Validation of the cell culture monitoring using a Raman spectroscopy calibration model developed with artificially mixed samples and investigation of model learning methods using initial batch data

Author:

Hara RisaORCID,Kobayashi Wataru,Yamanaka Hiroaki,Murayama KodaiORCID,Shimoda Soichiro,Ozaki YukihiroORCID

Publisher

Springer Science and Business Media LLC

Subject

Biochemistry,Analytical Chemistry

Reference33 articles.

1. Mali AS, Jagtap M, Karekar P, Maruška A. A brief review on process analytical technology (PAT). Int J Curr Pharm Res. 2016;8:10–5.

2. Simon LL, Pataki H, Marosi G, Meemken F, Hungerbühler K, Baiker A, et al. Assessment of recent process analytical technology (PAT) trends: a multiauthor review. Org Process Res Dev. 2015;19:3–62.

3. Bakeev KA. Process analytical technology: spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries. Chichester: Wiley; 2010.

4. US Food and Drug Administration (FDA). Guidance for industry: PAT: a framework for innovative pharmaceutical development, manufacturing, and quality assurance. Rockville, Maryland: Center for Veterinary Medicine, Office of Regulatory Affairs, Center for Drug Evaluation and Research. 2004. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance. Accessed 25 Aug 2023.

5. Sommeregger W, Sissolak B, Kandra K, von Stosch M, Mayer M, Striedner G. Quality by control: towards model predictive control of mammalian cell culture bioprocesses. Biotechnol J. 2017;12:1600546.

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