Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies

Abstract

Based on experience with multiple molecules, Amgen developed a cell culture platform for process development of monoclonal antibodies and Fc fusion proteins to increase the speed to market and to minimize resource commitment during early phase development. While most parameters are pre-specified, a small subset does require some optimization because of performance differences across molecules and their cell lines. As measured by cell culture performance (titer and scalability) and business metrics, use of the platform has been very successful. A couple of Amgen’s earlier projects, however, did not perform as well as others under the platform conditions. The atypical molecules have required more time and/or resources to meet performance goals and, even then, they did not necessarily achieve the targeted levels. Despite the difficulties, the experience of working with these molecules did provide some information for improving overall platform success at both bench and pilot scales. Periodic updates of the platform by a peer-review process that incorporates “lessons learned” and advances from in-house technology development have resulted in higher titers, greater consistency in performance across Amgen sites, and improved operations in our pilot-scale and clinical manufacturing environments. While intended as an approach for early phase molecules, experience gained over multiple projects has resulted in evolution of the platform that is moving us closer to a single phase of upstream process development.