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Constraints associated with equipment can make scale-down a challenging exercise.
Apr 1, 2005
By:
Anurag S. Rathore, PhD, Raj Krishnan, Stephanie Tozer, Dave Smiley, Steve Rausch, James E. Seely, Ph.D.
Creation and qualification of scale-down models is essential for performing several critical activities that support process validation and commercial manufacturing. This combined article is the fifth in the "Elements of Biopharmaceutical Production" series. Part 1 (March 2005) covered fermentation. In this segment, we present some guidelines and examples for scale-down of common downstream unit operations used in biotech processes — chromatography and filtration.
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