About the 3D BioFabrication Facility (BFF)
The 3D BioFabrication Facility (BFF) and the Techshot ADvanced Space Experiment Processor (ADSEP), together comprise the first-ever system capable of manufacturing human tissue in the microgravity condition of space. Utilizing adult human cells (such as pluripotent or stem cells), the system can create viable tissue in space through technology that enables it to precisely place and build ultra-fine layers of bioink – layers that may be several times smaller than the width of a human hair – involving the smallest print tips in existence.
The Apollo program captured and united the imaginations of the people of this nation and the world. In an era when commercial companies compete to do in space what previously was only thought possible by sovereign nations, the addition of BFF to the ISS is a “Moonshot for the 21st Century.”
While researchers have seen some success with the 3D printing of bones on Earth, the manufacture of soft human tissue, such as blood vessels and muscle, has proven more difficult. On Earth, when attempting to print with soft, easily flowing biomaterials that better mimic the body’s natural environment, tissues collapse under their own weight – resulting in little more than a puddle. But if these same materials are used in space in a microgravity environment, 3D-printed soft tissues will maintain their shape.
Without proper conditioning, space-printed tissues also would collapse if immediately returned to Earth. Operating in space along with BFF is a Techshot-developed cell-culturing system that strengthens the tissue over time, to the point where it becomes viable and self-supporting once back in the Earth’s gravity. Whereas the tissue printing process may take less than a day, the strengthening process can take 12 to 45 days, depending on the tissue.
In July 2019, BFF was launched aboard the uncrewed SpaceX CRS-18 cargo mission from Cape Canaveral for delivery to the International Space Station.
The first phase for BFF, which could last approximately two years, involves creating test prints of increasing thickness. The next phase, where heart patches are manufactured in space and evaluated on the ground (under a microscope and in animals), could last through 2024. The manufacturing of whole organs in space would not likely be attempted until much later.
The path to regulatory acceptance of replacement human organs that were manufactured in space is anticipated to be very long – taking perhaps 10 years. Concurrent with Techshot’s own plans, the company also is leasing use of BFF to other research teams who may have more aggressive timelines for their projects.
Also, BFF may have a role in deep space exploration, where it could be used to make food items, and/or enable the remote formulation of drugs optimized for each crew member.
The challenges are many, but the potential benefits far outweigh them. It will require patience. But Techshot has been building space research equipment for more than 30 years and it understands very well how to continually improve processes.
Besides the technical challenges that must be overcome, Techshot expects years of work to achieve regulatory approval for its space-manufactured tissue. The company wants BFF to benefit patients on Earth as quickly as possible, which is why Techshot allows other research groups to use it in space. The prospect of creating whole organs in space is real – but still many years away.
Techshot’s process is quite scalable. While it is too soon to speculate on specific numbers, someday BFF stands to make an impact on transplant waiting lists. One potentially-limiting factor in scale-up is the availability of rack space in orbiting vehicles. The International Space Station is near capacity.
But Techshot is not limited to the ISS. It already has signed preliminary agreements with commercial enterprises that are creating their own orbiting microgravity laboratories for research and manufacturing.
The long-term success of BFF as a manufacturing system brings an array of prospective medical breakthroughs, including:
- reducing the organ donor shortage (there are about 113,000 people on transplant waiting lists)
- creating patient-specific replacement tissues or patches
- the possibility of transplant recipients receiving organs comprised of their own stem cells, thus reducing likelihood of rejection, and reducing long-term costs associated with a lifetime of anti-rejection drugs, and perhaps additional transplants
- eliminating the requirement that someone must first die in order for another person to receive a new heart or other organ
- testing drug efficacy using Techshot-manufactured tissue
Though years away, the ideal candidate for tissue manufactured in space will be someone who’s alternative treatment plan includes a lifetime of expensive anti-rejection drugs for a donor organ, many of which have their own unwelcome consequences. Some patients also require multiple transplants over their lifetime. Tissue manufactured in space from the patient’s own stem cells will not require anti-rejection drugs. Therefore, the overall lifetime cost for a single transplant is expected to be lower for the patient receiving tissue manufactured in space than the alternative.
Two high-tech companies have teamed up to develop the technology capable of manufacturing human tissue in space: Techshot Inc., a commercial developer and operator of spaceflight equipment for more than 30 years; and nScrypt Inc., a manufacturer of the world’s most advanced industrial 3D bioprinters and electronics printers.
Techshot: The company’s Space Act Agreement with NASA permits it to commercially operate its own equipment aboard the station — serving as an on-ramp for anyone who wants to conduct research and/or manufacturing in space. It also has served as an official Implementation Partner for the International Space Station U.S. National Laboratory since the lab’s creation. Besides the ISS, Techshot devices have flown aboard parabolic-flight aircraft, sub-orbital rockets, space shuttles, the Northrop Grumman Cygnus, and the SpaceX Cargo Dragon.
The company has a large catalog of available space research and manufacturing payloads. Since 2015 the Techshot designed, built and operated Bone Densitometer has been conducting X-ray evaluations of mice in space for biopharma companies such as Novartis and Eli Lilly. The Techshot Multi-use Variable-gravity Platforms have been aboard the station since April 2018, serving customers such as AstraZeneca and researchers at NASA and MIT. Founded in 1988, Techshot is headquartered in Greenville, Indiana, and it has an office and laboratory at the Kennedy Space Center in Florida.
nScrypt: Founded in 2002 and headquartered in Orlando, Florida, nScrypt designs and manufactures award-winning, next-generation, high-precision Micro-Dispensing and Direct Digital Manufacturing equipment and solutions for industrial applications, with unmatched accuracy and flexibility. Serving the printed electronics, electronics packaging, solar cell metallization, communications, printed antenna, life science, chemical/pharmaceutical, defense, space, and 3D printing industries, its equipment and solutions are widely used by the military, academic and research institutes, government agencies and national labs, and private companies.
nScrypt’s BAT, the world’s first commercially available bioprinter, which was developed under a contract with the Defense Advanced Research Projects Agency (DARPA), won R&D Magazine’s 2003 Top 100 award. www.nscrypt.com
nScrypt CEO Ken Church has a very personal stake in BFF. Twenty-five years ago his daughter was born with one lung and was given a 10 percent chance of survival. She survived, and today lives an active and full life despite her missing lung. “But why,” Church said, “can’t we make her another lung.”
Twenty-four years ago, of course, Ken’s question was a non-starter. Creating a lung was impossible. Today, the answer to the question is much different. While assembling a human lung or other organ is still years away, BFF presents a roadmap.
“At a conceptual level, it’s not that tricky,” said Church. “This BFF team knows how to get there. But it will require baby steps and patience. I have no doubt someday BFF will provide someone like my daughter with a second lung.”