The world's largest commercial 3D-printed pharmaceutical production facility is taking shape in Nanjing, Jiangsu province. Once it begins operations, it is expected to produce up to 300 million tablets annually.

Upon entering Triastek's facility in Jiangning high-tech zone of Nanjing, you will find no traditional assembly lines. Instead, the facility features fully automated, autonomous, digital precision 3D-printing devices.

The devices operate like paintbrushes on a three-dimensional canvas, applying more than 100,000 monitoring points to layer drug materials into pre-designed structures to "draw" uniquely shaped tablets.

Traditional tablet production involves a complex process of granulation, mixing, tableting, coating and blister packaging. In contrast, 3D-printed drugs require only three steps: blending and melting, printing, and packaging.

This approach offers advantages in terms of structural design, production efficiency, cost, and quality control, according to Deng Feihuang, vice-president of technology at Triastek. Unlike traditional tablets, which are solid blocks or have simple layers, 3D printing allows for more complex internal structures.

Printed tablets also come with additional advancements. They can be designed to release drugs at a controlled rate, preventing fluctuations in blood drug concentration. Additionally, a "positioning system" can be incorporated to deliver the tablet precisely to different parts of the gastrointestinal tract to maximize its therapeutic effects.

Beyond these benefits, 3D printing offers further advantages over traditional pharmaceutical processes. The drug production process is digitally controlled, ensuring the precise traceability of each tablet's quality. Moreover, the development cycle is significantly shortened; what once took years can now be completed in just a few months.

Jiangsu Medical Products Administration recently granted Triastek the country's first pharmaceutical production license for 3D-printed drugs. This achievement marks a major milestone for China's 3D printing pharmaceutical technology, as it becomes the second company in the world, after US company Aprecia, to commercialize 3D-printed drugs.

Triastek's first 3D-printed drug, the anticoagulant Apixaban tablet (T20j), has completed pharmaceutical research and clinical trials. The company plans to submit a marketing application to the National Medical Products Administration's Center for Drug Evaluation in September, for market approval.

"Our company is currently constructing a second 3D-printed drug production line for hormone drugs, which we expect to complete by December this year, along with the second phase of our production base," said Deng.

Triastek also has more than 10 3D-printed drug products currently in phase I or phase II clinical trials, including large and small molecule drugs.

Multiple service institutions, including the Nanjing branch of Jiangsu Medical Products Administration's Review and Inspection Center and the Nanjing Institute for Food and Drug Control, have established facilities in Jiangning high-tech zone.

The park offers various research and pilot-scale platforms covering more than 1 million square meters, providing comprehensive technical and talent support for biopharmaceutical companies such as Triastek.

"Behind the efficient service is the coordinated effort and support from multiple levels of provincial, municipal and Jiangning high-tech zone departments," Deng said.

cangwei@chinadaily.com.cn