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
"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.
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 UW-Madison.
One of the current projects of Waisman Biomanufacturing is a
For projects related to embryonic stem cells, Waisman Biomanufacturing collaborates with WiCell, a nonprofit organization established in
Hei adds that one important goal of Waisman Biomanufacturing is to integrate the process of developing stem-cell therapies to encompass animal and human studies, while meeting
Developing drugs and stem cells is expensive, and streamlining research and development benefits both the university and
One example of Waisman Biomanufacturing's pivotal role emerges from a project with CDI and the
Cells derived from the super-donor stem cells will be tested by
Years of development remain for the patch idea but, ultimately, a patient with age-related macular degeneration could be matched with stem cells grown from a suitable super-donor.
Matching an off-the-shelf product to a patient is an important step toward consistency and cost reduction, Hei says. "Cost is a huge issue," since developing a unique line of cells for a single patient can cost
All the players in the super-donor project are in-state, Hei points out. "This is coming together, and it's all within
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