Monitoring Mammalian Cell Cultivations for Monoclonal Antibody Production Using Near-Infrared Spectroscopy
- João G. HenriquesAffiliated with4TUNE Engineering Ltd – Atrium SaldanhaHOVIONE, Sete Casas
- , Stefan BuziolAffiliated withRoche Diagnostics GmbH – Pharmaceutical Biotech Production and Development
- , Elena StockerAffiliated withRoche Diagnostics GmbH – Pharmaceutical Biotech Production and Development
- , Arthur VoogdAffiliated withYokogawa Europe BVLaboSer BV
- , José C. MenezesAffiliated withIBB-Institute for Biotechnology and Bioengineering, IST-Technical University of Lisbon Email author
Near-infrared (NIR) spectroscopy as a process monitoring and process supervision technique is reviewed in the context of biomanufacturing.
An industrial pilot-plant mammalian cell cultivation process has been chosen to illustrate the use of on-line in-situ NIR monitoring by means of an immersion transflectance NIR probe.
NIR calibration development must be performed carefully and should incorporate a number of steps to obtain a properly validated model which exhibits long-term robustness and is independent of process scale. A description of such good modelling practises is given. In general, NIR can be as accurate as the reference methods employed and at least as precise provided that sufficient spectral selectivity and sensitivity exists.
NIR can also be used as a direct technique for very fast process monitoring and process supervision, thus enabling one to follow the trajectory of a process. This alternative to the indirect use of NIR through laborious calibration development with direct reference methods has been little explored. Since NIR is sensitive to both chemical and physical properties, the analysis of whole samples enables relevant process information to be captured and thus generates better process state estimates than by simply looking at defined process parameters one at a time.
KeywordsProcess Analytical Technology Biomanufacturing Process Spectro scopy NIR mammalian cells cultivation
- Monitoring Mammalian Cell Cultivations for Monoclonal Antibody Production Using Near-Infrared Spectroscopy
- Book Title
- Optical Sensor Systems in Biotechnology
- pp 29-72
- Print ISBN
- Online ISBN
- Series Title
- Advances in Biochemical Engineering / Biotechnology
- Series Volume
- Series ISSN
- Springer Berlin Heidelberg
- Copyright Holder
- Springer-Verlag Berlin Heidelberg
- Additional Links
- Process Analytical Technology
- Spectro scopy
- mammalian cells cultivation
- Industry Sectors
- eBook Packages
- Govind Rao (ID1)
- Editor Affiliations
- ID1. Dept. Chemical & Biochemical, University of Maryland, Baltimore County
- Author Affiliations
- 1. 4TUNE Engineering Ltd – Atrium Saldanha, PC Duque Saldanha 1–10G, 1050–094, Lisbon, Portugal
- 2. HOVIONE, Sete Casas, 2674–506, Lisbon, Portugal
- 3. Roche Diagnostics GmbH – Pharmaceutical Biotech Production and Development, Nonnenwald 2, Penzberg, 82377, Germany
- 4. Yokogawa Europe BV, Databankweg 20, 3821, AL, Amersfoort, The Netherlands
- 5. LaboSer BV, Beukelsdijk 65, 3021, AD, Rotterdam, The Netherlands
- 6. IBB-Institute for Biotechnology and Bioengineering, IST-Technical University of Lisbon, Av. Rovisco Pais, 1049–001, Lisbon, Portugal
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