Do you have to do much optimization on your perfusion culture?

Answer

For products (e.g.,monoclonal antibodies) that in general tend to behave similarly in production we typically do minimal process development work for early stage programs (e.g., prior to IND or for production of Phase I/II clinical trial material) but rather we leverage our well-established continuous “platform” process.  For example, our platform comprises solid knowledge of our host cell line, media (in combination with the host cell line) and process control strategies. In addition, we know that the pre-characterized scale-down model process we use in development can usually be directly scaled up to clinical manufacturing scale thus minimizing the tech transfer efforts. Perfusion cell culture development could be costly and resource demanding so developing a platform process to streamline work for all future products is ideal. Of course there are needs for extensive process optimization in some cases, such as production of challenging molecules (e.g., unstable molecules), developing processes for biosimilars with strict quality requirements or for products entering later stage process development where the goal of reducing production costs and/or establishing more enhanced process robustness is critical. However, it should be noted that these same aforementioned process optimization requirements may also be required for fed-batch processes.