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Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals.

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.

SUBMITTER: Rathore AS

PROVIDER: S-EPMC5236082 | biostudies-other | 2017 Feb

REPOSITORIES: biostudies-other

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Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals.

Rathore Anurag S AS Garcia-Aponte Oscar Fabián OF Golabgir Aydin A Vallejo-Diaz Bibiana Margarita BM Herwig Christoph C

Pharmaceutical research 20161026 2

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 ...[more]

PMID: 27785590

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Project description:ObjectiveTo develop and validate a questionnaire assessing knowledge, attitudes and practices in the dietary management of IBS.Subjects/methodsAn initial pool of 151 questions was generated addressing three domains (knowledge, attitudes, practices). Academic/senior clinical dietitians (n = 5) provided written feedback and a focus group (n = 4 gastroenterology dietitians) was undertaken to evaluate content and face validity of the question-items. Items considered irrelevant were removed and the refined questionnaire was administered to dietitians with different levels of IBS experience (n = 154) for further psychometric testing. Item reduction analysis was assessed by item difficulty index, discrimination index and point-biserial correlation. Construct validity was assessed via principal component analysis (PCA) and the 'known-groups' method. Internal reliability was assessed by Kuder-Richarson Formula 20 and Cronbach's alpha coefficient and external reliability by interclass correlation coefficient among participants who completed the instrument at baseline and two weeks later (n = 28).ResultsFace and content validity resulted in the removal of 61 items from the initial 151 items. Psychometric testing was applied to the refined 90-item questionnaire administered to participating dietitians, resulting in the final 46-item questionnaire. Six factors were extracted by PCA with varimax rotation explaining 59.2% of the total variance. Partial confirmatory factor analysis showed an acceptable model fit (χ2/df = 2.11, CFI = 0.97, TLI = 0.96, RMSEA = 0.08, SRMR = 0.05). Significant differences were found in sum scores among dietitians with different levels of IBS experience. Internal reliability was >0.7 for each factor. External reliability was >0.6 for each factor and >0.7 for overall items of each domain.ConclusionA validated questionnaire to use in practice and research to assess knowledge, attitudes and practices in the dietary management of IBS has been developed.

Dataset Information

Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals.

Publications

Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals.

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