The pharmaceutical industry is witnessing a transformative shift as 3D printing technology emerges as a powerful tool for drug delivery innovation, offering unprecedented precision, personalization, and efficiency in medication manufacturing.
Precision Medicine Through Micro 3D Printing
Researchers at City of Hope Cancer Center Duarte have developed a groundbreaking approach to liver cancer treatment using micro 3D printing technology. The team designed an innovative intratumoral catheter inspired by bee stingers, featuring 0.4-millimeter holes and finely detailed barbs that traditional manufacturing methods could not produce with sufficient precision.
"Traditional manufacturing methods, and even standard 3D printing technologies like stereolithography, couldn't meet the precision needed for these ultra-small and intricate design features," explained researchers involved in the project.
Using Projection Micro Stereolithography (PµSL) technology, the team successfully fabricated the complex catheter structure with micro-sized barbs, sideholds, and a central channel. Early testing demonstrated remarkable results, with the barbed sidehold catheter achieving 183-fold higher localized drug concentrations compared to standard intravenous injection methods.
John Kawola, CEO of Boston Micro Fabrication, notes: "Micro 3D printing has a unique ability to produce parts with tight tolerances where precision, accuracy, and ultra-high resolution are required. What's more is that micro 3D printing offers a cost-effective solution for patient-specific solutions."
Transforming Pharmacy Compounding
In early 2025, the world's first study implementing pharmaceutical 3D printing for compounding and dispensing medications directly in a retail pharmacy was published. The study focused on minoxidil, commonly used to treat various types of hair loss, which is frequently compounded in low-dose oral solid formulations.
Working under applicable compounding guidelines, researchers used semi-solid extrusion (SSE) 3D printing technology available in the M3DIMAKER 1 3D printer to automatically fill capsules in two dose strengths at a community pharmacy in Madrid. The results were compared with traditional compounding procedures for the same strengths of minoxidil capsules.
The study revealed significant advantages of the 3D printing approach:
- 55% reduction in pharmacist involvement time
- Lower margin for human-induced errors
- Automated mass uniformity assurance through integrated analytical balance and pressure sensors
- Real-time process monitoring with exact identification of out-of-specifications dosage units
Both conventional and 3D printer-compounded capsules met applicable mass uniformity specifications, but the partially automated process substantially reduced overall manufacturing time while maintaining quality standards.
Clinical Applications in Hospital Settings
The Institut Gustave Roussy, Europe's leading cancer research hospital in Paris, has implemented capsule filling via SSE attachment in the pharmaceutical 3D printer M3DIMAKER 2 within their hospital pharmacy. Their goal was to develop a process for manufacturing personalized pharmaceutical interventions for a clinical trial involving 200 cancer patients.
The team of pharmacists demonstrated impressive efficiency, manufacturing 200 multi-drug capsules in just 45 minutes, including time for pharma-ink manufacture and offline quality control. This manufacturing time could be further reduced if pharma-inks were supplied directly to the hospital pharmacy from licensed manufacturers and through the integration of in-line quality control systems.
"The pharmaceutical 3D printers are also now used routinely to produce 'traditional,' layer-by-layer 3D-printed medicines in the hospital pharmacy under existing compounding regulations, to treat cancer patients through more tailored medications," according to a press release from Gustave Roussy in February 2025.
Regulatory Frameworks for Distributed Manufacturing
The potential of 3D printing extends beyond individual healthcare facilities to distributed manufacturing models. In this paradigm, multiple distributed 3D printing manufacturing sites would be enabled by centralized pharmaceutical quality system (PQS) sites, similar to hub-and-spoke models.
New legislation coming into effect in summer 2025 in the United Kingdom recognizes distributed manufacturing of medications through 3D printing, termed "modular manufacture." This framework includes oversight of production activities at self-contained modular manufacturing units by a centralized control site.
Similar frameworks are under development by the FDA and the European Medicines Agency, expected to follow in the near future. Once finalized, these frameworks will officially mark the beginning of a new dimension for pharmaceutical manufacturing and personalized medications within their respective regulatory realms.
Future Implications
The applications of 3D printing in pharmaceuticals extend beyond Earth. NASA is exploring the technology to tackle future medical therapy in outer space, recognizing its potential for on-demand medication production in remote environments.
For pharmaceutical companies, 3D printing offers significant implications for early-stage development and first-in-human studies. The technology enables rapid prototyping and production of small batches for clinical trials, potentially accelerating the drug development process.
As Anna Kirstine Jørgensen, a PhD student in the Department of Pharmaceutics at UCL School of Pharmacy, and colleagues note, "3D printing of drug products was once only seen as an alternative manufacturing technology for conventional large-scale manufacture. However, persistent efforts have more recently proven its applicability in producing small batches of tailored medicines."
Technological Considerations
Several 3D printing technologies are currently applicable in clinical settings, including semi-solid extrusion (SSE), fused deposition modeling (also known as fused filament fabrication), and direct powder extrusion. These methods utilize FDA-approved, generally recognized as safe excipients already available in good manufacturing practice (GMP) grades.
The continuous advancements in design, functionalities, and software of pharmaceutical 3D printers enable partially automated manufacturing processes with enhanced quality control. This flexibility allows for various implementation strategies, some of which are already realistically attained under current and emerging drug manufacturing paradigms.
As the technology continues to evolve, 3D printing is poised to play an increasingly important role in addressing healthcare's most pressing challenges, offering precision, personalization, and efficiency in medication delivery that traditional manufacturing methods cannot match.
