Auxilium Biotechnologies 3D bioprinted eight implantable medical devices for repairing nerve damage aboard the ISS. (Image: Auxilium Biotechnologies)

Auxilium Biotechnologies has successfully deployed its 3D bioprinter aboard the International Space Station (ISS). The platform is the first of its kind, making history by printing eight implantable medical devices simultaneously in just two hours.

Microgravity provides advantages for bioprinting, including uniform material distribution and the ability to create finer, more intricate structures that would collapse under Earth’s gravity. These benefits are critical for implants that incorporate biological materials or therapeutic agents, delivering consistency and reliability that Earth-based manufacturing struggles to achieve. By harnessing the properties of microgravity, the company’s Auxilium Microfabrication Platform (AMP-1) can create medical devices with precision and efficiency.

The AMP-1 bioprinting system remains on the ISS, using lightweight cartridges preloaded with biological materials to print implants that are returned to Earth. It requires less than a minute of astronaut time per print session, minimizing costly labor valued at up to $130,000 per hour. The system’s lightweight cartridges ensure cost-effective and sustainable transportation via commercial resupply missions.

“The deployment of our bioprinter on the ISS is a landmark achievement for space biomanufacturing and Auxilium,” said Jacob Koffler, Ph.D., CEO of Auxilium. “AMP-1 is the most advanced 3D-printing platform ever sent to space, enabling us to develop regenerative medicine treatments that can transform patient care. This facility not only demonstrates the feasibility of mass 3D-printing production in space but also highlights the economic potential of space-based manufacturing. Bioprinting in microgravity will drive innovation benefiting life on Earth, aboard commercial space stations in Low Earth Orbit, and in future space exploration, including upcoming Moon missions.”

When the ISS is retired in 2030, the bioprinters will be on the new commercial space stations. Ten years from now, when the process becomes more commercialized, Koffler envisions this being sort of a new economic biomanufacturing system. Plus, since astronauts have access to satellite internet that works well, it could be operated remotely from Earth.

AMP-1's initial applications focus on producing implants for peripheral nerve repair, with future milestones including preclinical animal testing and commercialization. In the near term, these implants will be used on Earth, while longer-term applications aim to support space exploration, including missions to the Moon, Mars, and beyond. The ability to bioprint implants in space could significantly improve medical care for the crew during long-duration missions.

Auxilium Biotechnologies 3D bioprinted perfusable vasculature aboard the ISS, demonstrating the ability to print blood vessels. (Image: Auxilium Biotechnologies)

Here is an exclusive Tech Briefs interview, edited for length and clarity, with Koffler.

Tech Briefs: What was the biggest technical challenge you faced while developing AMP-1?

Dr. Koffler: The biggest challenge we had was the cartridge itself, because we had to go through several safety reviews with NASA. Anything that touches the astronaut needs to be highly reviewed and safe. So, we needed to do several revisions of the design and manufacturing of the cartridge before it passed review.

Tech Briefs: What was the catalyst for this project? How did it all get going?

Dr. Koffler: We wanted to improve manufacturing of one of our aspects of the 3D printing technology when we use drug delivery. When we 3D print those devices here on Earth, the drug delivery particles sink and we thought that maybe in microgravity they won't sink. That was really the idea behind it. We talked with NASA, and there is the InSPA [InSpace Production Applications] program — manufacture in space in order to benefit Earth. It's a certain portfolio that focuses only on technologies that you can develop in space to bring back here. That was a good fit. We applied, were selected, and we're looking forward to running this study.

Tech Briefs: Can you explain in simple terms how it works?

Dr. Koffler: The implant is for peripheral nerve injuries. If you, for example, were involved in a car accident or you worked in the kitchen and you cut your hand by mistake and now you don't have control over your muscles, skin, whatever; those are all peripheral nerves. If the cut is big enough that there is a gap, you need some kind of a bridge to put there that will help facilitate regeneration. We have a best-in-class bridge that helps the nerve regenerate. It not only supports regeneration, but it also organizes regeneration. So, the nerves reach where they need to reach. One issue is regeneration, bridging the gap. The other issue is getting to the right point, getting to the right target. Sometimes, what you see is that nerves, even if they're able to bridge the gap, they innovate different targets. Our device also organizes regeneration to bring the nerves to the right target.

Jacob Koffler, Ph.D., CEO of Auxilium. (Image: Auxilium Biotechnologies)

Tech Briefs: What is the difference between 3D printing in space with microgravity and here on Earth?

Dr. Koffler: The difference for us is the ability to organize the materials in specific distribution that we want them to be. We don't need to go to space to 3D print, unlike others. But there is a certain aspect of 3D printing that we need to optimize, and we think it can only happen in space: distribution of material. So, for example, we also work on bioelectronics. We incorporate conductive materials into our devices. Same concept. If we want uniform distribution or uniform conductivity throughout the device, we will probably need to do that in microgravity.

Tech Briefs: The article I read says, “AMP-1's initial applications focus on producing implants for peripheral nerve repair with future milestones, including preclinical animal testing and commercialization.” How do you plan to accomplish this?

Dr. Koffler: What we need to do next for this specific program, we need to start taking those implants and putting them in animals. So, the first big question before you're talking about efficacy, if it actually works, is because it's manufactured in space and it's an environment that no one has ever manufactured in and brought back — certainly, the FDA has no guidance about — we will need to start generating data. It's something that people talk about in the community, but, no one has ever done anything with it. We definitely have plans to start manufacturing several devices, bringing them back, and then doing the biocompatibility studies to show here, you know, we can make things in space that are not toxic, biocompatible, which implies that the environment can be used as a manufacturing environment. It improves the business case of the manufacturing environment in space.

Follow-up studies will be, of course, to look at efficacy to show that those devices that are manufactured in space are actually doing what they're supposed to do. And once all of that is working, you go to a clinical trial.

Tech Briefs: Is there anything else you'd like to add that I didn't touch upon?

Dr. Koffler: This is the first time that a company is able to show mass production of medical devices in space. We've showed 20 printing sessions with more than one print session during a day. Multiple structures printed within one session. No one has done this before. People did maybe one session in the past. So the mass production, the precision, the ability to create devices with high resolution, and intricate designs, that's really another strong part of what we do. Finally, the ability to do that really remotely with minimal astronaut time. That's extremely important for anybody who's trying to build a business case for manufacturing in space. Astronaut time is expensive. And, if you can do anything independently or with minimal time, it's of high value. So, those are really the things that we were able to demonstrate in this mission.

Topics:
3D Printing & Additive Manufacturing Aeronautics Manufacturing & Prototyping Materials Spacecraft

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