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• W2972202286 abstract "Quality by design (QbD) approach and associated ICH Q8, Q9, and Q10 recommendations are increasingly being adopted by the biopharmaceutical industry. Quality must be built in and not only ensured by controls and inspection. Indeed, a robust process design together with process understanding and sound quality system with appropriate quality control assures quality throughout the product life cycle. This chapter describes how to design and qualify a film following QbD principles from the early stage of material and suppliers selection up to control and change management. Materials science and engineering competences coupled to cell culture knowledge, partnership with relevant suppliers, and robust supply chain guaranteed first that the film met application requirements for cell growth and mechanical robustness and second, that bag qualification will stay valid during the single-use bag life cycle in applications. A control strategy based on raw material and process control with multivariate data analysis contributes to limiting variability and batch-to-batch variations." @default.
• W2972202286 created "2019-09-12" @default.
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• W2972202286 date "2019-07-26" @default.
• W2972202286 modified "2023-09-23" @default.
• W2972202286 title "How to Design and Qualify an Improved Film for Storage and Bioreactor Bags" @default.
• W2972202286 cites W2013004443 @default.
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• W2972202286 doi "https://doi.org/10.1002/9781119477891.ch19" @default.
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