California Biomedical Industry - California Healthcare Institute

For Keirstead, however, the mostpressing question for the emerging stemcell therapy industry is manufacturing.“The greatest challenge of stem cellresearch is to get a stem cell that canbecome any type of cell to becomea single type and produce it in largenumbers at high purity,” he said.The manufacturing process isconsiderably more complicated thanfor small molecules or even biologicproducts, he said. It requires exquisiteexpertise — workers who have boththe skills to work with the cells andthe judgment to know exactly when toperform the necessary steps. Stem celltherapies will require slower and moreexpensive manufacturing techniquesthan the biomedical industry currentlyuses, and a more rigorous regulatoryframework to match.He said that the downside of being in sucha new discipline is that the risks have notall been identified. As an example, he saidthat stem cells are grown on plates. As theplates fill, some of the cells are off-loadedto new plates and so on. Each generationis called a “passage.” Researchers in hislab discovered that at about 70 passages,the cells start to misbehave.It was not an expected development: 70passages occurred some five years intohis work.He could not be more excited, though.The science is “still at very, very earlystages. As a basic research scientist, Iam shocked at how many discoveries wemake daily. The potential is enormous.”Still, Keirstead said, “The overwhelmingtenor [regarding stem cell-relatedtherapeutics] has been progressivelyenthusiastic.” He said he sees a lotof enthusiasm among investorsand government and that majorpharmaceutical and biotechnologycompanies are building stem cellcapabilities, currently throughacquisitions and sponsored researchcontracts. He said they also areapproaching researchers regarding newdiscoveries, “which is a positive signal foryounger companies and academicians.”“Stem cells have incredible potential,”Keirstead said, adding that their greatestbenefit may be in informing conventionaldrug discovery. “We have no source forhuman tissue now. We use animal tissueor human tumor lines. Stem cells, for thefirst time in the world, are being usedto make heart cells. Using human heartcells [generated by stem cells for drugdiscovery] will increase hits dramaticallyand dramatically decrease costs,” he said.98 | California Biomedical Industry 2011 Report