Establishing an efficient drug development and manufacturing process has always been paramount in the biopharmaceutical industry. With the surge in antibody development, the arrival of advanced modalities, and the rise in complexities posed by a global crisis, drug developers are feeling even more pressure to meet stringent regulatory and commercial launch timelines. Though there are many factors that can challenge a drug candidate’s progress, one of the most critical is managing the sourcing, supply, and manufacturing of cell culture media.
The importance of successfully scaling up cell culture media cannot be overstated. Not starting the process soon enough can introduce issues with solubility, manufacturability, procurement, and cost management. In a worst-case scenario, drug developers are confronted with the fact that their media—though feasible at bench scale—cannot be optimized for large-scale manufacturing, which results in a costly and time-consuming return to the bench for further development work.
There are several common process development and business development inefficiencies that drug developers may encounter in accelerating their cell culture media manufacturing process. Employing media prototyping to identify the most feasible cell culture media for cGMP scale-up is only one part of the equation. There are additional technical and commercial best practices that drug developers must enact so that they, their suppliers and media manufacturers, and in turn, their cell culture media remain on the most efficient path to market.