(204g) Cell Culture and Fermentation Control and Data Management

Comprehensive management systems for cell culture and fermentation processes, leveraging techniques from the electronics industry, are increasing efficiency while reducing risk and time-to-market for leading pharmaceutical laboratories. Laboratories, from small-scale process development labs through high-end production facilities, find that unified and automated control and data management provides increased efficiency and repeatability, accelerating the commercialization of new biotherapeutics.

Combining the lessons learned in the Silicon Valley electronics industry, years of experience in biotechnology and chemical instrumentation, and collaboration with some of the West Coast's major pharmaceutical companies has resulted in a "factory automation" model for the biopharmaceutical industry. Using a networked, scalable system, experiments are designed in researchers' offices, refined in small volumes in R&D labs, perfected in larger Process Development reactors, and can be deployed to the Pilot Plant and manufacturing, with results summarized at every stage for both scientific analysis and business planning.

Important features for cell culture and fermentation control systems include:

· Recipe development for process control · Data acquisition, analysis, display, and archiving · Communication with instruments, regardless of manufacturer · Equal access from anywhere in the networked system · System security and tracking · Industry-standard instrumentation protocols (such as OPC and National Instruments FieldPoint) · Adherence to Good Laboratory Practices · FDA compliance · Supports PAT Initiative · Extension capabilities for a company's own proprietary control algorithms, calculated results, custom data displays, and unique hardware

Benefits of cell culture and fermentation control systems include increased efficiency in process development and analysis of results, leading directly to reduced time-to-market for new products. This translates directly into reduced operation costs and avoidance of lost opportunity costs. In addition, managing process data, control, analysis, and security reduce the chance of expensive, catastrophic loss of experiment data and materials. An additional benefit is the minimization of the cost of expansion for companies that want to unify their facilities and plan for the future. Expansion includes scaling up production, increasing process volumes, adding more bioreactors and other instrumentation, developing new control strategies or analyses, and integrating with other parts of the business enterprise.

Meg Kay, Director of Process Control Products at WireWorks West, will discuss requirements for comprehensive management systems for cell culture and fermentation processes. WireWorks West has provided its FermWorks system and other control and analysis applications to Genentech, Bayer, Stanford Genome Technology Center, BioMarin, Centocor, NexBio, Novozymes, Flextronics, The University of Victoria, and others.