Risk assessment and integrated process modeling–an improved QbD approach for the development of the bioprocess control strategy

Risk assessment and integrated process modeling–an improved QbD approach for the development of the bioprocess control strategy

A Process characterization is a regulatory imperative for process validation within the biopharmaceutical industry. Several individual steps must be conducted to achieve the final control strategy. For that purpose, tools from the Quality by Design (QbD) toolbox are often considered. These tools req...

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Bibliographic Details
Main Authors: Daniel Borchert, Diego A. Suarez-Zuluaga, Yvonne E. Thomassen, Christoph Herwig
Format: Article
Language:English
Published: AIMS Press 2020-11-01
Series:AIMS Bioengineering
Subjects:
quality by design
improved qbd
cause and effect analysis
quantitative risk assessment
design space
integrated process model
control strategy
Online Access:http://www.aimspress.com/article/10.3934/bioeng.2020022/fulltext.html

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