Recommended Information
In vitro–differentiated Th1/Th17/Treg cells
Antibody-Dependent Cell-Mediated Cytotoxicity Assay (ADCC)
Antibody-dependent cellular phagocytosis
Complement-dependent cytotoxicity (CDC)
Cytokine Release Syndrome Risk Assessment (CRS)
Introduction to Neutralizing Antibodies Against Authentic Viruses
Currently, pseudovirus-based assays closely mimic physiological infection mechanisms and can largely replicate the in vivo therapeutic efficacy; however, there is a substantial discrepancy between neutralization assay results obtained with live viruses and those obtained with pseudoviruses. Therefore, live-virus neutralization assays are an indispensable step in the development of antiviral drugs and vaccines.
In CAR-T cell manufacturing, most retroviruses and lentiviruses used for cellular gene therapy are engineered as replication-deficient viral vectors and are co-transfected using multiple plasmids to express the lentivirus or γ-retrovirus. During production, homologous recombination may occur between the deleted vector backbone and wild-type viral sequences, leading to the generation of replication-competent virus (RCL), which poses a serious risk to human health. Therefore, RCL testing is one of the most critical components of safety assessment.