Biography
Biography: Xi Hu
Abstract
As antibody drug conjugates (ADCs) move through clinical development, from phase 1 to pivotal studies, supported by clinical efficacy and appropriate safety, the development of late stage and commercial-ready processes and methods becomes a priority. During the development of commercial-ready processes, several key activities have contributed to the successful advancement of the inotuzumab ozogamicin program to late-stage development. Among these are the development of a control strategy that focuses on the control of quality attributes from raw materials through drug product, attention to proper scaling of unit operations, detailed understanding of the product through application of appropriate analytical tools, and studies of the effect of process parameters on quality attributes. In addition, planning for the complex supply chain and facility requirements for handling cytotoxic materials has been crucial. This ADC is particularly complex, but the approaches used are applicable universally