Lonza: ‘Get CGT processes correct early to avoid late-phase pitfalls’

Lonza says its expertise in the cell and gene therapy space can help sponsors quickly bring products into the clinic and towards commercialization.

Contract development and manufacturing organization (CDMO) Lonza is a major player in the advanced therapy space, with facilities in Geleen, The Netherlands and Houston, Texas – the latter described by the firm as the world’s largest dedicated cell and gene therapy manufacturing plant.

Speaking at the Cell and Gene Manufacturing and Commercialization (CGMC) Conference in Amsterdam, The Netherlands last week, the firm said its proven expertise in the field places it as an optimal partner for sponsors looking to bring their therapies into and through the clinic as fast as possible.

“We have three commercial products approved that are being currently manufactured at Lonza’s cell and gene therapy [facilities], so we do have quite a bit of experience,” Ravi Vyzasatya, head of Cell Therapy Development Services, Cell & Gene, Lonza, told BioProcess Insider.

“We know the minefields, the risks for you to watch out for […] we help the sponsors get on and avoid those pitfalls and minefields so that they can successfully commercialize their therapy.”

He added for every client, Lonza conducts a “new product introduction procedure” to establish the baseline process and to identify potential process risks before proceeding, as ensuring success early on avoids problems further in development.

“Some of the decisions that you would take to get to the clinic faster in the early phases come back to haunt you when you go to commercialization. It could be certain unit operations that are not very optimal, or it could be a scale that is not appropriate for later stage commercialization, or it could be a matter that is not validatable at a later stage for you to commercialize your therapy.”

Watch the full interview below: