Quality by design (QbD) approach to SE-HPLC method development for cetuximab Monoclonal antibodies

value exceeding 0.999. The method's limits of detection and quantitation were determined and found to be satisfactory, with robust accuracy and precision. Under thermal stress conditions (50 °C for 1 hour), the presence of degradation products did not interfere with the detection of HMWP and monomers, confirming the method's stability-indicating capability. The forced degradation study revealed an increase in HMWP content, demonstrating the method's ability to effectively separate and quantify degradation products. This developed SE-HPLC method offers advantages over previously published methods through its systematic Quality by design (QbD)-based development, comprehensive design space definition, and enhanced robustness demonstrated through the Method Operable Design Region (MODR), making it suitable for quality control quantification of HMWP and monomers in Cetuximab, as well as for stability studies.