Complex Fitness Diagrams: Downstream Processing of Biologicals

Abstract

Our concern here is developing successful new production-scale processes and specifically with modifying optimized laboratory procedures that are unsuitable for large-scale operations. We also wish to suggest that speed and economy of development can often be increased quite significantly by judicious incorporation of heuristics. This in turn requires choosing an example, and ours is downstream processing: isolation and purification of high-value fermentation produced biologicals such as therapeutic proteins. We show that one is rapidly led by this kind of thinking to radical but what appear to be highly beneficial changes in production level downstream processing.

Keywords:

• chromatography
• counterflow
• downstream processing
• fitness diagrams
• heuristics
• orders of magnitude
• scale-up