While Culture does not run bioreactors at scale, Culture can help customers develop processes that are well-suited for scale-up. Customers have successfully scaled from Culture’s bioreactors to various volumes, as large as 50,000L.
Well-characterized bioreactor systems
Culture has performed detailed characterizations of their bioreactors. This allows for appropriate bounds to be placed on process parameters, such as OTRs, in order to ensure processes are developed in a manner that will be scalable.
Culture’s capacity allows for a breadth of de-risking studies to be performed. While all the risks of scale-up cannot be eliminated, a number of risk areas can be tested utilizing Culture’s bioreactor capacity to understand potential factors that may impact performance. These include simulations of process conditions at scale and testing scalable media components from different vendors and lots.
For more on scaling up a bioprocess, including key challenges to keep in mind and best practices: