accepting cell lines derived by individual researchers who didn’t have the time to exhaustively characterize them, says Christman.
“We have developed very rigorous protocols,” Christman says. For example, before sharing a cell line with other investigators, Coriell checks iPS cells for chromosomal abnormalities that may have been inadvertently introduced by the researcher who first created them.
“One wants to be able to rigorously weed those out,” he says.
CIRM’s biobank will contain 3000 iPS cell lines for distribution, plus 6000 backup lines, that were all made by the same method. Coriell will maintain records about their derivation, their genetic characteristics, the intellectual property associated with the cells, and the consent forms of people who donated tissue for each cell line.
CDI will create the iPS lines with its most advanced proprietary method, which does not insert any new genes into the cell genome. In such “footprint-free” methods, the iPS cells don’t retain any of the genes that were used to “reprogram” an original skin or blood cell into a pluripotent stem cell.
CDI is betting it can create a profitable business supplying both iPS cells and specialized cells to stem cell banks and non-profit research institutions, as well as drug firms. In its IPO registration statement, the company estimates the total market for cells used in lab experiments at $3.5 billion. The stem cell banking market is currently $1.3 billion and is expected to reach $4.4 billion by 2020, said CDI, citing research by Adivo Associates. In its preliminary IPO prospectus, the Wisconsin company said its total annual revenue grew 154 percent in 2012 to $6.6 million.
CIRM’s biobank will contain iPS cell lines from hundreds of individuals for each of the 10 diseases that are the project’s focus. CIRM will own the cells, though CDI retains the intellectual property in its patented methods for deriving iPS cells.
Grieshammer says CIRM chose to focus on diseases that are controlled by complex genetic patterns rather than disorders triggered by only a few highly expressed genes. A more complete picture of diseases caused by the cumulative effects of multiple genes could emerge from analyzing cells from hundreds of patients with the same diagnosis, she says. Each research group can use the iPS cells to create the specialized cells best suited to answer its questions—whether it be drug toxicity revealed by liver cells, or a neuron’s response to a small molecule compound.
The hope is that iPS banks will make the path toward new therapies quicker and cheaper, because better drug candidates will be chosen for clinical trials, Grieshammer says.
“If this produces one drug that can help in one kind of disease that is common, it’s worth the entire investment,” Grieshammer says.
