The Benefits and Challenges of 100 Percent US-Based Manufacturing

Additive manufacturing allows pharma and biotech companies to take advantage of 3D printing technology to produce medications in a variety of dosages while achieving reliably consistent results. A major benefit of the process is the speed in which its able to produce a prototype and then shift to broad manufacturing.

Aprecia Pharmaceuticals is one of the key manufacturers using this technology. Aside from this, the company is also a 100% US-based manufacturer, which provides them with a unique benefit in the current ecosystem.

In April of this year, President Trump announced 100% tariffs on imported branded medications (with exceptions made for specific countries that negotiated their own tariff agreements). This is part of an ongoing push from President Trump to bring manufacturing back to the United States across all industries, including the pharma industry.

Kyle Smith, president and chief operating officer at Aprecia, spoke with Pharmaceutical Executive about the company’s additive manufacturing process as well as the benefits and challenges of 100% US-based manufacturing.

Pharmaceutical Executive: What are the benefits and challenges of 100% US-based additive manufacturing?
Kyle Smith: In terms of challenges, we're looking for key starting materials and APIs that come from the United States, and those are hard to find. We're often relying on sources from overseas, such as India and China.

Trying to find materials that are sourced in compliant areas for some of the projects that we're doing can be a little bit of a challenge. We've chosen to focus our efforts in the United States.

When we originally took these patents out of MIT and developed this technology, we realized it was something unique and special. There's a lot of skill sets in the United States, in terms of the workforce, to be able to commercialize these technologies.

From the partners we've used to develop the technology on the equipment, hardware, and software side, I wouldn't say there's been any challenges there. Certainly, we look globally for some of the suppliers and components that we use in building of our equipment in terms of a hardware and software perspective, but the challenges really are more on the sourcing of certain materials for projects.

The federal government, as an example, is focused more and more on how do we get some of these key starting materials back in the United States. How do we make sure that we've got key starting materials that we can use in developing APIs, and then go all the way through, finished drug product, and a rapid and agile manufacturing platform?