Towards model-based optimization for quality by design in biotherapeutics production

A Ehsani, CD Kappatou, A Mhamdi, A Mitsos… - Computer Aided …, 2019 - Elsevier
Abstract Quality by Design (QbD) is the concept of designing a process by gathered
knowledge to fulfill desired quality of the product. This requires monitoring and controlling
product quality throughout process development. In biotherapeutics production,
glycosylation is one of the major quality attributes. In general, the glycoform generated by
the cell glycosylation machinery is highly dependent on the cell performance and the
variations in its surrounding. Mathematical modelling of this machinery can facilitate process …
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