Platform Technology To Speed Up CMC Process - Seguridad Mania.com - España y América Latina

The commercial success of monoclonal antibodies has made biologics become attractive to pharmaceutical companies . The approval pathway is often required to extensive chemistry, manufacturing and control (CMC) study to ensure the long‐term safety and efficacy of biologics. However, the CMC studies remains labor intensive and time consuming. Reduction of CMC time has become one of the most important technological advantages for a biological therapeutic developer. Therefore, the ability to develop a biologically active molecule at the short duration via cell culture platform has become the key of successful biologic development. The priority of biologic companies is to acquire and develop cell culture technology platforms that enable them to speed up their CMC process; and to reach clinical trials quickly. Hence, we will discuss current cell culture technologies that are relevant to CMC development.