A promising biotech start-up with drug candidates progressing from Stage 2 to Stage 3 clinical, with limited automation staffing, turned to Banks Integration to help with their transition to full scale manufacturing. At this crucial time, collection of data to be used in their license application and a transition from laboratory protocol to full cGMP manufacture is critical.

The plant selected for production of clinical material and initial launch has islands of automation that often predate 21 CFR part 11 requirements from numerous OEM manufacturers that were not designed to be integrated into a plant network. Some of the equipment did not even have Ethernet connectivity.

Through a collaborative effort Banks designed a highly scalable system for the biotech client by starting small to fit into their budget yet one that can be expanded to a large multi-site manufacturing network when the drugs are approved. Although the new Data Historian system is currently licensed for only 3000 tags, the underlying infrastructure is designed so that the system can expand to 100,000 tags with only license upgrades and integration of the new tags and systems.

Because of the diverse disparate OEM systems in the plant, OSIsoft’s PI was chosen as the plant historian as it has documented success for integrating the required systems. For the cGMP HMI plant SCADA system backbone, Rockwell’s Factory Talk View Site Edition (ViewSE) was chosen because of the installed base of Rockwell controlled equipment in the plant and the migration path of PanelView HMIs to a 21 CFR Part 11 compliant system.