Interpretation of guidance on CMC study and evaluation of antibody-drug conjugatesLI Qian, WU Yong-kai, WEI Wei, HE Wu561-565
Research on the development trend of viral safety control technology and requirements for biotechnology products:taking ICH Q5A(R2)as an exampleSAI Wen-bo, YU Peng-li, WEI Wei566-570
Common pharmaceutical issues and review considerations for biologics license applications of antibody productsZHAO Jing, WEI Wei, HE Wu571-578
Avoid using beta-lactam antibiotics and relevant resistance genes in prokaryotic-expressed therapy recombinant protein productsKOU Ya-zhen, WEI Wei, CHENG Su-yuan579-584
Review considerations for sequence variants of monoclonal antibody drugsWU Yong-kai, LI Qian, WEI Wei585-589
Discussion of common communication problems and review considerations of therapeutic recombinant protein biologicsKAN Hong-jin, WEI Wei, CHENG Su-yuan590-595
Considerations for quality study of recombinant protein-based radiopharmaceuticalsQIU Xiao, KOU Ya-zhen, WANG Xue, CHEN Hao, ZHANG Meng-meng, HE Wu596-601
Case study on the application of validation technology in viral clearance process platformCHEN Hao, HE Wu602-607
Research progress and CMC considerations on gene-editing medicinal productsLU Jia-qi, ZHOU Di, WEI Wei, HE Wu608-613
Development concerns and validation of flow cytometry method in CMC research of cell therapy productsWANG Jing-yu, Wu Xue-ling, WEI Wei614-618