“The one you need to change “, says Bob Preti, President and CSO of Progenitors Cell Therapy, “ And the later in the clinical development you change it the more expensive it is going to be”.
Bob talks about the Developed by Design approach he developed at PCT, a leading US-based contract manufacturing organization in the afternoon session, which Dave Smith (Lonza) opened with the question: “Can we actually deliver these cell therapy products at commercial scale at a reasonable cost?
Bob appreciates that we are creating therapies in a developing industry, but he likes to think that cell therapies will follow a similar path to personal computers.
One of the problems is that we do not really know the mechanism of action of the product and we do not know how to assess its potency. After all, the product is much more than just the process.
He also says that the process should be broken down into unit operations that can then be “upgraded” depending on the market demand for the treatment.
Technology landscape is rapidly evolving so he suggests “Buy if you can, Build if you must”.
So what does it take to successfully manufacture a patient specific cell product? “Get the people out of the process”, he explains.
With such an effective automated process in place for patient specific cell therapies production, I can see a bright future for PCT.
Certainly in countries like Japan and Korea who are both big fans of automation and autologous products. In fact, Bob told me that he will be in Korea next week and in Japan the week after that!
Just after Bob’s session, George Goldberger, VP Business development, told me that PCT is also looking to expand in EU to leverage their US capabilities and provide cGMP-compliant manufacturing services to our clients in support of their clinical trials across two continents.
Fabio D’Agostino for Total BioPharma at WSCRM Congress, London
Fabio D’Agostino is a research engineer at the Biopharmaceutical Bioprocessing Technology centre at Newcastle University