As additive manufacturing has continued along the path of maturity, it has become strikingly clear the young technology excels when applied to the custom work of building intricate components.
With regenerative medicine or bioprinting, it just happens those custom components are made of living cells – and end up going into the human body.
"It's a fascinating concept of progress with long term goals that continue to expand. We have been working diligently for several years on solid organs. With the progress of the technology, we then open the aperture up for other human applications and now for laboratories," says 3D Systems President and CEO Dr. Jeffery Graves. "Considering the technological progress, a remarkable benefit to humanity exists to develop organ replacements or other biological implants to extend or improve the quality of life."
When 3D Systems first started working on biological projects it was through universities and independent researchers. "It was too early," Hull, co-founder and CTO of 3D Systems tells IndustryWeek. "These were researchers with good ideas, but there was not a clear path into an operating room where a surgeon would put something into the body to benefit the patient."
The first serious plunge into bioprinting started about four years ago when Hull’s team first started worked with Martine Rothblatt, CEO of United Therapeutics. The goal of the collaboration was to explore the feasibility of 3d printing a scaffold for a lung, an initiative that at the time had ongoing university research exploring the fundamentals of accomplishing the goal. Eventually the two companies entered a joint agreement where United focused on tackling the challenge from the anatomy and biology and cell perspective. And 3D Systems went to work on addressing the printing technology, material science and software aspects.
"When you put bright people together working on problems like this, amazing things happen," says Hull. "We were able to identify each of the problems to work on and started working on solutions."
While Hull is not ready to say they are able to print a lung, the significant progress is undeniable.Layers of challenges
Of course, operating within a young and emerging field like additive means constantly overcoming obstacles. However, regenerative medicine has its own set of interesting challenges. “The way research goes, you sort of discover the obstacles along the way," says Hull.
One such challenge – cells do not necessarily like to be taken out of their home and put in another home, explains Hull. “You have to figure out how to make them comfortable to thrive and do the job," he says.
Another challenge with any bioprinting project, achieving very high resolution is a necessity, which unfortunately means printing slower. As such, a lot of the technology evolution has been focused on printing fast enough to be practical, explains Hull. “Considering there are potentially billions of alveoli in a lung, the data requirement, data speed and data feed currently sets the limit,” he says.
The design is equally difficult. "You can take x-rays, do an MRI, but to actually understand the anatomy and biology well enough to produce a living organ is very difficult," says Hull.
After all 3D Systems has learned from the lung program, is at the point where it is looking to leverage its research tools and knowledge bast to partner with people who have other regenerative medicine applications.
Unfortunately, research alone does not immediately transfer to implanting medical devices in the body. The regulatory process with groups, like the FDA, is understandably quite stringent. After all, they need to be absolutely convinced and ensured that it's safe and effective.
Plus, the number of cells required to make a large organ is huge.
Bottom line: between showing feasibility, passing regulatory steps, and addressing the supply chain there are a lot of aspects the industry still needs to address.
Acquisition opportunity
Earlier this year, 3D Systems announced the acquisition of Allevi Inc. For the last several years, Allevi has developed lab scale printers of tissue samples for basic regenerative medicine studies. Now the group is starting to target pharmaceutical laboratories as well to print tissue samples to help aid in evaluating drugs and therapies.
“There's a lot of segments of the technology Hull's team has developed that apply to these lab scale printers,” says Graves. “Obviously, different applications, but the technology is transferable.”
"Our team has done a really good job in learning how to print hydrogels and biologically compatible materials," says Hull. "However, we don't traditionally employ a lot of biologists, but more biological people. The acquisition adds talented folks in that area, so we expanded our knowledge base on the printing side today, and we expanded on the biological side now as well."
Seeking milestones
Much like in other industries where additive has gained ground, each bioprinting application has its own technical milestones.
"From a business perspective, you often measure success by trying to start getting a real revenue stream where you are creating some value tangibly. With the shorter-term applications in the human body or even shorter term in laboratories, we are excited about turning this into a real revenue generating business,” says Graves.
Allevi already has a foothold in research labs, and 3D Systems hopes to expand its efforts. “Some of the European standards, for example, on the use of animal testing is more rigid rigorous than in the United States, which tends to make companies like cosmetic companies, more inclined to use lab studies,” says Graves. “By 3D printing tissue structures to study a facial cream's interaction with human cells, you can potentially accelerate approvals, while adhering to the animal testing requirements in Europe.”
It is these shorter-term applications that will continue pulling the technology along, while also bearing fruit for those investing in the space. "As that happens, we'll continue to fund from an R&D standpoint, the human applications," says Graves.
Better tomorrow
The precision, complexity and speed required to print these complex structures all goes back to the basics of industrial progression that's happened over the last decade – only with biological materials another level of complexity exists.
"I'm amazed by the timeframes folks are talking about in terms of getting printed components into a human body. But it will understandably require exhaustive demonstration and FDA approvals, which all takes time,” says Graves. “Looking back through the steps to progress towards the moon (Mercury, Gemini, Apollo) there was a clear objective that was seemingly outrageous in the beginning. But look at all the spin off technologies all the benefits that were never envisioned. I suspect this will be much the same way, there's some really high level, aggressive objectives, which will drive the technology and it'll spread into areas that we haven't even anticipated."
