White Paper

Managing Risks Within Platform Processes Through Media Components

Source: SAFC

A platform process is a set of standardized protocols and reagents that can be used to support a variety of clinical molecules. Typically these protocols and reagents, including cell culture media and feeds, are standardized for a specific parental cell line such as CHO or NSO, and cell culture process, like batch, fed-batch or perfusion. Platform processes prove advantageous when it comes to implementing developmental improvements. An enhancement to the platform can be spread across multiple clinical molecules, improving an organization's return on investment. However, if there is a problem with a reagent in a platform process, it has the potential to impact multiple molecules in the organization's clinical pipeline. A number of risks are inherent to platform processes. They fall into three main areas: supplier risk, raw materials risk, and process risk.