<div class="csl-bib-body">
<div class="csl-entry">Rathore, A. S., Garcia-Aponte, O. F., Golabgir Anbarani, A., Vallejo-Diaz, B. M., & Herwig, C. (2017). Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals. <i>Pharmaceutical Research</i>. https://doi.org/10.1007/s11095-016-2043-9</div>
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The final publication is available at Springer via <a href="https://doi.org/10.1007/s11095-016-2043-9" target="_blank">https://doi.org/10.1007/s11095-016-2043-9</a>.
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dc.description.abstract
Knowledge Management (KM) is a key enabler for achieving quality in a lifecycle approach for production of biopharmaceuticals. Due to the important role that it plays towards successful implementation of Quality by Design (QbD), an analysis of KM solutions is needed. This work provides a comprehensive review of the interface between KM and QbD-driven biopharmaceutical production systems as perceived by academic as well as industrial viewpoints. A comprehensive set of 356 publications addressing the applications of KM tools to QbD-related tasks were screened and a query to gather industrial inputs from 17 major biopharmaceutical organizations was performed. Three KM tool classes were identified as having high relevance for biopharmaceutical production systems and have been further explored: knowledge indicators, ontologies, and process modeling. A proposed categorization of 16 distinct KM tool classes allowed for the identification of holistic technologies supporting QbD. In addition, the classification allowed for addressing the disparity between industrial and academic expectations regarding the application of KM methodologies. This is a first of a kind attempt and thus we think that this paper would be of considerable interest to those in academia and industry that are engaged in accelerating development and commercialization of biopharmaceuticals.
en
dc.description.sponsorship
Industrial Methods for Process Analytical Chemistry - From Measurement Technologies to Information Systems (imPACts)
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dc.language
Deutsch
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dc.language.iso
de
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dc.publisher
Springer
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dc.relation.ispartof
Pharmaceutical Research
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dc.rights.uri
http://creativecommons.org/licenses/by/4.0/
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dc.subject
knowledge indicators
en
dc.subject
knowledge management
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dc.subject
ontologies
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dc.subject
process modeling
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dc.subject
quality by design
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dc.title
Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals
de
dc.type
Article
en
dc.type
Artikel
de
dc.rights.license
Creative Commons Namensnennung 4.0 International
de
dc.rights.license
Creative Commons Attribution 4.0 International
en
dc.contributor.affiliation
Indian Institute of Technology Delhi, India
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dc.contributor.affiliation
Universidad Nacional de Colombia, Bogotá, Colombia
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dc.relation.grantno
843546
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dcterms.dateSubmitted
2016-05-10
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dc.rights.holder
The Author(s) 2016
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dc.type.category
Review Article
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tuw.journal.peerreviewed
true
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tuw.peerreviewed
true
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tuw.version
vor
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wb.publication.intCoWork
International Co-publication
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dcterms.isPartOf.title
Pharmaceutical Research
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tuw.publication.orgunit
E166 - Institut für Verfahrenstechnik, Umwelttechnik und technische Biowissenschaften