Integration of scale-down experimentation and general rate modelling to predict manufacturing scale chromatographic separations

Journal of Chromatography A

Volumn 1217, Issue 44, 2010, Pages 6917-6926

  Gerontas, Spyridon ^a   Asplund, Magnus ^b   Hjorth, Rolf ^b   Bracewell, Daniel G ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b BIACORE AB   (Sweden)

Author keywords

General rate model; Inverse method; Ion exchange; Manufacturing scale; Scale down

Indexed keywords

BIOPHARMACEUTICALS; CHROMATOGRAPHIC SEPARATIONS; DEVELOPMENT TIME; DOWNSTREAM-PROCESSING; GENERAL RATE MODEL; INVERSE METHOD; MANUFACTURING SCALE; MASS-TRANSFER KINETICS; PROCESS UNDERSTANDING; SCALE-DOWN; SCALE-UP;

CHROMATOGRAPHIC ANALYSIS; EXPERIMENTS; INVERSE PROBLEMS; ION EXCHANGERS; LIQUID CHROMATOGRAPHY; MANUFACTURE;

ION EXCHANGE;

BOVINE SERUM ALBUMIN; LACTOFERRIN;

ADSORPTION KINETICS; ARTICLE; CALIBRATION; CHROMATOGRAPHY; CONTROLLED STUDY; DESORPTION; EXPERIMENTATION; MATHEMATICAL MODEL; PREDICTION; PRIORITY JOURNAL; PROCESS DESIGN; PROCESS DEVELOPMENT; SCALE DOWN; SCALE UP; SEPARATION TECHNIQUE; SIMULATION; VALIDATION STUDY;

ALGORITHMS; CHROMATOGRAPHY, ION EXCHANGE; COMPUTER SIMULATION; ION EXCHANGE RESINS; KINETICS; LACTOFERRIN; MODELS, THEORETICAL; REPRODUCIBILITY OF RESULTS; SERUM ALBUMIN, BOVINE;

EID: 77957675442     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2010.08.063     Document Type: Article

References (29)

1. International conference on harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use, ICH harmonized guideline Q8(R2): Pharmaceutical Development, Step 4, August 2009.
2. Rathore A.S., Winkle H. Nat. Biotechnol. 2009, 27:26.
3. Titchener-Hooker N.J., Dunnill P., Hoare M. Biotechnol. Bioeng. 2007, 100:473.
4. Hutchinson N., Chhatre S., Baldascini H., Davies J.L., Bracewell D.G., Hoare M. Biotechnol. Progr. 2009, 25:1103.
5. Melander W.R., El Rassi S., Horváth C. J. Chromatogr. 1989, 469.
6. Guiochon G., Felinger A., Shirazi D.G.G. Fundamentals of Preparative and Nonlinear Chromatography 2006, Academic Press. second ed.
7. Natarajan V., Bequette W., Cramer S.M. J. Chromatogr. A 2000, 876:51.
8. Mollerup J.M., Hansen T.B., Kidal S., Staby A. J. Chromatogr. A 2008, 1177:200.
9. Jakobsson N., Karlsson D., Axelsson J.P., Zacchi G., Nilsson B. J. Chromatogr. A 2005, 1063:99.
10. Forrer N., Butté A., Morbidelli M. J. Chromatogr. A 2008, 1214:59.
11. Forssén P., Arnell R., Fornstedt T. Compos. Chem. Eng. 2006, 883:1381.
12. Antos D., Piatkowski W., Kaczmarski K. J. Chromatogr. A 2000, 874:1.
13. Orellana C.A., Shene C., Asenjo J.A. Biotechnol. Bioeng. 2009, 104:572.
14. Jungbauer A., Kaltenbrunner O. Biotechnol. Bioeng. 1996, 52:223.
15. Suda E.J., Thomas K.E., Pabst T.M., Mensah P., Ramasubramanyan N., Gustafson M.E., Hunter A.K. J. Chromatogr. A 2009, 1216:5256.
16. De Philips P., Lenhoff A.M. J. Chromatogr. A 2000, 883:39.
17. Gu T. Mathematical modeling and scale-up of liquid chromatography 1995, Springer, Berlin.
18. Wilson E.J., Geankoplis C.J. Ind. Eng. Chem. Fundam. 1966, 5:9.
19. Polson A. J. Phys. Colloid Chem. 1950, 54:649.
20. Schwartz C.E., Smith J.M. Ind. Eng. Chem. 1953, 45:1209.
21. Bowes B.D., Koku H., Czymmek K.J., Lenhoff A.M. J. Chromatogr. A 2009, 1216:7774.
22. Vicente T., Mota J.P., Peixoto C., Alves P.M., Carrondo M.J. J. Chromatogr. A 2010, 1217:2032.
23. Chase H.A. J Chromatogr. 1984, 291:179.
24. Stone M.C., Tao Y., Carta G. J. Chromatogr. A 2009, 1216:4465.
25. To B.C., Lenhoff A.M. J. Chromatogr. A 2008, 1205:46.
26. Hubbuch J., Linden T., Knieps E., Ljunglöf A., Thömmes J., Kula M. J. Chromatogr. A 2003, 1021:93.
27. Wakabayashi H., Yamauchi K., Takase M. Int. Dairy J. 2006, 16:1241.
28. Boyer P.M., Hsu J.T. Am. Inst. Chem. Eng. J. 1992, 38:259.
29. Bowen W.R., Cao X.W., Williams P.M. Proc. R. Lond. Soc. Ser. A 1999, 455:2933.