title: 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.
authors: Department of Chemical Engineering, Indian Institute of Technology Delhi, Hauz Khas, New Delhi, India.
authors: Anurag S
authors: AS
authors: Rathore
authors: Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria.|Department of Industrial Engineering, Universidad Nacional de Colombia, Bogotá, Colombia.
authors: Oscar Fabián
authors: OF
authors: Garcia-Aponte
authors: Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria.
authors: Aydin
authors: A
authors: Golabgir
authors: Department of Pharmacy, Universidad Nacional de Colombia, Bogotá, Colombia.
authors: Bibiana Margarita
authors: BM
authors: Vallejo-Diaz
authors: Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria. christoph.herwig@tuwien.ac.at.|CD Laboratory on Mechanistic and Physiological Methods for Improved Bioprocesses, Vienna University of Technology, Vienna, Austria. christoph.herwig@tuwien.ac.at.
authors: Christoph
authors: 0000-0003-2314-1458
authors: C
authors: Herwig
mesh_terms: D001688:Biological Products / Q000737:chemistry*; D001702:Biopharmaceutics / Q000379:methods; D015195:Drug Design; D004345:Drug Industry / Q000379:methods; D006801:Humans; D058436:Knowledge Management; D011786:Quality Control
chemical_list: D001688:Biological Products
keywords: knowledge indicators; knowledge management; ontologies; process modeling; quality by design