Expression and Characterization of a Trastuzumab-Interferon Fusion Protein in Nicotiana benthamiana to include in vitro Assay Results

摘要

1. Two MS methods have been developed for identification and characterization of the trastuzumab-INF conjugate protein. 2. Product certifications were generated after performing analyses consistent with FDA-sanctioned release assays for drugs. 3. Efficacy was determined relative to the innovator's trastuzumab molecule, Herceptin which is known to inhibit HER2-mediated signaling and induce antibody-dependent cellular cytotoxicity (ADCC).