Cell Therapy Manufacturing & Gene Therapy Congress

Regulatory approvals and innovation drives: Cell therapies come of age

By Dan Stanton

- Last updated on GMT

Regulatory approvals and innovation drives: Cell therapies come of age

Related tags Cell therapy manufacturing Gene Cell therapy manufacturing & gene therapy congress

Cell therapies have reached their 'teenage years' and must now overcome processing efficiencies and quality struggles, say industry delegates.

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.”

Related news

Show more

Related products

show more

Trends in Biopharmaceutical Raw Material Selection

Trends in Biopharmaceutical Raw Material Selection

Actylis – The Partner of Choice | 31-Jan-2023 | Business Advice

Join us as our in-house experts, along with Cecile Bellamy from Pfizer, discuss current and future trends in biopharmaceutical raw material selection.

Liposomal and Nanoparticle Technology

Liposomal and Nanoparticle Technology

Pfizer CentreOne | 18-Nov-2022 | Technical / White Paper

Medical science is continuously searching for better ways to administer drugs into the body and to maximize the therapeutic effectiveness of the drugs...

Connectivity & Integration in Biomanufacturing

Connectivity & Integration in Biomanufacturing

Wheeler Bio | 17-Nov-2022 | Technical / White Paper

As the Pharma 4.0 initiative sets a new industry paradigm, more biomanufacturing companies are asking how they can design and build facilities that apply...

GMP manufacturing of buffers and liquid blends

GMP manufacturing of buffers and liquid blends

Actylis – The Partner of Choice | 16-Nov-2022 | Technical / White Paper

Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in compliance...

Related suppliers

Follow us


View more