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Commentary on Capacity Requirements for Biopharmaceuticals – The Shortage That Never Was

By: Thomas C. Ransohoff and Howard L. Levine, Ph.D. BioProcess Technology Consultants, Inc.
Reprinted with permission of Bioprocess News D&MD Publications, March 2003

Much has been written over the past couple of years regarding an apparent lack of manufacturing capacity to meet the growing demand for biologic products, particularly monoclonal antibodies and antibody-based products. To better understand the state of the supply and demand for manufacturing capacity for these products, we have carefully analyzed the pipeline for biotherapeutic products and the current and future manufacturing capacity to produce these products. Our analysis suggests that as a result of recent and ongoing facility expansions, the number of companies having very large scale capacity is increasing so that the distribution of capacity within the industry is becoming much broader. This increase in total industry capacity, accompanied by a general increase in bioreactor utilization and overall yields, suggests that supply for manufacturing capacity will be roughly equal to demand and the severe capacity shortages predicted by many are unlikely to materialize.