By Kristin Brook, Contract Pharma | March 3, 2017
While the medical device segment is no stranger to 3D printing, this technology represents a relatively new approach for the pharmaceutical industry. Back in August 2015, the FDA approved the first drug product manufactured using 3D printing technology—Aprecia Pharmaceuticals’ SPRITAM, a prescription pill for the treatment of certain types of seizures caused by epilepsy in adults and children. The drug utilizes Aprecia’s ZipDose 3D printing technology platform to produce a porous formulation that rapidly disintegrates.
3D printing technology not only offers great potential to create drugs that are easier to consume and more effective, but also potential efficiencies throughout the research, development, and manufacturing process—even the supply chain.
Efficient manufacturing can be achieved since the active ingredients are added via 3D printers, offering the ability to produce high dosages and knowing that every dose will be exactly the same. This also implies that drugs can be customized for specific patients, with each dosage individually measured and printed.
Additionally, 3D printing technology may improve R&D, making the process less costly and more efficient. For example, the possibility to test drugs using 3D print sample tissues and organs instead of animals or synthetic models. Moreover, this technology might allow for new types of drug compounds based on new geometries and configurations made possible with 3D printing.
3D printing is estimated to grow into an $8.9 billion industry, with 21% projected to be spent on medical applications in the next 10 years.1 While this technology has many potential benefits, it also presents many complications for the pharmaceutical industry, and of course, the FDA approval process is critical to its success. While, the FDA seems quite open to the idea of 3D printing, the regulatory hurdles could be considerable.
Discussing the future of 3D printing in the pharmaceutical industry, David Hess, Solutions Consultant at Sparta Systems, also provides insights on benefits and challenges, safety concerns, and regulatory hurdles. –KB