The next wave of personalisation: 3D printing medicines - Part 1
3D printing of medications has the potential to radically change the development of new and existing therapies, with significant patient benefits and opportunities for drug developers. In this article (first of two parts), we hear from additive manufacturing industry expert Joris Peels about the latest developments, the core technologies in use and their applications. In the second part we will continue to hear from Peels and review the ways in which medications can be modified through 3D printing, the main challenges to operating at scale and finally what should drug developers do to capitalise on this innovation.
3D printing expert Joris Peels
Peels is the Executive Editor for 3DPrint.com, a leading news service covering up to date analysis and global industry data. He is also Vice President of Consulting for Additive Manufacturing Research, where he provides advice to companies using 3D printers as well as manufacturers of these devices. On top of this he performs due diligence, strategic research and business development advice. For Peels, what makes this an exciting area is the speed with which it is changing and the intense level of competition.
A technology being used in multiple sectors
Despite being a small market of $15B, the sector has seen growth of approximately 30% per year. It has a broad range of applications from aerospace to food and healthcare. In many cases the challenges in driving adoption and scale are common across these different sectors. However, differences arise due to the degree of regulation in the sector, as well as volume and cost dynamics associated with production. Peels illustrates with an example, by comparing the differences between making a single part for a one-off satellite, to mass producing components for a car production line that would be exported across the globe. Cost and quality trade-offs are different depending upon what you are looking to produce.
Adoption of 3D printing technologies in medicine has grown relatively slowly for a variety of reasons (discussed in part 2). The first and only marketed 3D printed medicine is SPRITAM (levetiracetam) which was approved by FDA in 2015. Other 3D printed medicines are currently being developed, such as those by Triastek.
3D Printing of Pills: core printing technologies
A range of printing technologies can be used to print medications, the choice of which affects what can be produced and to what scale:
- Inkjet: This involves depositing layers of liquid/semi-liquid components that include the active pharmaceutical ingredient(s) (API) to form the pill. This approach is good at mixing different materials and compounds and could for example create drug combination pills. This technology is also ideal for printing at scale, and therefore well suited for industrial processes. SPRITAM for example is manufactured using this approach. Furthermore, viscous liquids are starting to be used which result in stronger and safer compounds. The downside to this printing technology according to Peels is that this is the most capital-intensive approach, requiring more investment and expertise to get started.
“If you want to bring a new medicine on the market, I think Inkjet is the most viable technology at the moment.”
- Material extrusion: This involves using for example a filament of the active ingredient that is heated and then used in the printing process. This is generally a very low-cost, accessible technology, however heating may cause problems with the API and quality can be limited. The approach is ideal for a research environment or for nutritional applications where low volume printing is required.
- Vat polymerisation: This uses light/ultraviolet light to produce objects with a certain surface or structure. Currently these technologies are still under development as some products created by this method have been known to pose risk to humans. However, the hope is that these problems will be addressed soon.
Where 3D printing of medicines makes sense
Standard manufacturing of medicines usually involves mass production of drugs at specified doses, providing a ‘one size fits all’ approach for patients. With benefits from economies of scale and continuous innovation, this enables drug manufacturers to lower costs.
3D printing is unlikely to be able to compete on cost with standard manufacturing approaches due to lower scale production. Therefore, its value must come from either reducing costs for specific groups of patients or by delivering better patient outcomes. According to Peels there are several viable use-cases driven by different types of personalization:
- Mass-personalization: printing of medicines for specific patient sub-populations, such as the elderly, children or babies by designing pills that are easier to swallow, better release kinetics etc. In this case, it isn’t necessary to have infinite amounts of variation to suit individuals, but rather tailor options to specific patient needs that can’t be achieved easily with standard approaches. This approach is likely to be more “regulator-friendly” given the complexities in approving drugs that have a very wide range of variable parameters e.g., personalised doses.
“We think 3-D Printing for mass-personalisation is a very logical approach from a manufacturing, regulatory and safety perspective”
- Unique-personalisation: in this case local or specialist hospital pharmacies prepare medications that are specific to individual patients. This would support existing compounding tasks already conducted in these settings. Examples could be rare or complex medical conditions or providing a variable treatment regimen according to a patient’s state as determined by specific biomarkers. Private healthcare / out of pocket markets in developed countries may be particularly interested in this option as a means of offering bespoke care.
Other key applications highlighted by Peels include:
- Pre-clinical / early-stage clinical trials: this could provide a highly cost-effective manufacturing solution in this stage to reduce cycle times and permit the drug sponsor to investigate dosing and administration options more rapidly e.g., in adaptive trials
- Drug-emitting devices: printing personalised implants for example that can secrete medicines e.g., stents
- Urgent public health situations: where a local response is required and supply of medication is difficult e.g., epidemics, disease outbreaks
Why does personalisation matter?
According to various studies, 30-60% of patients are not adherent to their treatment plans. Patients may decide to stop taking their medicines due to lack of efficacy, toxicity / side effects associated with inappropriate doses, difficulty of administration etc. 3D printing of medicines may be able to tackle some of these issues by producing drugs that meet the needs of patients better. In doing so, it is expected patient outcomes will improve.
As we will see in the next article, there are many additional ways in which medicines can be personalised with 3D printing. For now, we can already see opportunities for health systems working with pharmaceutical companies to unlock new ways of treating patients.
“100% of drug development companies should be looking at this. The cost savings are there, and they can treat patients that normally wouldn’t be treated”
For this reason, Peels recommends that all pharma and biotech companies should investigate options for 3D printing. This is because a compelling health economic case exists, which can deliver better outcomes for a wider group of patients.