There has been a noticeable shift in recent years towards the personalization of medicine, with the pharmaceutical industry showing interest in pills that are tailored to a patient’s needs. Here are five companies that are leveraging 3D printing to produce customizable drugs.
Conventional drug production relies on large-scale batch manufacturing, which is very efficient at churning out large volumes of drugs with uniform characteristics. But this becomes time-consuming and expensive when small batches are needed, such as for clinical trials where the doses need to be adjusted. The process is also associated with an environmental burden resulting from inefficient use of raw materials, expired stock and production of toxic and non-toxic waste.
Additive manufacturing, or 3D printing, is a tool that can allow for small-scale production of medicines. This approach uses 3D modeling software to build an object layer-by-layer; for solid drugs, the 3D printer stacks ink with an excipient — inactive substances in drugs added for specific functions like improved stability and bioavailability — and the active pharmaceutical ingredient to print out a finished product. By adjusting the printing parameters, the drug dosages, drug combinations, release profiles and even flavors can be personalized.
There are many challenges that have limited widespread implementation of 3D printing technology, such as 3D printers not meeting good manufacturing practice standards and a limited range of excipients suitable for 3D printing. Nevertheless, 3D printing has the potential to revolutionize the pharmaceutical industry, and several companies are making strides in the space.
Aprecia Pharmaceuticals
Headquarters: Pennsylvania, U.S.
Aprecia Pharmaceuticals is behind the first and only U.S. Food and Drug Administration (FDA)-validated 3D printing platform for commercial-scale drug development. Their aim is to make medicines easier to take and reduce the number of pills a patient needs. Using this platform, Aprecia developed ZipDose Technology, which allows tablets to hold a high dosage load of up to 1,000 mg and still rapidly dissolve with just a sip of water.
ZipDose is used in the production of Spritam (levetiracetam), a fast dissolving oral medicine for the treatment of specific types of epileptic seizures. It is targeted for patients who struggle to swallow pills or are unable to measure out the precise dosage of liquid levetiracetam. In 2015, Spritam became the first and only 3D printed drug to be approved by the FDA.
FabRx
Headquarters: London, U.K.
Founded in 2014 as a spin-out of University College London, FabRx aims to revolutionize medical treatments by facilitating the production of personalized medicines, where the size, shape, dosage and dosage combinations can be customized. In 2020, the company released M3DIMAKER, the first pharmaceutical 3D printer for personalized medicine, allowing clinicians and other professionals to “print” tailored medicines on demand.
Using their 3D printing technology, FabRx has also created a range of personalized Printlets — medicines with customized shapes, flavors, colors, dosages and release profiles, such as tablets with Braille and moon patterns for patients with visual impairments as well as Polypills, which combine several drugs in one pill.
FabRx technology is also being used to print personalized pills for children with a rare metabolic disorder called maple syrup urine disease, which requires treatments to be strictly tailored based on age, weight and blood concentrations of the amino acid isoleucine. Current manual preparation methods are time consuming and costly, so FabRx’s approach could save time and money for caregivers.
Merck
Headquarters: Darmstadt, Germany
The biopharma giant Merck is also taking a stab at next-generation tablet manufacturing through 3D printing. In 2020, Merck announced a cooperation with ACMC — sister company of EOS, a worldwide provider of 3D printing solutions — to produce 3D printed tablets for clinical trials at first, before moving towards commercial-scale manufacturing. This partnership aims to advance the industrial applications of 3D printing technology and digitalization.
Triastek, Inc.
Headquarters: Nanjing, China
Triastek is a global leader in pharmaceutical 3D printing, with 41 patents that account for more than 20% of global 3D printing pharmaceuticals applications. Using their proprietary MED 3D printing technology, Triastek develops their own in-house drugs and partners with others to provide drug development solutions.
The MED 3D printing platform allows for the customizable design of tablets, with the different shapes and geometries controlling drug onset time, duration, and drug interactions with the body. This platform was accepted into the FDA’s Emerging Technology Program in 2020, and two of their 3D printed drugs have been granted investigational new drug clearances from the FDA. The first is a chronotherapeutic drug for rheumatoid arthritis, where the drug is taken at bedtime but its release is delayed until the early morning hours, when pain and joint stiffness are at their peak. The second is a one-dose pill alternative to the twice-daily marketed drug for cardiovascular and clotting disorders.
Triastek recently entered into a research collaboration with Eli Lilly and Company to improve the bioavailability of drugs in the intestine by achieving precise organ targeting and programmed drug release.
GlaxoSmithKline
Headquarters: Brentford, U.K.
GSK was one of the first big pharma companies to show interest in 3D printing as a manufacturing tool, partnering with the University of Nottingham to study the feasibility of 3D inkjet printing and curing with ultraviolet light to produce solid drug forms; in 2017, researchers demonstrated the successful 3D printing of ropinirole tablets for Parkinson’s disease.
3D inkjet printing deposits liquid materials or solid suspensions layer-by-layer but each deposited layer must first be dried, or “cured,” between the deposition steps. GSK is exploring how to convert active pharmaceutical ingredients into curable ink to enable 3D drug printing.