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Monoclonal Antibody Manufacturing Strategies for the 21st Century

By: James Blackwell, Ph.D., Thomas Ransohoff, and Howard L. Levine, Ph.D.
Reprinted with permission of Pharmaceutical Outsourcing, July|August 2010

One of the greatest challenges facing biopharmaceutical companies is ensuring adequate manufacturing capacity for products that are under development and potentially years away from commercialization. Companies without existing manufacturing capacity must decide among several alternatives, including building internal manufacturing capability, acquiring existing manufacturing facilities, outsourcing production to a contract manufacturing organization (CMO), or combinations of these. We present the strategic and tactical implications of various “make versus buy” strategies and discuss such critical aspects of developing appropriate manufacturing strategies for biopharmaceutical products as capital investment and risk, CMO selection, and the timing and cost of building manufacturing capacity.