Bio-printing human parts will spark ethical, regulatory debate

3D printing also threatens intellectual property rights

The rapid development of 3D bio-printers will spark calls to ban the technology for human and non-human tissue within two years, according to research firm Gartner Inc.

In a report released today, Gartner predicted that the time is drawing near when 3D-bioprinted human organs will be readily available, an advance almost certain to spark a complex debate involving a variety of political, moral and financial interests.

An example of 3D printed liver tissue by a San Diego-based company named Organovo.

"At one university, they're actually using cells from human and non-human organs," said Pete Basiliere, a Gartner Research Director. "In this example, there was human amniotic fluid, canine smooth muscle cells, and bovine cells all being used. Some may feel those constructs are of concern."

Gartner also noted that 3D printing will change retail models and threaten intellectual property (IP), resulting in massive losses for companies that hold those licenses. In fact, Gartner predicts that by 2018, 3D printing will result in the loss of at least $100 billion a year in IP.

"The very factors that foster innovation -- crowdsourcing, R&D pooling and funding of start-ups -- coupled with shorter product life cycles, provide a fertile ground for intellectual property theft using 3D printers," Basiliere said.. "Already, it's possible to 3D print many items, including toys, machine and automotive parts, and even weapons."

John Hornick, an IP attorney with Finnegan, Henderson, Farbow, Garrett & Dunner LLP in New York, said as much at the Inside 3D Printing Conference last fall. "IP will be ignored and it will be impossible or impractical to enforce," Hornick said. "Everything will change when you can make anything."

3D bio-printing ethics

The technology of 3D "bio-printing", which uses extruder needles or inkjet-like printer heads to lay down successive rows of living cells, is advancing at breakneck speed, Gartner said.

Major challenges still face the industry, such as creating the connective tissue or scaffolding-like structures that support the functional tissue in a human organ. And, laying out living cells is one thing, but creating the vascular structure to support tissue with oxygen and nutrients is yet another challenge. Traditionally, tissue created in a lab dies before leaving the petri dish, experts said.

San Diego-based bio-printing company Organovo has overcome the vascular issue -- to a degree. "We have achieved thicknesses of greater than 500 microns, and have maintained liver tissue in a fully functional state with native phenotypic behavior for at least 40 days," said Mike Renard, Organovo's executive vice president of commercial operations.

Organovo hopes to be able to print a functioning liver this year. The organ would not be used for implant purposes, but for pharmaceutical testing and development.

Organovo's bio-printing technology creates functional human tissue. The company's bio-printer places a specially formulated "bio-ink" made of human cells into a 96 well plate. The process results in tissue with natural architecture that can be tested for drug development. It can also produce tissue for human transplant.

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