Corporations engaged on induced pluripotent stem cell (iPSC) therapies face a dilemma automating their processes as a consequence of an absence of tailor-made gear. That’s the opinion of Cenk Sumen, PhD, chief know-how officer at Stemson Therapeutics, which is creating a therapy for hair loss and presently makes use of a comparatively guide manufacturing course of. Nevertheless, they hope to implement an automatic and closed manufacturing system over the following couple of years, Sumen explains.
Nevertheless, one problem, he says, is acquiring appropriate bioprocessing gear when, in contrast to extra established cell therapies, iPSCs solely make up a tiny share of the market.
“CAR-T is kind of a mature know-how now with a number of approvals, and various automation and closed techniques to bolster biomanufacturing,” he tells GEN. “The dilemma is how we get [instrument] corporations to spend money on automation for rising fields [such as iPSCs] after they’re not an enormous slice of the pie?”
One other problem for Stemson is how one can transfer from an instructional to an industrial protocol, says Sumen, who will likely be giving a chat in regards to the firm’s transfer in the direction of automation at BioProcess Worldwide in Boston in September.
“One of many greatest challenges is drawing packing containers round unit operations,” he factors out. “As soon as we’ve got iPSC, we’ve got to tradition them in a means decided by a particular protocol and the query is ‘how can we scale this?’”
Dealing with of the cells is presently a extremely guide course of. To automate this with robots, the corporate must isolate vital bioprocessing steps and eradicate pointless ones.
Stemson Therapeutics can also be engaged on designing a product formulation that works for his or her finish customers, who’re sometimes hair transplant surgeons.
“With surgeons, they need a product that matches with their present transplant protocol,” says Sumen. “And the whorl and swirl of hair follicles is particular person to every head.”
Their present product idea is a cryopreserved plate with a row of lab-grown hairs on it, which may sit on a surgical software station. This implies the hair follicles are able to be picked up and transplanted to a pre-determined location on a affected person’s head.