Friday, May 23, 2014

Printing Replacements

By Robert Fee, Editor-in-Chief, Bioscience Technology

“Gentlemen, we can rebuild him. We have the technology. We have the capability to make the world's first bionic man.”

Though focused on mechanics, the Six Million Dollar Man serves as a good introduction to the concepts, and promises, of regenerative medicine. 3-D printing promises to revolutionize engineering, and many speculate that it could have a huge impact on medicine, too. Many speculate that useful organs grown in the lab three-dimensionally on scaffolds is now closer to fact than fiction. This creates much excitement.

Prizes are already in place for the team that successfully prints a liver, as one example, and transplants it into an animal recipient that survives. Implantable organs might be the most exciting promise, but others, such as producing organs specifically for toxicology studies, might be more practical and provide a greater impact.

The processes and regulatory challenges in taking this technology from the lab to the patient, however, are significant.

Process hurdles
One ultimate goal is mass production of printed organs— removing transplant donor waits and minimizing rejection issues. But what happens after tissue printing experiments become accepted treatment options? How will these be taken from the lab to the bed side? No one knows yet. There are no standard process regulations, or even best practices, in place. Some, however, are starting to lay the foundation for automation and, eventually, commercialization— working to take a process that is very expensive and has a low yield and streamlining it to the point where it can be done cheaply and reliably.

North Carolina State University’s Edward P. Fitts Department of Industrial and Systems Engineering (ISE) is one group working to achieve this goal.

“It is one thing to be able to grow an organ but another to take that ability to the bedside, so involving manufacturing engineers early on in the biological research phase is vital to achieving commercialization,” says Dr. Binil Starly, associate professor of regenerative medicine at NC State’s ISE.

Starly’s group is attempting to kick start a program that looks at the manufacturing aspects of regenerative medicine and helps to identify the scale-up issues. ISE identified variability in methods as a crucial issue to be addressed. By tracing the processes and documenting each step, they quickly realized that more standard operating procedure (SOP) was needed.

“When you have humans involved, you’re going to have variability,” says Dr. Ola Harryson, associate professor, Fitts Fellow in Biomedical Manufacturing at NC State’s ISE. “People will do things differently, and that will affect the outcome. So the first thing we tried to do was standardize these processes to reduce the variability in the yield. That was a big step.”

A second concern: quality control. A key element in any automated system is the sensors that ensure the work being done is up to snuff. When you’re dealing with biological processes, these gain even more importance. As Harryson puts it, “you don’t want to keep culturing something that is already out of control.” Unfortunately, the technology is not quite there yet, but it’s getting closer.

“The technology definitely needs to catch up,” says Starly. “I think people are still trying to define what we are trying to sense. Once that can be defined, then sensors can be developed around that.”

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