Laurence Daheron, Phd, Head of the iPS Core Facility at the Harvard Stem Cell Institute, discusses the industrial challenges related to cell therapies: manufacturing, safety testing, administration mode.
Transcript:
We have to learn how to manufacture cells. So all these big biopharmaceutical companies are used to make drugs. And they’re good at this. But here it’s a new product, a totally different new product. It’s a cell and it’s very difficult to do the quality control on a cell compared to chemical compounds. So we have to reinvent totally new ways of dealing with drug delivery here, because the drug is a cell. So it’s gonna take a while but I think it’s really exciting because we are very close to getting the right cells. Now like we said, it is important to check if they are safe, and we have ways to check this, mostly using animal models. So you can make a big batch of cells and use this patch to test in animal models and to see if they form any tumor. And then if after six months – nine months – they don’t, you know that this batch of cells is good to go for patients.