JSL to the Rescue: Coping Strategies for Making Sense of Real-Time Production Data in Vaccine Manufacturing

Andrea Coombs, MS, Operations Research Analyst – Emergent BioSolutions

Emergent BioSolutions Inc. is a biopharmaceutical company that manufactures BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  BioThrax® production includes a two-stage fermentation of a non-virulent strain of Bacillus anthracis.  In-line turbidity, temperature, and pH probes are used to monitor the fermentation process and real-time data can be viewed remotely and is available for analysis.  JMP has been used to create a customized workflow to summarize data from multiple production trains.   A “super” journal is the command central of this customized workflow that contains JSL scripts to access, process, track and analyze data.  Central to this workflow are scripts to process real-time data into meaningful variables critical to the process, verify variables to ensure accuracy, and dynamic handling and visualization of data.  As a result, an overwhelming amount of real-time production data has been summarized into the key variables that have been used to monitor, characterize and improve the fermentation process.