Monday, July 30, 2007
P34

Concept to Prototype: A Bioreactor Controller and Data Management System Designed to Fit the Needs of a Cell Culture and Fermentation Process Development Laboratory

Deniz Turan-Koteen and Nicole Bleckwenn. Process Cell Culture and Fermentation / Development, MedImmune, Inc., One Medimmune Way, Gaithersburg, MD 20878

Small scale experimentation, data collection and analysis are key functions in biopharmaceutical process development laboratories. For this poster, progression of a custom designed SCADA (Supervisory Control and Data Acquisition) system is presented. The timeline in consideration begins with the conceptualization stage and flows through to the testing of the prototype by running an established cell culture process. Although this project required the contribution of several departments, specifically technical design and user-related details of the system are emphasized here.

This SCADA system is primarily designed to control 3L bench-scale bioreactors. It also supports up to 100L SIP vessels and smaller scale experiments such as shake flasks, wave-bags and spinner flasks by collecting and analyzing offline data. A multitude of tools are integrated to control the operation either manually or using detailed recipe instructions. The system collects offline results from analytical instruments, in addition to monitoring real-time data. In-built future expansion capability to enable PAT based sensor technologies is another part of this custom design. The traceability of information via audit trails and change control characteristics give us proper documentation capability while allowing the user to concentrate on the science rather than data recording. The data management system is also aligned with the full scale production vessels, supporting a complete process development effort from cell line selection through commercial production. With our enhancement of controller technology, this system will considerably reduce the labor involved in operation, data collection, entry, and help the development scientists manipulate the process execution with accuracy and ease.