On the first day of the conference, Xialong Li, PhD and Jae Yoo, PhD discussed the history of 3D printing in the pharmaceutical industry and applications that they are researching or currently using in drug development. Li is CSO of Triastek and a professor/associate dean at the University of the Pacific. Yoo is chief technology officer of Aprecia Pharmaceuticals. These experts guided discussion of advances in 3D printing technology and applications in the biosciences.
3D printing for the pharmaceutical industry
3D printing has been around since the 1980’s, however it’s first application for the pharmaceutical industry did not occur until 1996. This technology was developed by Michael Cima at the Massachusetts Institutes of Technology (MIT). After this, advances were slow due to the difficulty in optimizing the equipment for use with biologics, which remains a struggle today.
There are several varieties of 3D printing machines, all with positives and negatives when it comes to working with biologics. FDM (fused deposition modeling) has been a particularly popular style of 3D printing in the pharmaceutical industry. FDM technology has one major drawback: filament design, according to Li, which holds the active pharmaceutical ingredient (API). The formulation of the filament must be accurate and able to withstand high temperatures during printing, which is where formulators often run into trouble. He also stresses that “companies are using commercially available machine that are not suited to the needs of the pharma industry, which causes many problems because of their fixed parameters.” He believes that 3D printing can help accelerate the timeline of from manufacturing to regulatory processes, and in the development of personalized medicines.
Researchers have already identified what is required for 3D printing to be successful in the pharmaceutical industry: no chemical interactions between excipient and API, rapid processing speeds, scalable technology, excipients must be GRAS or FDA approved, and machines designed specifically for the pharmaceutical industry. Now, drug development scientists are in a race to find the optimal process.
3D printing for oral drugs
Li and his team have developed a technology called melt extrusion deposition (MED) which is a 3D printing process that involves mixing, melting, extrusion and deposition of materials on a xyz platform. This method has been tested in many drug delivery systems, including both layer and compartment designs. To prove that the technology is scalable, Triasek has built a full-scale continuous manufacturing line that runs on Siemens WinCC technology. In this manufacturing line, each tab is printed with a unique QC code which provides an individual history for EACH pill.
In 2015, Yoo and his team at Aprecia Pharmaceuticals successfully patented the first 3D printed, FDA approved drug on the market: Zipdose. This drug was developed using a powder-liquid deposition 3D printing method, called binder jetting. Since Yoo worked in Cima’s lab at MIT, this is a technology based on the first 3D printer designed for pharmaceuticals. In binder jetting, the printing powder (fluid + powder blend with API) enters a nozzle that sprays a thin layer about 250 micrometer thick on a conveyer belt and the process is repeated 20 to 30 times depending on the formulation and design. Post-processing is required for this technique with low heat drying, harvesting and de-dusting. With this technology Aprecia hopes to achieve additional formulations at ultra-low doses, zero order release profile, and complex release profiles. Aprecia has scaled up this technology for commercial use, with specially designed 3D printers.
“The FDA is really engaged” in the process of approving 3D printing pharmaceuticals, according to Yoo. He described this a part of the essential innovation process that is needed in the drug discovery and development processes.
3D printing for tissue engineering
Later in the conference, Mahima Singh, PharmD, PhD candidate at the University of the Sciences, presented her research on the use of 3D printing in tissue engineering. While drug printing is challenging, tissue engineering is considered exponentially more complicated. The process often involves printing a scaffold which can hold cells, followed by placing cells in the scaffold and then placing the pre-tissue into a bioreactor to stimulate growth of the cells. There are a number of techniques available to achieve this, namely: solvent cast printing, selective laser melting, and continuous digital light printing. Singh stressed the importance of software and accuracy in this process, as the tissues produced need to fulfill specific needs in the patient. Finally, the artificial tissue can be placed into the patient. Special considerations for this type of 3D printing include scaffold material, cell type (prevent the use of anti-rejection medication), and type of printer.
In just a few short years, 3D printing technology has come a long way to providing a unique benefit to the drug development field. We are excited to see what the future hold as technology advances as such a rapid pace how 3D printing can accelerate the development of life-saving therapies.
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