Triastek Opens World's Largest 3D-Printed Pharmaceutical Facility in China, Targets 300 Million Tablets Annually
核心洞察
Triastek (搜索) has established the world's largest commercial 3D-printed pharmaceutical production facility in Nanjing, capable of producing up to 300 million tablets annually once operational.
The company received China's first pharmaceutical production license for 3D-printed drugs from Jiangsu Medical Products Administration (搜索), making it only the second company globally to commercialize this technology after US-based Aprecia (搜索).
Triastek (搜索)'s lead 3D-printed drug, anticoagulant Apixaban tablet (T20j), has completed clinical trials with a marketing application planned for September 2024.
Chinese pharmaceutical company Triastek (搜索) has opened the world's largest commercial 3D-printed pharmaceutical production facility in Nanjing, Jiangsu province, marking a significant milestone in advanced drug manufacturing technology. The facility is expected to produce up to 300 million tablets annually once fully operational.
Revolutionary Manufacturing Technology
The Triastek (搜索) facility in Jiangning high-tech zone represents a departure from traditional pharmaceutical manufacturing. Instead of conventional assembly lines, the facility features fully automated, autonomous, digital precision 3D-printing devices that operate like paintbrushes on a three-dimensional canvas, applying more than 100,000 monitoring points to layer drug materials into pre-designed structures.
Traditional tablet production involves a complex five-step 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 streamlined approach offers significant advantages in structural design, production efficiency, cost, and quality control, according to Deng Feihuang, vice-president of technology at Triastek (搜索).
Enhanced Drug Design Capabilities
The 3D printing technology enables the creation of tablets with complex internal structures that are impossible to achieve with traditional manufacturing methods. Unlike conventional tablets, which are solid blocks or have simple layers, 3D printing allows for sophisticated architectural designs within the drug matrix.
These printed tablets 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 therapeutic effects.
Regulatory Milestone and Market Position
Jiangsu Medical Products Administration (搜索) recently granted Triastek (搜索) the country's first pharmaceutical production license for 3D-printed drugs. This achievement positions China as only the second country globally to commercialize 3D-printed pharmaceutical technology, following US company Aprecia (搜索).
The regulatory approval represents a major milestone for China's 3D printing pharmaceutical technology sector and demonstrates the country's growing capabilities in advanced drug manufacturing.
Clinical Pipeline and Commercial Plans
Triastek (搜索)'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 (搜索)'s Center for Drug Evaluation in September for market approval.
Beyond its lead product, Triastek (搜索) has more than 10 3D-printed drug products currently in phase I or phase II clinical trials, including both large and small molecule drugs. The company is also constructing a second 3D-printed drug production line specifically for hormone drugs, which is expected to be completed by December this year along with the second phase of its production base.
Manufacturing Advantages
The 3D printing approach offers several key advantages over traditional pharmaceutical processes. The drug production process is digitally controlled, ensuring precise traceability of each tablet's quality. Perhaps most significantly, the development cycle is dramatically shortened from what once took years to just a few months.
Infrastructure Support
The success of Triastek (搜索)'s facility has been supported by comprehensive infrastructure development in the Jiangning high-tech zone. Multiple service institutions, including the Nanjing branch of Jiangsu Medical Products Administration (搜索)'s Review and Inspection Center and the Nanjing Institute for Food and Drug Control, have established facilities in the 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. "Behind the efficient service is the coordinated effort and support from multiple levels of provincial, municipal and Jiangning high-tech zone departments," Deng noted.