Platform processes are integral for the rapid development of new therapeutic molecules within the biopharmaceutical space. Since platform processes are inherently limited in their capacity for change, there are serious strategic questions related to timing and implementation of modifications to a platform. Under discussion are the implications of changing a platform process with a focus on mammalian cell culture development. This includes necessity and timing for the change, the method of exploration of new platform setpoints and conditions, qualification of the platform, and characterization of platform robustness.
A case study is presented regarding application and implementation of a new platform process. Exploratory studies were used to identify incremental improvements to an existing platform. Changes included culture feed and feed timing, gassing conditions, and seed train. When evidence was generated to support use of the new platform, a series of qualification studies on multiple established molecules were conducted to support the use of the new platform. Finally, after the platform was accepted a collection of process robustness studies were performed based on a platform risk analysis. These studies will provide the process knowledge to support a quality by design approach through both early and late stage development.
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum