The next wave of manufacturing: Human Organs
If manufacturing is a manifestation of creativity, then the gold at the end of the rainbow may be the ability to manufacture that which sustains human beings — their organs.
While growing cells has been feasible for years, what has not been possible until now is the ability to actually produce tissue that in turn becomes a fully functioning organ.
But technology has advanced to such a level, through the use of 3-D printing, that scientists, and now companies, can layer cells on a bioprinter and produce tissue. The tissue will eventually be turned into implantable full-scale human organs.
“The ability to manufacture living human tissue for medical research and clinical practice has the potential to reshape the future of medicine,” said Keith Murphy, CEO at Organovo, a San Diego-based company that designs functional human tissues.
And the need is great: Every 30 seconds a patient who could have been saved with tissue replacement dies.
“The power to deliver human tissue for transplant can help us impact even more patients, hopefully one day including those on organ transplant lists,” said Murphy.
So how did scientists discover they could manufacture living tissue? One of the first discoveries was by Doris Taylor, who was the director of the University of Minnesota’s Center for Cardiovascular Repair. In 2008, Taylor’s research team was able to strip organs of their cellular make-up, leaving a decellularized “scaffold.” The organs, such as heart, kidney, pancreas, lung and liver, could then be reseeded with cells that, when supplied with blood and oxygen, regenerate the scaffold into a functioning organ.
Moving from the lab to commercialization of this decellularization technology was achieved when Miromatrix Medical Inc. of Eden Prairie, Minn., received an exclusive global technology license with the University of Minnesota based on Taylor’s research and became operational in 2010.
In deciding what to bring to market first, Robert Cohen, CEO of Miromatrix, explained that the decision to create MiromatrixBiomesh, a cardiac-derived biomesh, involved both the size of the potential market ($2 billion and growing) as well as the willingness of clinicians to use new and improved products.
“We also considered the benefit to our shareholders of a rapid entry into the commercial marketplace due to a 510(k) review pathway at the FDA,” Cohen said. The product is expected to come to market within the next two years.
Cohen also said the relative ease of manufacturing was important. The company built its own plant to manufacture the product.
“We believe that our technology eventually will enable the replacement of entire organs harvested from donors, stripped of their cells and either transplanted as a biomesh or recellularized from the recipient or compatible cell lines,” said Cohen.
Source: Industry Week
Published: 06 June 2013
Category: Features, Technology & Devices