The development, optimization and validation of an ELISA bioanalytical method for the determination of Cetuximab in human serum

Abstract

Cetuximab is a chimeric IgG1 monoclonal antibody that inhibits epidermal growth factor receptor (EGFR). Additionally, Cetuximab, used in combination therapy, potentiates the effects of chemotherapy and radiation therapy in eradicating well-established tumors. Recently, a combination of Cetuximab and newly developed chemotherapeutic candidate drugs is being investigated for use as a new-generation chemotherapy cocktail. Therefore, there is an increasing need for a highly selective immunoassay to detect Cetuximab at low concentration levels in human serum. We report a newly developed ELISA that is validated under FDA-GLP regulations for the detection of Cetuximab. It is highly selective and achieves a lower limit of quantitation of 0.31 µg/mL. We have validated a selective and sensitive bioanalytical method.