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The application of monoclonal antibodies (mAbs) and antibody drug conjugates as biologic drug therapies is an area of highly active research. Antibody characterization is an essential part of the biopharmaceutical development process. It is needed to differentiate among biologics/biosimilars, to help screen mAb drug candidates, to optimize production processes, and to satisfy regulatory requirements. Initially, the generation of monoclonal antibodies involved fusing cells from tissues and tumors to create hybridomas—a costly and often low-yield undertaking. Today, cell-line development and more efficient manufacturing techniques have emerged. Furthermore, a range of methods are used to determine the class and subclass of the antibody, including ELISA, radioimmunoassay, surface plasmon resonance, Western and dot blotting, mass spectrometry, and flow cytometry.
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