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The Impact of the EU Clinical Trials Directive and Other Recent Regulatory Changes on the Manufacture of Biopharmaceuticals

By: Susan Dana Jones and Howard L. Levine
Reprinted with permission of Preclinica, September/October 2004

Recent changes in the regulatory guidelines for biopharmaceutical production in both the United States and Europe have led to unintended consequences on the cost and efficiency of new product development and manufacturing. In the EU, these changes have resulted in a more unified and more rigorous approach to product and process validation while in the US, new FDA policies and regulations now emphasize product specifications as being an inherent component of product characterization rather than defined by the manufacturing process. These differences in regulatory policy between Europe and the US may influence manufacturing strategies for early stage clinical trial material and in the choice of countries, facilities, or contract manufacturing organizations in which to produce clinical trial material for Phase I and Phase II trials.