Frontiers in Manufacturing Science and Quality: Cutting-Edge Developments and Futuristic Products, was the third Emerging Technologies session on June 7, 2016, at the ISPE/FDA/PQRI Quality Manufacturing Conference. Moderator Sau (Larry) Lee opened the session by noting that “Emerging technology should receive as much attention as continuous manufacturing.”

Adam Procopio, Senior Principal Scientist, Merck & Co., Inc., discussed “Enabling Adaptive Drug Products via Additive Manufacturing,” the first presentation in the session.

Three-dimensional printing, also known as additive manufacturing, is a small but quickly growing part of the pharmaceutical industry. “3D printing is a revolution,” said Procopio. “Once I saw 3D printers in action, I saw the light about what they could do for drug production in the future.”

Additive technology can design a high-surface-area device that maintains the same surface area when shrunk to production size, said Procopio. This can’t be done with traditional means. “You can design something by supplying criteria and using software to build to specs,” Procopio continued. Just come up with an optimized geometry, then 3D print it. “Complexity is free in 3D printing,” he noted. “You don’t have to think about how to make it—the printer creates the complexity.”

“Three-D printing is 2D printing—several thousand times,” Procopio explained. The printers stack layers to generate parts.

Currently, there are two modes of 3D printing. Thermal phase transition—“a glorified hot glue gun”—uses laser sintering to weld polyamide particles together, or fused deposition modeling (FDM), which works with a limited set of materials, most of them not relevant to the pharma industry.

Vat photopolymerization and continuous liquid interface production (CLIP) both focus light to crosslink polymers. These processes use material jetting—“an inkejet printhead on steroids”—followed by light that turns liquids into solids. “These methods can use multiple materials,” said Procopio, “and can create parts with unique capabilities.”

“Where can pharma play in 3D printing space?” asked Procopio? “It can help in the lab to manufacture parts. It can help you work faster. You can design and use something the same day. It’s a really powerful tool.”

In 2015 FDA approved Spritam, a 3D printed oral anti-seizure drug produced by Aprecia, with a rapid dispersion and dissolution that can’t be matched with powders and a rotary tablet press. Medical devices or implants could be customized, and given to the patient faster. In the near future, for example, 3D printing could be used to create custom orthopedic implants from a radiological scan.

3D printing is already being used for tissue engineering: In 2016 Organovo and Merck entered into a multiyear research partnership for 3D-printed human liver cells. 3D printing of biological structures is on the horizon, Procopio said, with organ replacement possible within the next 20 years.

While the technology is still too slow to replace high-volume products, Procopio said, it may present opportunities for low-volume or orphan products. “It is gaining significant academic acceptance as well as industrial interest and commercial implementation due to its ability to create complex geometries along with customizable material properties,” explained Procopio.

“Additive manufacturing is poised to bring about a revolution in the way drug products are designed, manufactured, and distributed to end users,” he concluded.

By:  Anna Maria di Giorgio
Editor in Chief, Pharmaceutical Engineering® Magazine