Resilience Through Innovation: Aprecia’s Role in Strengthening the U.S. Drug Supply Chain

Press, Resources | November 11, 2025

As the industry grapples with tariff pressures and the need to reduce reliance on global supply chains, Aprecia’s pioneering use of 3D printing enables scalable, distributed manufacturing, making domestic production not only feasible but sustainable.

PHARMA MATTERS Q&A, October 23, 2025 – With supply chain headaches and a growing demand for personalized medicine, drug makers are under pressure to rethink how—and where—medications are made. Aprecia thinks it has the answer: commercial-scale 3D printing. In this Q&A, Kyle Smith, president and COO at Aprecia, breaks down how the company’s tech is speeding up development, enabling on-demand production, and keeping manufacturing closer to home. Aprecia already has the first FDA-approved 3D-printed drug on the market, and it’s betting that’s just the beginning.

Smith talks about how distributed manufacturing could help reduce reliance on overseas production, boost sustainability, and make medicines more patient-friendly. He also shares how Aprecia is working with regulators, expanding its IP footprint, and partnering with pharma companies ready to take 3D printing from concept to commercial reality..

Contract Pharma: How does Aprecia view its role in strengthening the resilience of the U.S. drug supply chain, particularly as the industry looks to reduce dependence on global suppliers?

Kyle Smith: Aprecia views its role in fortifying the U.S. drug supply chain as both urgent and transformative. With over two decades of leadership in pharmaceutical additive manufacturing, Aprecia has pioneered 3D printing as a scalable, reliable and patient-centric solution for drug production. As global supply chain vulnerabilities continue to challenge the industry, Aprecia offers a domestically anchored alternative that enhances agility and reduces reliance on offshore manufacturing.

The company’s advanced technologies emphasize speed, flexibility, and precision, establishing new benchmarks for dependable medication production and distribution in the U.S. Through partnerships with pharmaceutical companies, Aprecia enables faster go/no-go decisions in clinical trials, lowers investment risk, and improves responsiveness to protocol changes—all while keeping development and manufacturing within the U.S.

CP: What advantages do Aprecia’s 3D printing platform offer compared to traditional manufacturing when it comes to scalability, flexibility, and speed-to-market?

Kyle: Aprecia’s state-of-the-art 3D printing technologies prioritize speed, flexibility, and precision, setting new standards for reliable pharmaceutical manufacturing and distribution. Unlike traditional centralized production models, which often require lengthy and iterative development programs with multiple scale-up operations, Aprecia’s 3D printing platforms enable scalable and localized production.

Aprecia’s advanced platforms enable complex tablet structures, providing freedom and flexibility to design novel dosage formulations that address unmet patient needs. These include:

• Complex tablet structures: Aprecia’s technology enables the manufacturing of tablets with varying degrees of hardness and mechanical strength, allowing for the creation of novel dosage formulations that incorporate embedded functionalities.

• Administrative solutions: The platform produces tablet structures that dissolve effortlessly in a patient’s mouth with just a sip of water, improving ease of administration and patient compliance.

• Customizable medications: Aprecia supports the production of highly customizable, patient-specific medications with precise dosing, offering both cost and logistical advantages for pharmaceutical partners.

• Flexible administration: The system provides flexible oral administration options and dosage forms, including embedded features for taste masking and enhanced bioavailability, while maintaining broad API compatibility to meet diverse dosing needs.

Aprecia is setting a new benchmark for pharmaceutical innovation by combining speed, flexibility, and precision in commercial-scale 3D printing. Our platforms streamline formulation timelines, support real-time batch release, and enable the rapid development of complex, patient-friendly dosage forms. By producing entirely in the U.S., we’re not only addressing supply chain vulnerabilities, but also empowering pharmaceutical partners with on-demand, distributed manufacturing capabilities that unlock personalized medicine and accelerated clinical success.

Contract Pharma: With tariff pressures and geopolitical uncertainties challenging global supply chains, how can Aprecia’s distributed manufacturing model help mitigate these risks?

Kyle: Our innovative approach to pharmaceutical manufacturing supports efforts to maximize and streamline capabilities in the U.S. in two ways. First, it enables us to create unique products that conventional technologies can’t—like SPRITAM®, the first FDA approved 3D-printed prescription medication, and a range of other dosage forms from orally disintegrating tablets to extended-release and suspensions. Second, our model supports distributed and flexible manufacturing, which opens the door to onshoring, on-demand production, and personalized medicine. We’ve shown that 3D printing isn’t just for prototyping—it’s a viable commercial manufacturing solution.

CP: Beyond supply chain resilience, what sustainability benefits does 3D printing bring to pharmaceutical manufacturing and domestic production?

Kyle: Distributed manufacturing not only strengthens supply chain resilience; it also delivers significant, additional sustainability advantages. By enabling decentralized production, 3D printing dramatically reduces transportation emissions and packaging waste. Manufacturing closer to the point of care or distribution allows Aprecia to minimize the carbon footprint traditionally associated with global pharmaceutical supply chains, while supporting faster, more localized responses to patient needs. Benefits include:

• On-demand production: Further enhances sustainability by reducing overproduction and excess inventory. This lean approach aligns with environmental goals and modern manufacturing principles, helping companies avoid waste and optimize resource use.

