Concentration of clarified pool by single‐pass tangential flow filtration to improve productivity of protein A capture step: Impact of clarification strategies
Protein A capture chromatography remains a high‐cost and relatively low‐productivity step for downstream processing of monoclonal antibodies. As bioprocessing transitions toward intensified processes, maximizing the efficiency of individual steps is key to achieving economic targets. This study was...
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| Veröffentlicht in: | Biotechnology and bioengineering 2024-03, Vol.121 (3), p.1090-1101 |
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| container_title | Biotechnology and bioengineering |
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| creator | Rahane, Santosh B. Gupta, Akshat Szymanski, Philip Kinzlmaier, Dana McGee, Patrick Goodrich, Elizabeth |
| description | Protein A capture chromatography remains a high‐cost and relatively low‐productivity step for downstream processing of monoclonal antibodies. As bioprocessing transitions toward intensified processes, maximizing the efficiency of individual steps is key to achieving economic targets. This study was performed to assess the impact of inline concentration of clarified cell culture fluid (CCF), using single‐pass tangential flow filtration, on protein A chromatography purification productivity. CCF with varying levels of impurities and turbidity were obtained dependent upon the clarification method. These CCFs were concentrated and processed over a protein A capture step. Productivity increases of 1.8‐ to 2.6‐fold were achieved as compared to a protein A capture step with no CCF concentration. Achieving such targeted improvements requires careful consideration of the multiple components in the clarification strategy before implementation. |
| doi_str_mv | 10.1002/bit.28634 |
| format | Article |
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As bioprocessing transitions toward intensified processes, maximizing the efficiency of individual steps is key to achieving economic targets. This study was performed to assess the impact of inline concentration of clarified cell culture fluid (CCF), using single‐pass tangential flow filtration, on protein A chromatography purification productivity. CCF with varying levels of impurities and turbidity were obtained dependent upon the clarification method. These CCFs were concentrated and processed over a protein A capture step. Productivity increases of 1.8‐ to 2.6‐fold were achieved as compared to a protein A capture step with no CCF concentration. Achieving such targeted improvements requires careful consideration of the multiple components in the clarification strategy before implementation.</description><identifier>ISSN: 0006-3592</identifier><identifier>EISSN: 1097-0290</identifier><identifier>DOI: 10.1002/bit.28634</identifier><identifier>PMID: 38151902</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Animals ; Antibodies, Monoclonal - chemistry ; Bioprocessing ; Cell culture ; Cell Culture Techniques - methods ; CHO Cells ; Chromatography ; clarification ; Cricetinae ; Cricetulus ; Filtration ; Filtration - methods ; flocculation and precipitation ; harvest concentration ; Impact analysis ; Impurities ; Monoclonal antibodies ; process intensification ; Productivity ; Protein A ; protein A capture productivity ; Protein folding ; Protein purification ; Proteins ; single‐pass tangential flow filtration ; Staphylococcal Protein A - chemistry ; Turbidity</subject><ispartof>Biotechnology and bioengineering, 2024-03, Vol.121 (3), p.1090-1101</ispartof><rights>2023 Wiley Periodicals LLC.</rights><rights>2023. 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| subjects | Animals Antibodies, Monoclonal - chemistry Bioprocessing Cell culture Cell Culture Techniques - methods CHO Cells Chromatography clarification Cricetinae Cricetulus Filtration Filtration - methods flocculation and precipitation harvest concentration Impact analysis Impurities Monoclonal antibodies process intensification Productivity Protein A protein A capture productivity Protein folding Protein purification Proteins single‐pass tangential flow filtration Staphylococcal Protein A - chemistry Turbidity |
| title | Concentration of clarified pool by single‐pass tangential flow filtration to improve productivity of protein A capture step: Impact of clarification strategies |
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