Platform process will give platform product - Can we afford it?

Case 1: The use of platform process enabled accelerated PD from cell culture perspective. However, accommodating the specific PQ requirements resulted in extended process development, affecting timelines. Case 2: Change in clone selection criteria was observed to significantly impact culture performance while applying platform process. This almost resulted in rejection of these clones, thus extending PD timelines. This was prevented by modifying the platform process. Case 3: Clones developed using different cloning technologies when run with the platform process resulted in different cell culture and PQ profiles. Therefore, the type of cloning technique forms an integral part of the platform process. Though platform process was not suitable in most of the cases discussed here, it still offers advantages like expedited project timelines and established work flows. These benefits were achieved by establishing four versions of the platform process to meet the varied cell culture and PQ requirements. Based on the cell line characteristics and target PQ profiles, the appropriate version is chosen to initiate PD. These versions retained the major advantages of the platform process such as having common media and feeds with only changes in their concentrations and set point of main process parameters to achieve desired PQ.