Near-infrared and two-dimensional fluorescence spectroscopy monitoring of monoclonal antibody fermentation media quality: Aged media decreases cell growth

Biotechnology Journal

Volumn 8, Issue 7, 2013, Pages 835-846

  Hakemeyer, Christian ^a   Strauss, Ulrike ^a   Werz, Silke ^a   Folque, Francisca ^b   Menezes, Jose C ^c  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

^b Technology Services and Products   (Portugal)

^c INSTITUTO SUPERIOR TÉCNICO   (Portugal)

Author keywords

2D fluorescence spectroscopy; Aging effects; Media components; Monoclonal antibody cultivation; Near infrared spectroscopy

Indexed keywords

2D-FLUORESCENCE SPECTROSCOPY; AGING EFFECTS; CHINESE HAMSTER OVARY CELLS; COMPOSITIONAL CHANGES; MEDIA COMPONENTS; MONOCLONAL ANTIBODIES (MABS); MONOCLONAL ANTIBODY CULTIVATIONS; SPECTROSCOPIC METHOD;

CELL CULTURE; CELL GROWTH; GROWTH KINETICS; MONOCLONAL ANTIBODIES; SPECTROSCOPIC ANALYSIS; TWO DIMENSIONAL;

FLUORESCENCE SPECTROSCOPY;

MONOCLONAL ANTIBODY;

ANIMAL CELL; ARTICLE; CELL CULTURE; CELL GROWTH; COMPARATIVE STUDY; CONTROLLED STUDY; CULTURE MEDIUM; FEMALE; FERMENTATION; FLUORESCENCE SPECTROSCOPY; FREEZE DRYING; FREEZING; HEAT TREATMENT; MONITORING; NEAR INFRARED SPECTROSCOPY; NONHUMAN; OXIDATION; POWDER; PRIORITY JOURNAL; PROTEIN DEGRADATION; QUALITY CONTROL; STORAGE; TIME; TWO DIMENSIONAL FLUORESCENCE SPECTROSCOPY;

2D-FLUORESCENCE SPECTROSCOPY; AGING EFFECTS; MEDIA COMPONENTS; MONOCLONAL ANTIBODY CULTIVATION; NEAR-INFRARED SPECTROSCOPY;

ANIMALS; ANTIBODIES, MONOCLONAL; CELL CULTURE TECHNIQUES; CHO CELLS; CRICETINAE; CRICETULUS; CULTURE MEDIA; FERMENTATION; PRINCIPAL COMPONENT ANALYSIS; SPECTROMETRY, FLUORESCENCE; SPECTROSCOPY, NEAR-INFRARED; TIME FACTORS;

CRICETULUS GRISEUS;

EID: 84879768106     PISSN: 18606768     EISSN: 18607314     Source Type: Journal    
DOI: 10.1002/biot.201200355     Document Type: Article

References (27)

