ISSN: 2574-187X
Authors: Vijay P Pattar, Nagappa L Teradal and Sharanappa T Nandibewoor*
EphA2-ILs-DTX-DEAB is an antibody directed nanoparticle (ADN) that targets Ephrin receptor A2 (EphA2) with a specific single-chain variable fragment (scFv) conjugated to the surface of the liposome. It entered Phase I clinical trials in March 2017 for the treatment of patients with various solid tumors. We subjected the drug product EphA2-ILs-DTX-DEAB and the drug substance DTX-DEAB to acid/base stress testing conditions and identified major degradation products by comparing them to reference standards. There were significant differences in degradation profiles of the free drug vs an encapsulated drug. A greater degree of acid degradation was observed for EphA2-ILs-DTX-DEAB compared with free DTX-DEAB, indicating the influence of drug microenvironment on overall chemical stability.
Keywords: