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.
Research Area Biochemical Engineering, Institute of Chemical Engineering, Vienna University of Technology, Vienna, Austria; Department of Industrial Engineering, National University of Colombia, Bogotá, Colombia.
Trends Biotechnol. 2015 Jul;33(7):381-7. doi: 10.1016/j.tibtech.2015.04.004. Epub 2015 May 13.
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.
在质量源于设计（QbD）范式中，全球监管机构引入了质量风险管理和知识管理（KM）的概念，将其作为增强药物质量体系的手段。尽管质量风险管理的概念在文献中已有很好的阐述，但 KM 这一主题相对较少受到关注。在本文中，我们就 QbD 范式中的 KM 提出了一些观点，这些观点与生物技术治疗产品的制造有关。我们考虑了学术和工业的观点，并阐明了关键的差距。作者得出的结论是，如果生物技术行业希望在 QbD 实施中取得成功，就迫切需要创建有效的 KM 方法。
