A Game Changer?

EPM takes a look at a technology coming out of China receiving international acclaim and regulatory approval and ponders if 3D printing can finally make the leap it has been promising for the best part of two decades.

In the bustling world of pharmaceutical manufacturing, whispers of a game-changer are getting louder. Triastek, Inc., a pharmaceutical brainchild from China, is the trailblazer behind an innovative 3D printing technology that's causing a stir within the industry. The implications of this technology, laced with the company's ambitious vision, signals a potentially radical shift for pharmaceutical manufacturing. This shift promises not just enhancements to production efficiency, but also provides fresh solutions to complex drug delivery conundrums.

Nestled in Nanjing, China, Triastek is already turning heads on the international stage, bagging recognition from heavyweights like J.P. Morgan, which included the company in its illustrious list of Top 100 Women-Powered, High-Growth Businesses in the Asia Pacific.

Recently the organisation announced a collaboration with Siemens Ltd., China, which brings together a pioneering 3D printing technology and a wealth of automation and digitisation expertise. This partnership is a calculated attempt to accelerate the digital transformation of the pharmaceutical industry. While the concept of digital transformation is not new, the full extent of its impact on the pharmaceutical industry is yet to be realised. As Mr. Jinsong Zhang, Senior Vice President and General Manager of sales region east of digital industries of Siemens Ltd., China, acknowledged in the accompanying press release, "Siemens' strategic cooperation with Triastek builds a win-win cooperation of a digital solution provider leader and a 3D printing pharmaceutical leader."

The future of Pharmaceutical Manufacturing?

At the centre of this collaboration is Triastek's proprietary MED (Melt Extrusion Deposition) 3D printing technology. This technology uses a solvent-free process that eliminates the need for drying, thereby reducing production time and potentially increasing manufacturing efficiencies. It also allows for greater flexibility in the use of excipients, expanding the range of materials that can be used in the 3D printing process. This presents a significant departure from the conventional pharmaceutical manufacturing processes.

Triastek's MED technology is also allowing the company to create complex drug structures and formulations, overcoming limitations of traditional extended-release product development. This technology could open up new avenues in the development and manufacturing of solid dosage forms.

Triastek has already developed a commercial-scale MED 3D printing system, the world's first continuous manufacturing line for 3D printing pharmaceuticals. With a production rate of approximately 50 million tablets per year, it marks a significant milestone, testifying to Triastek's determination to realise its vision.

International acclaim

Moreover, Triastek's 3D printed medicine, T21, represents an exciting potential use of this technology for targeted drug delivery. Designed for the treatment of ulcerative colitis, T21 aims to achieve colon-targeted drug delivery. This innovative application of MED technology could allow for lower drug doses compared to reference listed drugs, thereby minimising potential side effects.

Triastek's innovative spirit, as embodied in its MED technology, has not gone unnoticed. The company's nomination as a finalist in the TCT Awards 2023 for Healthcare Applications, hosted by the same company that runs the European Pharmaceutical Manufacturing (EPM) magazine, recognises the potential of Triastek's technology to disrupt the status quo in pharmaceutical manufacturing. One of the TCT Awards’ expert judging panel noted:“It is great to see this concept coming to fruition as it has been talked about for many years. The productivity of this process along with the use of FDA-approved materials is very impressive.”

Overcoming Regulatory Hurdles

Despite these promising advancements, the journey towards a digitally transformed future in pharmaceutical manufacturing is a challenging one, fraught with technical and regulatory hurdles. There's no question that the regulatory hurdles for any pharmaceutical innovation are colossal, and it's worth noting that Triastek has already made substantial progress in this area.

In April 2022, Triastek announced that the US Food and Drug Administration (FDA) had granted Triastek permission to begin clinical studies of its Investigational New Drug (IND) 505(b)(2) application for a 3D printed drug product – T20. This approval marks Triastek's second product to receive IND clearance from the FDA.

The importance of this clearance cannot be overstated. T20 is a once-daily formulation developed using Triastek's innovative digital formulation development process and programmed drug release technology. Its application is significant; it's intended for the treatment of cardiovascular and clotting disorders and promises to improve patient adherence by reducing the current twice-daily dosage to just once a day. The potential improvement in patient outcomes is a powerful demonstration of the real-world impact of Triastek's technology.

Triastek's Melt Extrusion Deposition (MED) 3D printing technology was instrumental in the development of T20. The company's 3D printing formulation by design (3DFbD) method begins with the desired extended release pharmacokinetic profile, informing the formulation development with a physiologically-based biopharmaceutical model (PBBM) of gastrointestinal tract (GIT) absorption. This novel process overcomes many limitations of traditional extended release product development and manufacturing, as demonstrated in animal studies using a prototype formulation of T20.

The FDA IND clearance of T20 is more than just a regulatory milestone. As Dr. Senping Cheng, founder and CEO of Triastek, noted at the time, "The FDA IND clearance of T20 is a significant milestone for Triastek, and demonstrates the significant progress in 3D printing pharmaceuticals." These are not mere words; they encapsulate the journey of an emerging technology that has been explored for over 26 years, now nearing its maturity with the potential to make a real difference in the pharmaceutical industry.

Triastek is not just about creating innovative technologies; it's about applying these technologies to develop its own product pipeline, as well as co-developing products with multinational and Chinese pharmaceutical companies. The focus is on blockbuster small molecule drugs, demonstrating the utility of Triastek's novel pharmaceutical product development technology and continuous GMP manufacturing capabilities.

As we look towards the upcoming TCT Awards in June 2023, where Triastek's innovation in pharmaceutical manufacturing has been recognised with a nomination, it's evident that the pharmaceutical industry is on the cusp of a digital revolution. Triastek, with its pioneering technology and unwavering dedication to overcoming regulatory and technological challenges, is at the forefront of this exciting transformation.

Triastek's innovative spirit and the potential of its MED technology to disrupt the status quo have certainly caught the industry's attention. The company's potential to revolutionise the industry is clear, but its success will ultimately be determined by its ability to bring its innovative technology to the market and integrate it into existing pharmaceutical manufacturing processes.

Navigating the Challenges

The road to realising this new digital pharmaceutical future is undeniably a steep one. The challenges are multifaceted and range from technological to regulatory. The implementation of the MED technology on a larger scale will undoubtedly require rigorous testing, ongoing research and development, and constant iteration. It will also require a careful navigation of the regulatory landscapes, which can often be complex and time-consuming.

However, the recognition of Triastek's innovative approach by experts on judging panels and the approvals from the FDA signals a favourable industry response. The TCT Awards nomination is not just an endorsement of Triastek's innovative technology; it also acknowledges the potential of this technology to address the challenges of traditional pharmaceutical manufacturing.

With its innovative manufacturing technology, its partnerships and its drive to push boundaries, Triastek the potential to play a significant role in shaping the future of pharmaceutical manufacturing.