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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Economics of Scheduling, De-bottlenecking, and Cycle Time

    Abstract

    This chapter provides some simple techniques for estimating the economic performance of biopharmaceutical facilities. Simulation and scheduling software are recommended when greater detail is needed. In most cases, both facility and material costs need to be considered in biopharmaceutical processes. High facility related costs tend to dictate higher production rates, while high material costs tend to dictate minimal product loss. The overall risk of product loss may be estimated from the overall yield and individual per-batch failure rate. Estimating the overall production rate entails determination of the rate-limiting step or process bottleneck. An accurate determination of the process bottleneck requires a detailed analysis of both the process, support utilities and support processes, such as buffer and media preparation.

    About the Authors

    Charles A. Siletti, Intelligen, Inc., Scotch Plains, NJ 07076, USA
    Mr. Siletti received his doctorate from MIT where his research involved the design of protein purification processes. He has spent over 15 years working with computer systems for optimization and automation. His experience includes both biotech and traditional chemical processing. Currently Mr. Siletti is the Director of Planning and Scheduling applications at Intelligen, Inc.

    Demetri Petrides Intelligen, Inc., Scotch Plains, NJ 07076, USA
    Dr. Petrides is the president of Intelligen, Inc., a software company that develops and markets simulation, design, and scheduling tools for a wide variety of industries. He has extensive experience in modeling and optimizing biochemical, pharmaceutical, specialty chemical, and related processes. Dr. Petrides holds a B.S. from National Technical Univ. of Athens (Greece) and a Ph.D. from MIT, both in chemical engineering.


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