title: Knowledge management in the QbD paradigm: manufacturing of biotech therapeutics.
abstract: 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.
authors.affiliation: Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria; Christian Doppler Laboratory for Mechanistic and Physiological Methods for Improved Bioprocesses, Vienna University of Technology, Vienna, Austria.
authors.forename: Christoph
authors.initials: C
authors.lastname: Herwig
authors.affiliation: Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria; Department of Industrial Engineering, National University of Colombia, Bogotá, Colombia.
authors.forename: Oscar F
authors.initials: OF
authors.lastname: Garcia-Aponte
authors.affiliation: Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria.
authors.forename: Aydin
authors.initials: A
authors.lastname: Golabgir
authors.affiliation: Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi, India. Electronic address: asrathore@biotechcmz.com.
authors.forename: Anurag S
authors.initials: AS
authors.lastname: Rathore
mesh_terms: D001709:Biotechnology; D058436:Knowledge Management; D012308:Risk Management; D013678:Technology, Pharmaceutical
keywords: bioprocessing; knowledge management; quality by design