Cell Culture & Upstream Processing
Process Optimization and Scale-Up Challenges in the Development of a Large-Scale Chemically-Defined Phase III/Commercial Manufacturing Cell Culture Process
Developing a Phase III/commercial cell culture process can present challenges including optimizing cell culture conditions for maximized productivity while maintaining product quality consistent with the needs of the clinical development program. Development of a phase III/commercial process will be described for a CHO monoclonal antibody product through process optimization and scale-up. A new chemically-defined medium (CDM) formulation was implemented for this process at large scale for the first time. The use of this CDM formulation resulted in highly consistent cell culture performance at both small scale and pilot scale. However, during scale-up for clinical manufacturing, challenges were identified and investigated. Details of this investigation and the process / operational improvements implemented at large scale for Phase III and qualification runs will be presented.