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The Rise of Biopharmaceutical Contract Manufacturing

By: Thomas C. Ransohoff
Reprinted with permission of BioPharm International, October 2007

Biopharmaceutical products are complex macromolecules that must be manufactured to meet high purity and quality standards. Due to the complexity of biopharmaceutical manufacturing processes and the technically challenging analytical test methods used to characterize these products, biomanufacturing facilities are expensive to build and operate. Added to this complexity is the need to begin construction of a commercial manufacturing facility early in the clinical development of a new biologic product when it is extremely difficult to accurately predict manufacturing capacity requirements. Even against a backdrop of increasing use of outsourcing in the pharmaceutical and other industries, regulatory and technical challenges have created additional obstacles for the outsourcing of biopharmaceutical products. This article reviews the growth in biopharmaceutical contract manufacturing over the last two decades and discusses current industry trends and dynamics resulting from the increasing use of biopharmaceutical contract manufacturing for both clinical and commercial manufacturing.