P42: Development of an E .coli Recombinant Protein Fermentation Process

In the late stage clinical development of an Escherichia coli (E. coli) clinical recombinant protein fermentation process, changes to the host strain, production plasmid and glucose feeding strategy were implemented to increase product titer, maintain product quality and improve process consistency. The optimized fermentation process was developed using a small scale model where increased product titer and consistent product quality were achieved. Process understanding was expanded by the execution of univariate and multivariate studies. The fermentation process was successfully transferred to manufacturing scale while maintaining the high product titer, product quality consistency and fermentation process performance.