There is a growing interest within the biopharmaceutical industry in adopting continuous processing in place of current batch processing for biological molecules and primarily monoclonal antibodies (mAbs). Expectations from this transition are multiple including reduced product cost of goods, capital expenses and facility foot print while process productivity and flexibility is increased. But the adoption of continuous bioprocessing requires first to achieve a smooth transition for each process step from batch to continuous. The clarification is a key early step within the process which poses the challenge of reducing the cost and foot print of filtration in the context of a continuous mAb purification process. In this study we developed a complete disposable clarification solution combining a disruptive 3D acoustic wave separation technique as primary clarification step followed by high performance depth and sterile filters. This integrated and fully disposable clarification train allows for up to 10 fold reduction in the filtration area when used with 5 to 20L CHO fed-batch cell culture bioreactor with cell density up to 25.10^6 cells/mL and 70 to &gt;90% cell viability. The quality of the CHO clarified material, measured in term of mAb yield of recovery and HCP/DNA/aggregate content, was kept similar to that of the one obtained from a standard batch clarification process. Process modeling and process economic studies show the clarification train is fully scalable and can be implemented in a continuous downstream bioprocess using up to 2000L single use fed-batch bioreactors.

Development of a high performance integrated and disposable clarification solution for continuous bioprocessing

251st National Meeting (2016)

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