a look at the state of 3D printed medication and who is leading the nascent segment forward.
3D printed medicine from the University of Nottingham.

Exentis

While German company Exentis Group AG isn’t printing pharmaceuticals itself, it has developed a proprietary 3D screen printing technology that can be used in cleanroom environments using a variety of materials, including bioprinting and pharmaceutical products. The technology was recently demonstrated when Exentis 3D printed 6,000 metal microfilters in under 30 minutes and has just been adopted by an Italian CDMO pharmaceutical company. In a pharmaceutical context, the technology could be viable for mass-producing tablets with “flexibly definable release profiles”, with a single system capable of printing up to 200 million tablets per year. According to the company, which is IPO-ready, its 3D screen printing platform is already being used to develop drugs for diabetes, epilepsy, and Parkinson’s disease, while other application areas include nutritional supplements and veterinary medication.

FabRx

British biotech company FabRx, founded in 2014 as a spinout of University College London, is a pioneer of 3D printed pharmaceuticals. Today, the company sells two printing platforms for making personalized printlets: the M3DIMAKER 1, a single-printhead system designed for R&D and small batch production, and the M3DIMAKER 2, a multi-printhead system with higher throughput capabilities. FabRx’s technology offers an exchangeable printhead system, which enables users to work with semi-solid extrusion, fused deposition modeling, or direct powder extrusion. FabRx’s hardware is accompanied by a software platform and pharma-ink development services (i.e. FabRx works with customers to develop and validate different active ingredients in printable form). In addition to printing customized doses, FabRx’s technology can personalize other variables, like the tablet’s flavor and color. It can also combine multiple drugs in a single tablet when possible.

MB Therapeutics

Founded in 2022, MB Therapeutics was born out of a research collaboration between the Faculty of Pharmacy at the University of Montpellier, the University Hospital Center of Nîmes in France, and Lynxter, a Bayonne-based company specialized in the development of industrial 3D printing systems. The young company is building an ecosystem for developing and manufacturing personalized 3D printed medicine. At the center of this ecosystem is the MED-U Modular, a 3D printer that extrudes gels or pastes with precision onto a removable build surface made of a food/pharmaceutical-grade material. MB Therapeutics is primarily looking to transform drug administration for children and is aiming to have its printed personalized medications available by 2026. Currently, the company is working with customers on formulation development, which involves characterizing active ingredients, developing formulations, optimizing the 3D printing process, and producing technical batches for trial.

The pioneers of 3D printed pharmaceuticals - a look at the state of 3D printed medication and who is leading the nascent segment forward.

Merck

Medtech startups aren’t the only ones pursuing 3D printed medication: large pharmaceutical companies are also exploring the possibilities. In 2020, Merck KGaA announced a partnership with EOS’ sister company AMCM to develop a GMP-compliant 3D printing process for producing tablet formulations. The goal of the collaboration is to first develop this technology for clinical trials and eventually scale it up to a full digital solution for commercial-scale production. The development is based on a customized powder bed fusion technology provided by AMCM to Merck’s Innovation Center at its headquarters in Darmstadt, Germany. While the partners have not issued a public update on their collaboration, Merck is also reportedly exploring the potential of other 3D printing technologies for drugs, and has also partnered with the next company on our list, Triastek.

Triastek

Chinese company Triastek is also a pioneer of 3D printed medication. Founded in 2015, the company developed its proprietary Melt Extrusion Deposition (MED) 3D printing technology for pharmaceuticals. The process uses a feedstock made from an API-containing powdered raw material mixed into a “movable semi-solid”, which is then softened and extruded into oral tablets with structures tailored to specific release profiles. In January 2024, Triastek received approval from the US FDA to proceed with the IND of T22, a 3D printed gastric retention product. This takes Triastek’s total number of 3D printed drug products in the clinical development stage to four, which reportedly makes it “first in the global 3D printed drug field in terms of development product count.” The news of the FDA go-ahead followed a recent Pre-C financing round, in which Triastek raised $20.4 million, as well as the success of a first-human-trial for its T21 treatment for ulcerative colitis. Triastek has also entered into partnerships with larger pharmaceutical companies, the likes of Eli Lilly, Merck KGaA, Boehringer Ingelheim, Siemens, and Sperogenix.

This article was originally published in VoxelMatters’ VM Focus Medical eBook. Read or download the full eBook for free at this link.

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Tess Boissonneault

Tess Boissonneault is a Montreal-based content writer and editor with five years of experience covering the additive manufacturing world. She has a particular interest in amplifying the voices of women working within the industry and is an avid follower of the ever-evolving AM sector. Tess holds a master's degree in Media Studies from the University of Amsterdam.

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