Immunization is to use target antigens to select appropriate animals (such as mouse, llama, rabbit) for immunization, to prepare specific antibodies with strong specificity, high affinity, and high titer. The selection of an appropriate immunological regimen is critical to the success of cell fusion hybridization and thus the production of high-quality antibodies.  
 

In the early drug development process, antibody screening and optimization is an important step. At present, the conventional technologies widely used include hybridoma technology, antibody library screening technology, B cell cloning technology and other screening technologies. Common methods include ELISA and FACS cell level binding and blocking, SPR/BLI affinity detection, etc.

Only antibodies that can cause species cross-reaction can be used in preclinical animal experiments to verify and evaluate the efficacy of antibodies. Therefore, species cross validation is an important step in the process of antibody drug development. Common species cross-validation methods include ELISA, SPR, BLI, and flow cytometry.

Only antibodies that can cause species cross-reaction can be used in preclinical animal experiments to verify and evaluate the efficacy of antibodies. Therefore, species cross validation is an important step in the process of antibody drug development. Common species cross-validation methods include ELISA, SPR, BLI, and flow cytometry.

The function of an antibody depends on the epitopes it binds to the antigen. Depending on the epitopes, antibodies perform specific functions, such as activating or inhibiting activity. A good antibody candidate requires high specificity and appropriate affinity for functional epitopes. Therefore, the structural analysis of antibody drugs at this stage is mainly site analysis, and commonly used methods include SPR, BLI and ELISA.

Antibody modification includes humanization, Fc affinity modification and druggability modification. It focuses on the optimization of immunogenicity, affinity maturation and other issues, aims to find a balance between effectiveness and safety. ELISA, SPR/BLI and other methods were commonly used to verify the affinity changes, cell function changes and ADCC/ADCP/CDC cell function verification before and after the modification.

Properties of therapeutic antibody include physical, chemical, and biochemical characteristics, determined by the protein's sequence and structure, which can vary with specific targets. Drugability is the inherent property of the molecule, primarily established during early sequence modifications, but influenced by subsequent manufacturing processes (e.g., aggregation, degradation) and clinical trials (metabolism, pharmacology, immunogenicity). Therefore, evaluating the drugability of antibody drugs is crucial.