Cell and Gene Therapy Technologist, Commercial Strategy, Strategic Marketing & Business Development
I found this an interesting read and thought I'd share. A reminder that patients are so much more complicated than the healthy donors we build our manufacturing processes on. #celltherapy #cellandgenetherapy #advancedtherapies
Owen Bain
11mo
Interesting. 7.4% failure rate is very high, unless I missed it, they do not specify what counts as a failure. They didn't highlight that one of the centres of manufacture had double the rate of failures than the other..
Nadimara Dias
11mo
Lindsey Clarke in which part of the body do I reverse dental anodontia?
Dr Fabio D'Agostino
11mo
True- thanks for sharing Lindsey
Accelerating Cell and Gene therapies to patients as Owner at R.H. Cell Therapy Consulting. Solving your Process and CMC problems by listening, not PowerPoint.
11moThis again highlights why process development in cell therapies is so hard. Only once you start working with patient cells, you start collecting real meaningful data on your process. That is exactly why I keep urging clients to plan for additional PD, and consequently process adaptations (with all the regulatory work that comes with that) during the clinical development. It may increase your time to BLA/MAA, but it will save you a lot ot trouble after.