Passive immunotherapy refers to the transfer of antibodies to an unprotected individual for the treatment or prevention of disease. Polyclonal antibodies isolated from convalescent serum have been successfully used as passive immunotherapies for many years. Monoclonal antibodies (mAbs) offer several advantages as passive immunotherapeutic agents since they can be manufactured at large scale with inherently high specificity and consistency. Facing a pandemic infectious disease outbreak, tailored bioanalytical approaches should be swiftly developed to support accelerated clinical trials. This presentation will summarize our efforts in developing a hybrid LC-MRM workflow for the quantitation of mAbs used as passive immunotherapeutic agents of viral infections. The workflow is generic and does not rely on highly specific critical reagents. More importantly, it offers the potential for multiplexing should a combination of different antiviral mAbs be dosed simultaneously. Key considerations for method development and case scenarios will be discussed.
Understand how mass spectrometry can be used for the quantitation of passive immunotherapeutic agents
Identify key parameters for the development of robust hybrid LC-MRM assays
Obtain general knowledge and understanding of passive immunotherapy