(787d) Application of Process Monitoring Data Management Systems to Make Multiple Incremental Improvements to Cell Cultures Processes at the Manufacturing Scale
AIChE Annual Meeting
2016
2016 AIChE Annual Meeting
Food, Pharmaceutical & Bioengineering Division
Innovations in Biopharmaceutical Discovery, Development, and Manufacturing II
Friday, November 18, 2016 - 4:21pm to 4:43pm
We explore the use of this database to make several incremental improvements to the cell culture process through a series of case studies including responses to health authority requests, technology transfers between multiple facilities, and evaluations of upstream parameters to understand their impact on final drug substance output. These case studies highlight the gains in process knowledge that can be achieved using these data management tools and illustrate some of the challenges in developing these capabilities. While data management tools facilitated the rapid retrieval of available data, there were several obstacles associated with data structure, data acquisition, and the subsequent data analysis. The current work demonstrates the successful application of data management tools to improve the performance and robustness of existing cell culture processes at the manufacturing scale.