Optimal process mode selection for clone screening

A significant amount of data is generated during clone screening procedures because several cultivation systems are used such as well-plates, shake-flasks, laboratory-scale bioreactors among others. The amount of data can often be staggering and thus requires the use of statistical and data mining procedures in order to extract hidden information. In regard to a biosimilar monoclonal antibody project, data from the shake-flask scale was observed when comparing batch and fed-batch processes for several individual clones derived from two different cell lines. The aim of the research presented in this paper was to determine if clone selection based on batch data during the initial screening phase was equivalent to the results from fed-batch selection. It was determined that fed-batch processes should be implemented early during the screening procedure, if a choice is made that the final manufacturing process should also be operated in a fed-batch mode, as clone selection based on both batch and fed-batch analytical data was divergent.