Charles R. Goulding and Preeti Sulibhavi examine how 3D printing and domestic production strategies are revolutionizing drug manufacturing and paving the way for a resilient, patient-centered pharmaceutical future.
The COVID-19 pandemic exposed critical vulnerabilities in the global pharmaceutical supply chain, prompting a reevaluation of drug manufacturing strategies. In response, initiatives have emerged to bolster domestic production and explore innovative technologies like 3D printing to ensure a resilient and personalized healthcare system.
The Imperative for Domestic Drug Manufacturing
The pandemic underscored the risks associated with reliance on foreign-made critical drugs. Disruptions in international supply chains led to shortages, emphasizing the need for a robust domestic pharmaceutical infrastructure. However, establishing new pharmaceutical facilities is a time-intensive process, often spanning several years. During this transition, patients remain vulnerable to supply chain interruptions, necessitating immediate and innovative solutions to bridge the gap.
3D Printing: Revolutionizing Personalized Medicine
Three-dimensional (3D) printing, or additive manufacturing, has emerged as a transformative technology in the pharmaceutical sector. By constructing objects layer by layer based on digital models, 3D printing enables the creation of complex and customized drug formulations. This technology facilitates the production of personalized medications tailored to an individual’s genetic makeup, physiology, and specific disease profile. Integration with wearable monitoring devices and artificial intelligence can further refine treatment by allowing real-time adjustments to dosage and formulation.
Spritam: A Milestone in 3D Printed Pharmaceuticals
In 2015, the U.S. Food and Drug Administration (FDA) approved Spritam (levetiracetam), marking the first instance of a 3D printed drug receiving regulatory clearance. Developed by Aprecia Pharmaceuticals, Spritam utilizes ZipDose® Technology, enabling the production of highly porous tablets that disintegrate rapidly with a sip of liquid. This innovation addresses challenges faced by patients with swallowing difficulties, particularly those with epilepsy. Aprecia’s achievement underscores the potential of 3D printing in creating patient-centric drug delivery systems.
Advancements and Applications in 3D Printed Drug Delivery
Recent studies have highlighted the versatility of 3D printing in pharmaceutical applications. Technologies such as inkjet printing, binder jetting, fused deposition modeling, and stereolithography have been employed to fabricate dosage forms with precise control over drug release profiles and dosages. For instance, researchers have developed polypills combining multiple medications into a single tablet, enhancing patient compliance and simplifying complex treatment regimens. Additionally, 3D printing has been utilized to create dosage forms tailored to pediatric and geriatric populations, addressing specific needs related to dosage strength and administration routes.
Regulatory Considerations and Challenges
Despite the promising applications of 3D printing in personalized medicine, regulatory frameworks have yet to fully adapt to this emerging technology. The FDA’s 2017 guidance on additive manufacturing primarily addresses medical devices, leaving a gap in specific regulations for 3D printed pharmaceuticals. Challenges include establishing standards for quality control, ensuring reproducibility, and defining the scope of regulatory oversight for decentralized manufacturing processes. Addressing these issues is crucial for the widespread adoption of 3D printing in drug manufacturing.
Future Perspectives: Towards Decentralized and On-Demand Drug Production
The integration of 3D printing into pharmaceutical manufacturing holds the promise of decentralized and on-demand drug production. Concepts like the “chemputer,” a digital platform capable of synthesizing drugs from basic chemical components, envision a future where medications can be produced at the point of care or even in patients’ homes. Such advancements could democratize access to essential medications, particularly in remote or underserved regions, and enhance the responsiveness of healthcare systems to emerging health challenges.
As this article was being finalized, President Trump signed an executive order aimed at lowering drug prices for Americans by forcing drugmakers to offer their lowest prices to the US, as it does many other nations globally.
The Research & Development Tax Credit
The now permanent Research and Development (R&D) Tax Credit is available for companies developing new or improved products, processes and/or software.
3D printing can help boost a company’s R&D Tax Credits. Wages for technical employees creating, testing and revising 3D printed prototypes are typically eligible expenses toward the R&D Tax Credit. Similarly, when used as a method of improving a process, time spent integrating 3D printing hardware and software can also be an eligible R&D expense. Lastly, when used for modeling and preproduction, the costs of filaments consumed during the development process may also be recovered.
Whether it is used for creating and testing prototypes or for final production, 3D printing is a great indicator that R&D Credit-eligible activities are taking place. Companies implementing this technology at any point should consider taking advantage of R&D Tax Credits.
Conclusion
The convergence of domestic drug manufacturing initiatives and 3D printing technology represents a significant stride towards a more resilient and personalized healthcare system. By embracing these innovations, the United States can mitigate supply chain vulnerabilities, tailor treatments to individual patient needs, and pave the way for a new era in pharmaceutical care. Continued research, investment, and regulatory evolution will be pivotal in realizing the full potential of 3D printed personalized medicine.
