Application of In Situ Near Infra-Red Spectroscopy for Monitoring Biopharmaceuticals Production by Cell Cultures



The complexity of biopharmaceutical products implies that their approval is based on a specific process. Any further change, especially in the process, requires drug validation in terms of clinical effects and biosecurity. Because changes in the processes may be unavoidable, quality assurance by inspection at the end of the process (Quality by Testing-QbT) tends to be replaced by a new quality perspective called Quality by design (QbD) which builds drug Critical Quality Attributes (CQA) controlling key Critical Process Parameters (CPP) in real-time. Consequently, the objective of this work has been to develop new methodological and experimental applications, based on in situ NIR spectroscopy, for real-time monitoring of biopharmaceutical-producing cell cultures.
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