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Integrated continuo...
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Schwarz, HubertKTH Royal Institute of Technology,KTH,Industriell bioteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO
(author)
Integrated continuous biomanufacturing on pilot scale for acid-sensitive monoclonal antibodies
- Article/chapterEnglish2022
Publisher, publication year, extent ...
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2022-05-07
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Wiley,2022
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:kth-309567
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https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-309567URI
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https://doi.org/10.1002/bit.28120DOI
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https://lup.lub.lu.se/record/612906a2-8803-4ad4-8b77-64855c930d52URI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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QC 20220523
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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.
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Gomis-Fons, JoaquínKTH 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(Swepub:lu)jo3084go
(author)
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Isaksson, MadelèneKTH 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(Swepub:lu)ma3235is
(author)
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Scheffel, JuliaKTH Royal Institute of Technology,KTH,Proteinteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO(Swepub:kth)u1y97f4h
(author)
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Andersson, NiklasLund 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(Swepub:lu)chem-nao
(author)
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Andersson, AndreasKTH Royal Institute of Technology,Cytiva, Sweden
(author)
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Castan, AndreasKTH Royal Institute of Technology,Cytiva, Sweden
(author)
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Solbrand, AnitaKTH Royal Institute of Technology,Cytiva, Sweden
(author)
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Hober, Sophia,Professor,1965-KTH Royal Institute of Technology,KTH,Proteinteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO(Swepub:kth)u11qqzc1
(author)
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Nilsson, BerntKTH 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(Swepub:lu)kat-bni
(author)
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Chotteau, VeroniqueKTH Royal Institute of Technology,KTH,Industriell bioteknologi,Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO(Swepub:kth)u1gyk88o
(author)
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KTHIndustriell bioteknologi
(creator_code:org_t)
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In:Biotechnology and Bioengineering: Wiley0006-35921097-0290
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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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Castan, Andreas
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