The first step in monoclonal antibody (mAb) downstream processes is to separate the solid cellular debris from the mAb-containing liquid. Traditionally, this has been conducted using a disc stack centrifuge and/or microporous filters. Recent improvements in the cell culture processes have led to higher content of cellular debris which has challenged both centrifugation and microporous membrane filtration techniques.One alternative clarification technique is to use flocculation followed by gravity settling. The efficiency of this technique is sensitive to the flocculation operating parameters and the cell culture material. This makes it challenging to develop, scale-up, and scale-down this new unit operation. In this work we will discuss: (1) methodologies for studying a flocculation and gravity settling process at the bench scale; (2) application of this methodology to studying the effect of cell culture process changes and the flocculation operating parameters on performance; (3) scale-up and scale-down of the flocculation process.

Exploring flocculation as an alternative harvest technique for high density mammalian cell culture processes

245th National Meeting (2013)

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