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Knowledge management in the QbD paradigm: manufacturing of biotech therapeutics

Paper ID Volume ID Publish Year Pages File Format Full-Text
36959 45291 2015 7 PDF Available
Title
Knowledge management in the QbD paradigm: manufacturing of biotech therapeutics
Abstract

•We present a classification of knowledge management tools based on ICH Q guidelines.•Integrative and lifecycle knowledge management tools are discussed.•A special effort is needed for effective knowledge management in technology transfer.

In the quality by design (QbD) paradigm, global regulatory agencies have introduced the concepts of quality risk management and knowledge management (KM) as enablers for an enhanced pharmaceutical quality system. Although the concept of quality risk management has been well elucidated in the literature, the topic of KM has received relatively scant attention. In this paper we present an opinion on KM in the QbD paradigm as it relates to the manufacturing of biotech therapeutic products. Both academic and industrial viewpoints have been considered and key gaps have been elucidated. The authors conclude that there is an urgent need for the biotech industry to create efficient KM approaches if they wish to be successful in QbD implementation.

Keywords
knowledge management; quality by design; bioprocessing
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Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 33, Issue 7, July 2015, Pages 381–387
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
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Full-text PDF Download
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