• Energy efficiency and material optimization: Unlike traditional manufacturing methods, 3D printing uses only the material needed for each product, minimizing waste. It also allows for precise control over dosage forms, reducing the need for excess raw materials and energy-intensive processes.

• Localized manufacturing supports domestic resilience: Aprecia’s U.S.-based facilities and participation in government-funded initiatives demonstrate how 3D printing can strengthen domestic pharmaceutical production, reducing reliance on overseas manufacturing and supporting local economies.

• Customization reduces overproduction: By enabling personalized medicine, 3D printing avoids the inefficiencies of mass production. Tailored dosage forms mean fewer unused or discarded medications, contributing to more sustainable and patient-centered healthcare delivery.

CP: How can Aprecia work with pharma and biopharma partners to implement distributed manufacturing models, and what kinds of projects best demonstrate these collaborations?

Kyle: Today, Aprecia is collaborating in a U.S. government funded research program to investigate ways to enable us to contribute toward public health initiatives while facilitating broader adoption of advanced manufacturing technologies and Pharma 4.0 infrastructure.

At Aprecia, we believe partnerships are essential for solving medication design challenges and advancing product development across different therapeutic categories. We collaborate with innovative researchers, manufacturers, and technology companies throughout the pharmaceutical life cycle to enhance the value of our technologies. Through collaboration, we support companies seeking to create novel dosage forms, all while accelerating time to market and reducing environmental impact.

In 2015, Aprecia made history with the FDA approval of SPRITAM. This milestone validated 3D printing as a viable pharmaceutical manufacturing method and opened the door for broader regulatory acceptance.

Since then, Aprecia has secured over 126 patents and continues to collaborate with regulatory bodies to advance agile manufacturing standards. Aprecia’s work to date demonstrates a commitment to meeting regulatory requirements, while also shaping and redefining them.

CP: What are the biggest regulatory considerations for scaling 3D-printed drug products, and how is Aprecia collaborating with agencies to ensure compliance and adoption?

Kyle: Scaling 3D-printed drug products involves navigating regulatory challenges, including material consistency, process control, analytical validation, and quality assurance. Because additive manufacturing introduces novel variables, regulatory agencies require robust data to ensure safety, efficacy, and compliance with Good Manufacturing Practices (GMP). Aprecia has real world, in-market experience, showcasing its expertise in achieving this with SPRITAM’s FDA approval in 2015.

Aprecia addresses these challenges through its comprehensive CMC support incorporating quality by design, guiding partners from development through commercialization. This includes:

• Raw material selection and testing

• Analytical method development and validation

• Stability and physicochemical testing

• Scalable manufacturing practices

• Stringent quality control protocols

To support regulatory adoption of a new drug, Aprecia collaborates with federal agencies to generate the scientific evidence needed to validate 3D-printed pharmaceuticals. These efforts aim to align innovative manufacturing technologies with evolving regulatory standards, paving the way for broader industry acceptance and point-of-need production capabilities.

CP: Looking ahead, where do you see the greatest opportunities for 3D printing to transform not only supply chain resilience but also patient access and personalization in medicine?

Kyle: At Aprecia, we see the future of 3D printing as a powerful convergence of supply chain agility, precision drug delivery, and personalized medicine. Aprecia’s 3D printing platforms allow for layer-by-layer control of dosage forms, enabling tailored therapies for specific patient needs, including high-potency, modified-release, and orally disintegrating tablets. These capabilities are especially impactful for populations with swallowing difficulties, rare diseases, or complex dosing regimens.

Aprecia’s technology also addresses common barriers to medication adherence. Tablets that dissolve effortlessly may improve ease of administration, especially for patients with dysphagia or those requiring high-dose therapies. Customizable dosing to each patient’s precise need may contribute to overall better outcomes, including reduced pill burden and side effects.

The ability to embed functionalities, such as taste masking, controlled release, and multi-API combinations, within a single tablet also offers pharmaceutical companies new avenues for innovation.

Aprecia believes 3D printing is not just a manufacturing innovation. It is a transformational tool for delivering flexible, patient-centric therapies while building a more resilient and responsive pharmaceutical supply chain.

CP: In a crowded CDMO and technology landscape, what differentiates Aprecia as a partner for companies that want to strengthen their supply chains and bring innovative products to market?

Kyle: Aprecia is the only advanced additive manufacturer with an FDA-approved, 3D printed product and commercial-scale capabilities.

With a focus on oral solid dose medications, combined with deep expertise in formulation science and regulatory strategy, Aprecia is a category leader. Competitors may offer prototyping tools or niche applications, but Aprecia’s end-to-end platform—from development to distribution—sets it apart.

As we look ahead, Aprecia’s commitment to innovation, speed, and precision positions it at the forefront of pharmaceutical transformation. Its platforms enable flexible, localized production models that support onshoring, personalized therapies, and rapid response to emerging health needs.

3D printing is no longer a future promise—it’s a present-day solution. At Aprecia, we’ve proven that additive manufacturing can deliver scalable, patient-centric therapies with speed, precision, and resilience. Our platforms are built not just to meet today’s challenges, but to redefine what’s possible in medicine tomorrow.

By combining advanced 3D printing with strategic partnerships and regulatory leadership, Aprecia is not just changing how medicine is made—it’s changing what’s possible.

For more information on Aprecia’s role in pharmaceutical resilience reach out to our experts at [email protected]