Date: Aug 28, 2014 Author: Kathleen Gallagher,Mark Johnson Source: Journal Sentinel (
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Cellular Dynamics International Inc. said Thursday it has been granted a U.S. patent on the automated production of cells that can be grown into any of the more than 200 types of cells in the body.
The patent positions the Madison company, which makes human cells in industrial quantities, as the leading supplier of choice for scientists seeking a high-quality, reliable supply of human cells to use for research into new drugs and therapies, and stem cell banking, executives said.
"We believe that automation is critical to both large-scale manufacture of human stem cells and differentiated cell types, and their application, especially in cellular therapeutics," said Bob Palay, chief executive officer of the company, which is known as CDI.
CDI makes iPS, or human induced pluripotent stem cells and tissue cells. Like embryonic stem cells, these powerful cells can be grown into any of the body's cell types.
The patent becomes part of a robust portfolio of more than 800 that CDI has been awarded, has pending or has licensed.
"The ability of CDI to automate a process everyone thought you had to do by hand is a critical step in really building and expanding the power of stem cells," said Ulrich Broeckel, a researcher at Medical College of Wisconsin and Children's Hospital of Wisconsin. Broeckel is using cells made by CDI to study the genetics of heart disease and response to treatment.
"There are major efforts around the world to establish large banks of patient-derived iPS cells, and adding automation into an otherwise labor-intensive technology is welcome indeed," said George Q. Daley, a stem cell researcher at Boston Children's Hospital and Harvard Medical School, by email.
CDI sells its cells to researchers and most big pharmaceutical companies. Earlier this year, CDI announced an agreement with Nestlé SA through which the Swiss maker of Nescafé coffee, chocolate candy and other consumer products is using CDI's cells to develop nutritional products that help maintain health, manage chronic conditions or promote healthy aging.
The use of reprogrammed cells in science has "exploded over the last few years," said Kelly Shepard, science officer for the California Institute for Regenerative Medicine. CDI is using its automated production methods to work with the institute under a $16 million grant to create a biobank from the stem cells of 3,000 individuals.
The explosion of reprogrammed cells has raised a problem, Shepard said. Since different labs use different manufacturing methods, the cells they end up with have not been precisely the same.
Differences in the cells can cause confusion when it comes to results from an experiment. If labs at Harvard and University of Wisconsin-Madison conduct the same experiment, but use reprogrammed cells made in different ways, their results may vary. Another, even more basic question has surfaced among researchers since the discovery of cell reprogramming: What constitutes the standard for a fully reprogrammed cell?
Having these cells mass produced using the same method every time "provides a level of quality and consistency," Shepard said.
Being able to manufacture large numbers of cells that are the same will help scientists test drugs and observe how diseases unfold in a lab dish, she said. Eventually, doctors may be able to use these manufactured cells to treat patients in the hospital.
"In Japan, they're developing a bank of (reprogrammed cells) and contemplating using them for transplantation," Shepard said. "This would mean deriving tissue from those cells and actually using them in transplants at some point in the future."
There are many small government, academic and industrial research labs that are making iPS cells. And CDI has identified in filings with federal securities regulators other companies that have either announced an interest in, or begun to market, products based on pluripotent stem cell technology. Those companies include: Axiogenesis AG, Cellectis, General Electric Co., Life Technologies Corp., Lonza Group Ltd., ReproCELL and Sigma-Aldrich.
But CDI has said in filings with federal securities regulators that it is unaware of any competitor whose product offerings equal its own in quality, quantity and purity.
"CDI is the only company that really sees where this needs to go," Broeckel said.
Embryonic stem cell pioneer James Thomson and others co-founded CDI in 2004 with the goal of becoming the industry standard for manufactured human cells.
The Madison company, which has never turned a profit, raised $46.2 million in an initial public offering in July 2013. CDI sells to customers around the world nine cell types, including heart muscle, liver and certain types of brain cells, and continues to invest heavily in research and development.