Design of Experiments; Quality by Design; Design Space; Critical process parameters; Critical quality attributes
Abstract :
[en] The optimization of pharmaceutical bioprocesses suffers from several challenges like complexity, upscaling costs, regulatory approval, leading to the risk of delivering substandard drugs to patients. Bioprocess is very complex and requires the evaluation of multiple components that need to be monitored and controlled in order to attain the desired state when the process ends. Statistical design of experiments (DoE) is a powerful tool for optimizing bioprocesses because it plays a critical role in the quality by design strategy as it is useful in exploring the experimental domain and providing statistics of interest that enable scientists to understand the impact of critical process parameters on the critical quality attributes. This review summarizes selected publications in which DoE methodology was used to optimize bioprocess. The main objective of the critical review was to clearly demonstrate potential benefits of using the DoE and design space methodologies in bioprocess optimization.
Research center :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Kasemiire, Alice ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Avohou, Tonakpon Hermane ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
De Bleye, Charlotte ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Sacre, Pierre-Yves ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Dumont, Elodie
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Design of experiments and design space approaches in the pharmaceutical bioprocess optimization
Publication date :
11 June 2021
Journal title :
European Journal of Pharmaceutics and Biopharmaceutics
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