Interpretation of guidance on CMC study of in vivo gene therapy productsXU Long-chang, CUI Jing, HE Wu113-117
Interpretation of guidance on CMC study and evaluation of ex vivo genetic manipulation systemLU Jia-qi, LI Qian, HE Wu118-122
Interpretation of guidance on CMC study and evaluation of immune cell therapy productsYANG Fei, HAN Dong-mei, HE Wu123-127
Research on post-marketing drug risk evaluation and mitigation strategies of CAR-T therapies in US and its implication for ChinaWANG Jing, HUANG Yun-hong, ZHAO Chen-yang, LU Shuang, GAO Chen-yan128-133
General considerations for viral safety control in continuous manufacturing of recombinant biotechnology productsSAI Wen-bo, HU Ying-ying, WEI Wei134-137
Considerations on pharmaceutical evaluation of perfusion fermentation of recombinant protein biological productsQIU Xiao, SAI Wen-bo, KOU Ya-zhen, WEI Wei138-142
The concerns of CMC research and evaluation of antibody radionuclide conjugates productsWANG Xue, LI Qian, WEI Wei143-147
Considerations on CMC evaluation of human-derived stem cell productsHAN Dong-mei, HE Wu, WEI Wei, WEI Kai-kun148-153
General considerations on the chemistry, manufacturing, and control research of fermented new drugs for market authorizationZHAO Yi-fei, LIU Zong-ying159-162