Platform Validation of Dissolved Oxygen Ranges for Cell Culture Processes

Process understanding gained through use of a platform process for multiple, similar, products can be leveraged to further streamline the development, characterization and validation of new processes based on the platform. Genentech has developed and commercialized several therapeutic monoclonal antibody (mAb) products using Chinese Hamster Ovary (CHO) cell cultures in a standardized fed-batch culture. A strategy for implementing platform validation of dissolved oxygen ranges has been developed for new processes when they are sufficiently similar to the platform process. A platform validation data set was developed from characterization studies of several antibody processes demonstrating that a consistent set of dissolved oxygen ranges do not significantly impact cell culture metrics or mAb quality attributes. These ranges are applicable to new products when the cell culture processes are sufficiently similar to the platform process, and the mAb quality attributes are included in the platform validation data set.