Physical and Chemical Characterization
The structure of a drug determines the nature of its existence. Therefore, analyzing the physicochemical characteristics of the drug is the key to the research and quality control of antibody druggability. The main contents of the physicochemical characterization analysis of antibody drugs are as follows:
Analysis of antibody fragmentation characteristics using SDS-PAGE electrophoresis
Analysis of Charge Heterogeneity of Antibodies Using citation exchange (CEX) Liquid Chromatography
Analysis of antibody modification (glycosylation characteristics) or characterization of antibody peptide map information using reverse phase chromatography (RPC)
Analysis of antibody isoelectric point information using the capillary isoelectric focusing (cIEF) method.
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Binding Specificity
1. The specificity of antibody binding to cell surface receptors (antigens) is tested by flow cytometry.
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2. The specificity of antibody drugs binding to antigen is tested by ELISA.
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Functional Activity
The binding of antibodies to cell surface receptors or antigenic substances will cause changes in cell function and produce certain biological effects. The efficacy of antibody drugs is mainly achieved through the combination of antibodies with receptors or antigenic substances on the cell surface. Therefore, the evaluation of drug activity can be carried out by observing the changes in cell function. The main types of cell functional experiments for antibody drug activity analysis are:
CDC (complement-dependent cytotoxicity) assay
ADCC (antibody-dependent cellular cytotoxicity) assay
Cell proliferation inhibition assay
Phacocytosis assay
The reporter gene technique to monitor the cellular events associated with signal transduction and gene expression.
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