Articles by Dave Smiley - BioPharm International

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Articles by Dave Smiley

Dave Smiley


Articles
Scaling Down of Biopharmaceutical Unit Operations — Part 2: Chromatography and Filtration
April 1, 2005

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.

Scaling Down of Biopharmaceutical Unit Operations — Part 1: Fermentation
March 1, 2005

Lot-to-lot variations between raw materials can greatly impact process performance.

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