Current evolution to high cell density and high product titer monoclonal antibody CHO cell cultures is placing a larger burden on traditional downstream clarification and purification operations.To alleviate this challenge, various types of pre-treatments are being employed to make the clarification process more efficient. Pre-treatment is accomplished either through the reduction in pH of the feedstream (acid precipitation) or through the addition of cationic polymers (flocculation). These methods result in aggregation of solid and soluble particle impurities into larger agglomerates, thus reducing small particles which are difficult to centrifuge and can plug downstream filters. In this study we implement and demonstrate the benefits of combining high CHO cell density harvest with acid pre-treatment followed by Clarisolve® depth filters. Clarisolve® depth filters are specifically designed to handle very large particles sizes. Alternatively, Millistak+® depth filters were assessed without any harvest pre-treatment. The results show that acidic pre-treatment followed by Clarisolve® depth filter enhanced primary depth filtration performance as compared to traditional calrification with no pre-treatment. Also this method was able to reduce impurities in filtrate significantly to make less loading on further downstream processing.

High CHO cell density harvest clarification: Acidic pre-treatment followed by Clarisolve® depth filters exhibits multiple benefits such as filtration area reduction and filtrate quality improvement

ACS Fall 2021

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