(597f) Improved Process Control Through Advanced Analytics During Media Development

Robust media are critical for the development of biologic molecules to maintain process consistency and control product quality attributes. Recent advances in analytics have provided a deeper understanding of the medium which has led to a more robust composition. Light exposure of the medium has been shown to lead to chemical degradant products which have a negative impact on the cell culture performance, specifically with regards to the specific growth rate and viable cell density.  As previously described[1] , a liquid chromatography-mass spectrometry (LC-MS) was used to characterize multiple lots of media to determine the root cause for poor cell culture performance.  It was shown that the medium that had performance below expectations had an increased level of tryptophan oxidation products and a riboflavin degradant, lumichrome, present.  In this study we evaluated chemically- defined, proprietary media and commercially available medium using multiple cell types to gain a better understanding of the cell culture behavior and the effect of medium.  We evaluated cell culture performance based on viable cell density and viability to determine a robust strategy for media development to ensure high product yields.   Based on the results, we identified a medium formulation that mitigates the risk associated with light exposure of the medium