Cell Therapy Manufacturing & Gene Therapy Congress
Regulatory approvals and innovation drives: Cell therapies come of age
At today’s Cell Therapy Manufacturing & Gene Therapy Congress, delegates declared personalised cell and gene-based medicines are rapidly approaching maturity but still struggle with commercial production processes.
“The cell therapy field is in its teenage years,” Miguel Forte, CEO of Zelluna Immunotherapy, told a packed room in Amsterdam, The Netherlands. “But I have five children so I know very well how difficult those teenage years are. There is a lot of innovation and there’s a lot of value being brought, but there is still a struggle with quality.”
Forte said he moved into the space in its infancy, over a decade ago, when such therapies were deemed as “cute things,” but regulatory approvals now show the commercial reality of cell and gene therapies.
GSK’s autologous CD34+ enriched cell fraction Strimvelis was approved in the EU in 2016, for example, while the last few months have seen the US approve the first two chimeric antigen receptor (CAR) T-cell therapies: Novartis’ Kymriah (tisagenlecleucel) and Kite/Gilead’s Yescarta (axicabtagene ciloleucel).
And as it enters adolescence, the space is becoming more competitive, he continued. “Competition is great, it’s a huge driver for everything.” He explained the recent commercial successes have validated the manufacturing process, companies are now competing to make more efficient and productive platforms.
“It’s cashing in on established processes and being able to on to new approaches,” he said, adding there is now constant discussion among both vendors and end-users at developing technology advances while working from a common manufacturing background.
In follow up presentations, delegates from both successful CAR-T cell developers, Kite and Novartis, agreed with Forte that the sector is moving towards maturity. Lonza’s associate director of commercial development for cell therapies Nina Bauer added from the CMO’s point of view the sector is perhaps further along (“in its late-teenage stage”) but “is in a space where manufacturing and commercialisation challenges need to be looked at.”