1. Gnoth, S., Jenzsch, M., Simutis, R., Lubbert, A., Process analytical technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control. J. Biotech. 2007, 132, 180-186.
2. Lanan, M., QbD for raw materials, in: Rathore, A.S., Mhatre, R. (Eds.), Quality by Design for Biopharmaceuticals: Principles and Case Studies. Wiley Interscience Hoboken N.J. 2009, pp.193-210.
3. Luo, Y., Chen, G., Combined approach of NMR and chemeometrics for screening peptones used in the cell culture medium for the production of recombinant therapeutic proteins. Biotechnol. Bioeng. 2007, 97, 1654-1659.
4. Rodionova, O. Y., Sokovikov, Y. V., Pomerantsev, A. L., Quality control of packed raw materials in pharmaceutical industry. Anal. Chim. Acta 2009, 642, 222-227.
5. Henriques, J. G., Buziol, S., Stocker, E., Voogd, A. et al., Monitoring mammalian cell cultivations for monoclonal antibody production using near-infrared spectroscopy. Adv. Biochem. Engin./ Biotechnol. 2010, 116, 73-97.
6. Vaidyanathan, S., Arnold, S. A., Matheson, L., Mohan, P. et al., Assessment of near-infrared spectral information for rapid monitoring of bioprocess quality. Biotechnol. Bioeng. 2001, 74, 376-388.
7. Lee, H. W., Christie, A., Liu, J. J., Yoon, S., Estimation or raw material performance in mammalian cell culture using near infrared spectra combined with chemometrics approaches. Biotechnol. Prog. 2012, 28, 824-832.
8. Lee, H. W., Christie, A., Liu, J. J., Yoon, S., Data fusion-based assessment or raw materials in mammalian cell culture. Biotechnol. Bioeng. 2012, 109, 2819-2828.
9. Kornmann, H., Rhiel, M., Cannizzaro, C., Marison, I. et al., Methodology for real-time, multianalyte monitoring of fermentations using an in-situ mid-infrared sensor. Biotechnol. Bioeng. 2003, 82, 702-709.
10. Roychoudhury, P., Harvey, L. M., McNeil, B., The potential of mid infrared spectroscopy (MIRS) for real time bioprocess monitoring. Anal. Chim. Acta 2006, 571, 159-166.
11. Cannizzaro, C., Rhiel, M., Marison, I., von Stockar, U., On-line monitoring of Phaffia rhodozyma fed-batch process with in-situ dispersive Raman spectroscopy. Biotechnol. Bioeng. 2003, 83, 668-680.
12. Lee, H. L. T., Bocazzi, P., Gorret, N., Ram, J. R. et al., In situ bioprocess monitoring of Escherichia coli bioreactions using Raman spectroscopy. Vib. Spectrosc. 2004, 35, 131-137.
13. Li, B., Ryan, P. W., Ray, B. H., Leister, K. J. et al., Rapid characterisation and quality control of complex cell culture media solutions using Raman spectroscopy and chemometrics. Biotech. Bioeng. 2010, 107, 290-301.
14. Jose, G. E., Folque, F., Menezes, J. C., Werz, S. et al., Predicting mAb product yields from cultivation media components, using near-infrared and 2D-fluorescence spectroscopies. Biotechnol. Prog. 2011, 27, 1339-1346.
15. Ryan, P. W., Boyan, L., Shanahan, M., Leister, K.J. et al., Prediction of cell culture media performance using fluorescence spectroscopy. Anal. Chem. 2010, 82, 1311-1317.
16. Näs, T., Isaksson, T., Fearn, T., Davies, T. (Ed.), A user friendly guide to multivariate calibration and classification, NIR Publications, 2002.
17. Miller, C. E., Chemometrics in Process Analytical Chemistry, in: Bakeev, K. A. (Ed.), Process Analytical Technology - Spectroscopic Tools and Implementation. Strategies for the Chemical and Pharmaceutical Industries. Blackwell Publishing Oxford 2005, pp. 353-438.
18. Norgaard, L., Saudland, A., Wagner, J., Nielsen, J. P. et al., Interval partial least-squares regression (iPLS): A comparative chemometric study with an example from near-infrared spectroscopy. Appl. Spectros. 2000, 54, 413-419.
19. Bahram, M., Bro, R., Stedmon, C., Afkhami, A., Handling of Rayleigh and Raman scatter for PARAFAC modeling of fluorescence data using interpolation. J. Chemometr. 2006, 20, 99-105.
20. Becker, E.M., Christensen, J., Frederiksen, C. S., Haugaard, V. K., Front-face spectroscopy and chemometrics in analysis of yogurt: Rapid analysis of riboflavin. J. Dairy Sci. 2003, 86, 2508-2515.
21. Galvão, R., Araújo, M., Jose, G.E. et al., Pontes, A method for calibration and validation subset partitioning. Talanta 2005, 67, 736-740.
22. Molony, M., Undey, C., PAT Tools for Biologics: Considerations and challenges, in: Rathore A.S., Mhatre, R. (Eds.), Quality by Design for Biopharmaceuticals: Principles and Case Studies. Wiley Interscience Hoboken N.J. 2009, pp. 211-254.
23. Halliwell, B., Oxidative stress in cell culture: An under-appreciated problem? FEBS Letters 2003, 540, 3-6.
24. Schacter E. Quantification and significance of protein oxidation in biological samples. ISSX 2000, 32, 307-326.
25. rd World Meeting APV/APGI, Berlin, 2000, pp. 335-336.
26. Reich, G., Near infrared spectroscopy and imaging: Basic principles and pharmaceutical applications. Adv. Drug Deliv. 2005, 57, 1109-1143.
27. Skibsted, E., PAT Applied to Pharmaceutical Raw Materials, in: Undey, C., Low, D., Menezes, J. C., Koch, M. (Eds.), Process Analytical Technology Applied in Biopharmaceutical Process Development and Manufacturing: Enabling Tool for Quality-by-Design, Taylor & Francis, Boca Raton F.L. 2011, pp. 127-141.