Manufacturing Mind the skills gap
There’s a skills shortage in the world of cell and gene therapy. This isn’t news; the problem has endured for years without a solution – but could that be because there isn’t one? Peter Littlejohns asks academic turned consultant William Janssen, who has spent a lifetime researching and applying cells in cancer clinics; Sarah Stoll, director of biomanufacturing consultancy Project Farma; and James Kusena, head of bioprocessing at cell manufacturing technology start-up MicrofluidX, whether the talent shortfall can be overcome.
typical lot of Tylenol may have several million capsules in it,” says cell and gene therapy consultant William Janssen. “But Johnson & Johnson probably only makes half a dozen lots a year.” These numbers are unlikely to square with manufacturing dossiers at J&J; after all, Janssen didn’t spend a lifetime working there, a fact that couldn’t be made more evident when he doesn’t refer to the pharmaceutical wing of the medical device giant by its correct name (Janssen), even though it’s the exact same as his own. He did spend it researching and producing cancer therapeutics though, which is why his next
T
he pharmaceutical industry wouldn’t thrive to the extent it does without having the ability to manufacture at such a large scale. “A
statement illuminates how much the cell and gene therapy sector differs from its much larger sibling: “One lot of CAR-T cells is a single dose. We need two people per dose, with two weeks to make a dose, and there’s only 52 weeks in a year – that’s 26 doses a year.” To an extent, long lead times are an inherent limitation of manufacturing a product using living matter, especially when the process involves differentiating cells from one lineage to another. “Because these are typically based on how nature does it, you can only force it and mimic it to a certain extent,” explains James Kusena, head of bioprocessing at MicrofluidX. “If you can fine-tune the process then you can shorten it, but you’re not going to drastically turn a 14-day process into one day.”
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