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Generic R aman‐based calibration models enabling real‐time monitoring of cell culture bioreactors
Author(s) -
Mehdizadeh Hamidreza,
Lauri David,
Karry Krizia M.,
Moshgbar Mojgan,
ProcopioMelino Renee,
Drapeau Denis
Publication year - 2015
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.2079
Subject(s) - bioprocess , chinese hamster ovary cell , bioreactor , process analytical technology , calibration , critical quality attributes , computer science , scalability , quality by design , biochemical engineering , process (computing) , biological system , process engineering , cell culture , chemistry , downstream (manufacturing) , biology , engineering , mathematics , statistics , paleontology , operations management , organic chemistry , database , genetics , operating system
Raman‐based multivariate calibration models have been developed for real‐time in situ monitoring of multiple process parameters within cell culture bioreactors. Developed models are generic, in the sense that they are applicable to various products, media, and cell lines based on Chinese Hamster Ovarian (CHO) host cells, and are scalable to large pilot and manufacturing scales. Several batches using different CHO‐based cell lines and corresponding proprietary media and process conditions have been used to generate calibration datasets, and models have been validated using independent datasets from separate batch runs. All models have been validated to be generic and capable of predicting process parameters with acceptable accuracy. The developed models allow monitoring multiple key bioprocess metabolic variables, and hence can be utilized as an important enabling tool for Quality by Design approaches which are strongly supported by the U.S. Food and Drug Administration. © 2015 American Institute of Chemical Engineers Biotechnol. Prog ., 31:1004–1013, 2015