James E. Seely, PhD


Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration

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.