Utilizing 100-Percent Domestic Additive Manufacturing: Q&A with Kyle Smith

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: How is additive manufacturing applied in pharma and biotech?
Kyle Smith: Aprecia has a unique 3D printing technology based on binder jet 3D printing. It's a powder liquid process, and we use our technology to develop and manufacture unique dosage forms, and to do that rapidly.

Obviously, there's a lot of time pressure from folks in pharmaceutical and biotech industries now to develop products to the market more rapidly. There's a very competitive landscape in a lot of these disease states, so we're trying to provide that edge to our partners to develop patient-friendly dosage forms, products that are difficult to develop and manufacture with traditional manufacturing technologies, and to do that in a rapid environment.

Obviously, 3D printing was originally known as more of a rapid prototyping technology, and we've taken that rapid prototyping nature and applied that to development manufacturing. We're able to quickly develop proof of concept and do some feasibility work to show that a molecule can work on the platform.

We’re developing a near final dosage form, so it's a really patient-friendly dosage form that's ideal for both administrating the product, if you're a caregiver, or for the patient to actually take the product. We're able to provide this unique, really beneficial dosage form, do it quickly, and do it in, obviously, a CGMP compliant way with our technology.

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?

Pharmaceutical Executive: How is DARPA helping to bring additive manufacturing to US shores?
Kyle Smith: EQUIP-A-Pharma is run through DARPA, and now ASPR is really the partner that we're moving into partnership with on that program. What they're trying to do is encourage rapid manufacturing platforms to be developed in the United States for the manufacturing of APIs and the manufacturing of finished dosage forms.

There's a focus on finding the right key starting materials and developing these processes and submitting AMDAs to get these products approved for products around the drug shortage list to start, because there's obviously several products that are coming from overseas, and whether it be tariffs, whether it be international affairs, or whether it be market conditions forcing some products to go on the shortage list, that obviously can have do harm to patients in the United States.

They want to make sure we've got more control over that supply chain, so DARPA and the federal government are really incentivizing companies with investment to bring manufacturing back to the United States.

Pharmaceutical Executive: How can 3D printing technology speed up US drug production?
Kyle Smith: What we do from the start is take a well-characterized system, so we can understand what the design space is in terms of the powders, liquids that we're using, compatibility issues. We're able to map these things out before we start the process, and we have a good understanding of critical process parameters and the target product profile that a client would be shooting for.

There's a lot of work that we can get done ahead of time before you hit the machine and actually develop the product and have a high level of confidence that what we plan to manufacture is going to be successful just based on all the knowledge and the incredible amount of data that we've been able to capture.

Once we're actually on the machine, we have a lot of process analytical technology, such as NIR probes, cameras, laser cameras, and we're looking at the content of the powder that goes in, the amount of powder that goes into any tablet, the amount of liquid that goes into any tablet, and the content of that liquid. That's a lot of data points for any one tablet.

We can have 22 data points in real time as it's being built layer by layer, and that can be tracked back to the individual tablet. Rather than running a batch or a set of batches, sending material off to the lab, and waiting for analytical testing( which often can be a delay and take time as the lab gets built up with kind of the queue), we're able to get all this data in real time and track it back to individual cavity.

We can make quicker decisions based on real time quality and in process analytics, and then you can move on to the next set of experiments. You're able to rapidly iterate through, just based on the data collection and the sensors that we have on the machines that give us real-time feedback on the quality of the products.