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The Use of Models to Estimate and Control the Cost of Biopharmaceutical Manufacturing

By: Howard L. Levine, Ph.D., BioProcess Technology Consultants, Inc. and Peter Latham, BioPharm Services, Inc.
Reprinted with permission of BioPharm Int. 2004 Feb; 17(2):46-55

As the biopharmaceutical industry matures and more and more biologic products enter the marketplace, competition, price controls, and dosing have driven product prices down putting increasing pressure on companies to control manufacturing costs. As pressure increases to bring products to market faster and to lower the overall cost of therapeutic products, it has become critical for companies to understand the potential costs of manufacturing a new product, develop economically viable manufacturing processes, develop optimal strategies for manufacturing, and ensure adequate supply of product for the marketplace. These demands have led companies to develop and use a variety of models to analyze and optimize biomanufacturing. In this article, Howard Levine, President of BioProcess Technology Consultants and Peter Latham, President of BioPharm Services, describe some of the most common types of models available for analyzing and evaluating manufacturing processes and operations and discuss when and where each modeling technique should be applied during a product’s life cycle.