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:

SUBMITTER: Rathore AS 

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

REPOSITORIES: biostudies-literature