Monoclonal antibody expression levels have been improved significantly through continuous development efforts in cell line, media and operation mode of cell culture processes. As a result, conventional clarification technologies have been seriously challenged in their capability to clarify feed stocks for downstream operation.In this presentation, different flocculation techniques will be presented that improve the clarification efficiency and provide additional benefits in impurity reductions, thus enabling potentially more streamlined downstream processes without negatively affecting the product quality.  Harvest process performance with multiple flocculants was evaluated at pilot scale using multiple monoclonal antibody molecules.The ultimate goal is to overcome the disk-stack centrifuge solid handling limitation, improve the depth filtration and polishing filtration performance and eventually perform the entire harvest operation using disposable equipment.

Developing recovery clarification processes for mammalian cell culture with high density and high solid content

243rd National Meeting (2012)

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