Overview of accelerated assessment and approval policies for cell and gene therapy products in the United States and Europe and its implications for ChinaWANG Jing, LU Shuang2441-2446
A brief analysis of the focus of production capacity research of autologous CAR-T therapeutic productsWANG Xue, MA Yan-song, WEI Wei, HE Wu2447-2451
Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccinesYANG Dan, ZHAO Xin, LI Xiao-jing, LI Min2452-2456
Several special considerations on the registration of post-approval changes for vaccines based on lifecycle managementJIN Su, GUO Sheng-nan, QIU Xiao, GUO Shu-yang, YIN Xiao, XIANG Jin-zhong, LI Min2457-2462
Considerations of pharmaceutical review of therapeutic recombinant protein drugs for subcutaneous injectionSAI Wen-bo, XU Long-chang2463-2466
Quality control and evaluation concerns of recombinant glycoprotein hormones:"macro"and"micro"heterogeneity of glycosylation modificationsLI Yi-jun, HU Ying-ying, WEI Wei2467-2476
Research progress and regulatory perspectives in neoantigen immunotherapyLI Qian, DAI Yi-fei, WEI Wei2483-2488
Risk management and technical considerations on donor screening for cellular therapy productsLIU Dan, JIA Dong-chen, CUI Jing, WEI Wei2489-2494
Research progress in SARS-CoV-2 neutralizing antibody products and pharmaceutical assessmentJIA Dong-chen, WU Zhou-yi, YU Peng-li2495-2500