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Integrated continuo...
Integrated continuous biomanufacturing on pilot scale for acid-sensitive monoclonal antibodies
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- Schwarz, Hubert (author)
- KTH Royal Institute of Technology,KTH,Industriell bioteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO
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- Gomis-Fons, Joaquín (author)
- KTH Royal Institute of Technology,Lund University,Lunds universitet,Avdelningen för kemiteknik,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Chemical Engineering,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
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- Isaksson, Madelène (author)
- KTH Royal Institute of Technology,Lund University,Lunds universitet,Avdelningen för kemiteknik,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Chemical Engineering,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
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- Scheffel, Julia (author)
- KTH Royal Institute of Technology,KTH,Proteinteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO
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- Andersson, Niklas (author)
- Lund University,Lunds universitet,Avdelningen för kemiteknik,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Chemical Engineering,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
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- Andersson, Andreas (author)
- KTH Royal Institute of Technology,Cytiva, Sweden
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- Castan, Andreas (author)
- KTH Royal Institute of Technology,Cytiva, Sweden
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- Solbrand, Anita (author)
- KTH Royal Institute of Technology,Cytiva, Sweden
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- Hober, Sophia, Professor, 1965- (author)
- KTH Royal Institute of Technology,KTH,Proteinteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO
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- Nilsson, Bernt (author)
- KTH Royal Institute of Technology,Lund University,Lunds universitet,Avdelningen för kemiteknik,Institutionen för processteknik och tillämpad biovetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Division of Chemical Engineering,Department of Process and Life Science Engineering,Departments at LTH,Faculty of Engineering, LTH
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- Chotteau, Veronique (author)
- KTH Royal Institute of Technology,KTH,Industriell bioteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO
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(creator_code:org_t)
- 2022-05-07
- 2022
- English.
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In: Biotechnology and Bioengineering. - : Wiley. - 0006-3592 .- 1097-0290.
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https://doi.org/10.1...
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Abstract
Subject headings
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- In this study, we demonstrated the first, to our knowledge, integrated continuous bioprocess (ICB) designed for the production of acid-sensitive monoclonal antibodies, prone to aggregate at low pH, on pilot scale. A high cell density perfusion culture, stably maintained at 100 × 106 cells/ml, was integrated with the downstream process, consisting of a capture step with the recently developed Protein A ligand, ZCa; a solvent/detergent-based virus inactivation; and two ion-exchange chromatography steps. The use of a mild pH in the downstream process makes this ICB suitable for the purification of acid-sensitive monoclonal antibodies. Integration and automation of the downstream process were achieved using the Orbit software, and the same equipment and control system were used in initial small-scale trials and the pilot-scale downstream process. High recovery yields of around 90% and a productivity close to 1 g purified antibody/L/day were achieved, with a stable glycosylation pattern and efficient removal of impurities, such as host cell proteins and DNA. Finally, negligible levels of antibody aggregates were detected owing to the mild conditions used throughout the process. The present work paves the way for future industrial-scale integrated continuous biomanufacturing of all types of antibodies, regardless of acid stability.
Subject headings
- TEKNIK OCH TEKNOLOGIER -- Industriell bioteknik -- Bioprocessteknik (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Industrial Biotechnology -- Bioprocess Technology (hsv//eng)
- TEKNIK OCH TEKNOLOGIER -- Industriell bioteknik -- Annan industriell bioteknik (hsv//swe)
- ENGINEERING AND TECHNOLOGY -- Industrial Biotechnology -- Other Industrial Biotechnology (hsv//eng)
Keyword
- Chinese Hamster Ovary cells
- ZCa ligand
- antibody aggregation
- antibody manufacturing
- continuous chromatography
- integrated continuous bioprocess
- perfusion culture
- Bioteknologi
- Biotechnology
- antibody aggregation
- antibody manufacturing
- Chinese Hamster Ovary cells
- continuous chromatography
- integrated continuous bioprocess
- perfusion culture
- Z ligand
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Schwarz, Hubert
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Gomis-Fons, Joaq ...
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Isaksson, Madelè ...
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Scheffel, Julia
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Andersson, Nikla ...
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Andersson, Andre ...
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show more...
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Castan, Andreas
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Solbrand, Anita
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Hober, Sophia, P ...
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Nilsson, Bernt
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Chotteau, Veroni ...
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- About the subject
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- ENGINEERING AND TECHNOLOGY
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ENGINEERING AND ...
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- ENGINEERING AND TECHNOLOGY
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ENGINEERING AND ...
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and Industrial Biote ...
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and Other Industrial ...
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Biotechnology an ...
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Royal Institute of Technology
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Lund University