Oct. 17, 2013

A Waisman Biomanufacturing specialist examines cells in a culture in the cell therapy clean room. The UW-Madison Waisman Center opened Waisman Biomanufacturing to ease the research and development of biological products and drugs.

Photo: Waisman Biomanufacturing

Developing a new drug takes enormous amounts of time, money and skill, but the bar is even higher for a promising stem-cell therapy. Many types of cells derived from these ultra-flexible parent cells are moving toward the market, but the very quality that makes stem cells so valuable also makes them a difficult source of therapeutics.

"The ability to form many types of specialized cells is at the essence of why we are so interested in stem cells, but this pluripotency is not always good," says Derek Hei, director of Waisman Biomanufacturing, a facility in the Waisman Center at UW-Madison.

"The cells we can make from stem cells cells for the heart, brain and liver have amazing potential, but you can also end up with the wrong type of cell. If the cells are not fully differentiated, they can end up differentiating into the wrong cell type," Hei says.

Derek Hei

Just like drugs, stem cells for clinical trials must be produced under a demanding regulatory regime called "good manufacturing practice," he says. That capacity is rare in labs in private business and universities, and this is the only one at UWMadison.

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Biomanufacturing center takes central role in developing stem ...