So glad this is getting more attention. Recall that many of us in the CMC gene therapy field were barking about this when EU approval docs began to circulate. There seems to have been zero comparability established between processes (site, scale, process, cell line, downstream and formulation all different) and common CQAs well outside e…
So glad this is getting more attention. Recall that many of us in the CMC gene therapy field were barking about this when EU approval docs began to circulate. There seems to have been zero comparability established between processes (site, scale, process, cell line, downstream and formulation all different) and common CQAs well outside established norms for acceptance criteria. JNJ and Moderna were no different and the bars were lowered without any explanation. One more element of total regulatory disaster and MSM wonder why trust has been lost.
So glad this is getting more attention. Recall that many of us in the CMC gene therapy field were barking about this when EU approval docs began to circulate. There seems to have been zero comparability established between processes (site, scale, process, cell line, downstream and formulation all different) and common CQAs well outside established norms for acceptance criteria. JNJ and Moderna were no different and the bars were lowered without any explanation. One more element of total regulatory disaster and MSM wonder why trust has been lost.