Chemometrics and in-line near infrared spectroscopic monitoring of a biopharmaceutical Chinese hamster ovary cell culture: Prediction of multiple cultivation variables

Talanta

Volumn 111, Issue , 2013, Pages 28-38

  Clavaud, Matthieu ^a   Roggo, Yves ^a   Von Daeniken, Ralph ^a   Liebler, André ^a   Schwabe, Jan Oliver ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Bioprocess monitoring; Cell culture; Chemometrics; Chinese hamster ovary; Near infrared spectroscopy; Process analytical technology

Indexed keywords

BIOREACTORS; CELL CULTURE; CELLS; CONTROL CHARTS; DATA HANDLING; FLOWCHARTING; INFRARED DEVICES; LEAST SQUARES APPROXIMATIONS; MAMMALS; MONOCLONAL ANTIBODIES; MULTIVARIANT ANALYSIS; NEAR INFRARED SPECTROSCOPY; PRINCIPAL COMPONENT ANALYSIS; REGRESSION ANALYSIS; SPECTROMETERS; SPECTRUM ANALYSIS;

BIOPROCESS MONITORING; CHEMOMETRICS; CHINESE HAMSTER OVARY; CHINESE HAMSTER OVARY CELLS; FOURIER TRANSFORM NEAR INFRARED; MULTIVARIATE DATA ANALYSIS; PARTIAL LEAST SQUARES REGRESSION; PROCESS ANALYTICAL TECHNOLOGY;

BATCH CELL CULTURE;

EID: 84876268622     PISSN: 00399140     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.talanta.2013.03.044     Document Type: Article

References (20)

1. FDA, Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Available from: 〈http://www.fda.gov/downloads/Drugs/./Guidances/ ucm070305.pdf,2004âŒ. (accessed 29.10.12).
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use. ICH Harmonised Tripartite Guideline Pharmaceutical Development Q8(R2). Available from: 〈http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/ Guidelines/Quality/Q8-R1/Step4/Q8-R2-Guideline.pdf,August2009âŒ. (accessed 14.03.13).
3. Y. Roggo, P. Chalus, L. Maurer, C. Lema-Martinez, A. Edmond, and N. Jent J. Pharm. Biomed. Anal. 44 2007 683 700
4. H. Mark, and J. Workman Jr. Statistics in Spectroscopy 2nd Edition 2003 Elsevier Amsterdam
5. H. Martens, and T. Naes J. Chemometrics 4 1992 217 225
6. C. Hakemeyer, U. Strauss, S. Werz, G.E. Joseb, F. Folque, and J.C. Menezes Talanta 90 2012 12 21
7. T. Strother Spectrosc. Europe 23 2011 18 21
8. C. Card, B. Hunsaker, T. Smith, and J. Hirsch BioProcess Int. 6 2008 58 67
9. P. Roychoudhury, R. O'Kennedy, B. McNeil, and L.M. Harvey Anal. Chim. Acta 590 2007 110 117
10. S.A. Arnold, J. Crowley, N. Woods, L.M. Harvey, and B. McNeil Biotechnol. Bioeng. 84 2009 13 19
11. S. Harthun, K. Matischak, and P. Friedl Biotechnol. Tech. 12 1998 393 398
12. J. Hirsch, Thermo Fisher Scientific Madison, WI, USA, 2008.
13. Note for guidance on the Use of NIR spectroscopy by Pharmaceutical industry and the data requirements for new submissions and variations. EMEA/CVMP/961/01. Available from: 〈http://www.emea.europa.eu/ docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003331.pdf, 2003âŒ. (accessed 14.03.13).
14. A. Candolfi, R. De Maesschalck, D.L. Massart, P.A. Hailey, and A.C.E. Harrington J. Pharm. Biomed. Anal. 19 1999 923 935
15. A. Rinnan, F.V.D. Berg, and S. Balling Engelsen TrAC Trends Anal Chem 28 2009 1201 1222
16. T. Rajalahti, and O.M. Kvalheim Int. J. Pharm. 417 2011 280 290
17. M. Yoshikatsu, I. Toshiaki, K. Hiroyuki, and S. Shin-Ichi J. Chemometrics 4 1990 97 100
18. P.C. Williams, and D.C. Sobering A.M.C. Davies, P.C. Williams, How do we do it: a Brief Summary of the Methods we use in Developing Near Infrared Calibrations - Near Infrared Spectroscopy: The Future Waves 1996 NIR Publications Chichester pp. 185-188
19. T. Fearn NIR News 13 2002 12 14
20. R.J. Barnes, M.S. Dhanoa, and S.J. Lister Appl. Spectrosc. 43 1989 772 777