Using Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development

With the ever increasing cost of developing biopharmaceuticals and number of drug candidates in the R&D portfolio, more efficient systems are required to progress molecules quickly through the R&D pipeline into clinical development and commercial launch. Over the past decade, MedImmune has developed expertise to express monoclonal antibodies at titers greater than 10 g/L at manufacturing scale and has leveraged these advances into the design of our platform processes. In addition to platform cell culture processes that yield high titers, the implementation of high-throughput bioreactor systems, including ambr (by TAP Biosystems), has been instrumental in efficiently defining a commercially-viable process early on with minimal resources. In this work, we demonstrate how we have leveraged these tools for (1) accelerating clone selection, (2) Phase 1 clinical trial and commercial process design, and (3) scale-down model definition suitable for design space, QbD, or other BLA-enabling activities.