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Biopharmaceuticals process monitoring based on infrared spectroscopy according to quality by design

dc.contributor.authorSales, Kevin
dc.contributor.authorRibeiro Da Cunha, Bernardo
dc.contributor.authorCalado, Cecília
dc.date.accessioned2017-11-15T10:10:38Z
dc.date.available2017-11-15T10:10:38Z
dc.date.issued2017-03-30
dc.description.abstractEscherichia coli, the most common host microorganism to produce high value biopharmaceuticals, presents, however a natural variability due to high sensitivity towards small fluctuations of the cultivation environment. Therefore, to speed up the development process and to control this critical manufacturing step it is relevant to develop monitoring techniques allowing simultaneous characterization of the heterologous product synthesis and of the physiologic cell behavior under a variety of culture conditions. In the present work high-throughput mid-infrared (MIR) spectral analysis of dehydrated E. coli cell pellets and in situ near infrared (NIR) spectral analysis of the whole culture broth were compared to monitor the bioproduction of a model plasmid along recombinant Escherichia coli cultures. Good partial least square regression models were built, either based on MIR or on NIR spectral data. Besides being conducted in situ, NIR spectroscopy allowed building regression models as accurate as those obtained from the MIR setup, and even better models for estimating biomass and glycerol. However, MIR spectroscopy allows retrieving valuable biochemical and metabolic information along the cell culture, e.g. lipids, RNA, protein synthesis and turnover metabolism. This information contributed to better understand the complex interrelationships between the recombinant cell metabolism and the bioprocess environment. In resume, since NIR spectroscopy enables the in situ and real time monitoring without the risk of culture contamination, thus represents an appealing tool for control purposes specially at industrial (i.e. large-scale) productions. On the other hand, MIR spectroscopy is better suited for optimization processes, as it enables the analysis of hundreds of samples at ounce, and to acquire off line historical information along industrial production processes. Both monitoring techniques are therefore complementary, empowering optimization and control procedures more efficiently and quicker, according to the new regulatory framework based on Quality by Design.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationSALES, Kevin; CUNHA, Bernardo R.; CALADO, Cecília R. C. – Biopharmaceuticals process monitoring based on infrared spectroscopy according to quality by design. In 5th Portuguese Meeting on Bioengineering (ENBENG). Coimbra, Portugal. IEEE, 2017. ISBN 978-1-5090-4802-1. Pp. 1-4pt_PT
dc.identifier.doi10.1109/ENBENG.2017.7889460pt_PT
dc.identifier.isbn978-1-5090-4801-4
dc.identifier.isbn978-1-5090-4802-1
dc.identifier.urihttp://hdl.handle.net/10400.21/7509
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherInstitute of Electrical and Electronics Engineerspt_PT
dc.relation.publisherversionhttp://ieeexplore.ieee.org/stamp/stamp.jsp?arnumber=7889460pt_PT
dc.subjectSpectroscopypt_PT
dc.subjectBiomasspt_PT
dc.subjectBiochemistrypt_PT
dc.subjectSugarpt_PT
dc.subjectMonitoringpt_PT
dc.subjectOptical fiberspt_PT
dc.titleBiopharmaceuticals process monitoring based on infrared spectroscopy according to quality by designpt_PT
dc.typeconference object
dspace.entity.typePublication
oaire.citation.conferencePlaceCoimbra, Portugalpt_PT
oaire.citation.endPage4
oaire.citation.startPage1
oaire.citation.title5th Portuguese Meeting on Bioengineering (ENBENG)pt_PT
person.familyNameRibeiro da Cunha
person.familyNameCalado
person.givenNameBernardo
person.givenNameCecília
person.identifier130332
person.identifier.ciencia-idEA1E-4BEA-A01E
person.identifier.ciencia-id9418-E320-3177
person.identifier.orcid0000-0002-0303-9416
person.identifier.orcid0000-0002-5264-9755
person.identifier.ridP-6154-2017
person.identifier.ridE-2102-2014
person.identifier.scopus-author-id57211629814
person.identifier.scopus-author-id6603163260
rcaap.rightsclosedAccesspt_PT
rcaap.typeconferenceObjectpt_PT
relation.isAuthorOfPublication810fc4c7-6c05-44a0-81e5-6cfdb3c2088a
relation.isAuthorOfPublicatione8577257-c64c-4481-9b2b-940fedb360cc
relation.isAuthorOfPublication.latestForDiscovery810fc4c7-6c05-44a0-81e5-6cfdb3c2088a

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