Advances in Technology and Process Development for Industrial-Scale Monoclonal Antibody Purification

Process Scale Purification of Antibodies

Volumn , Issue , 2008, Pages 203-221

  Fontes, Nuno ^a   van Reis, Robert ^a  

^a GENENTECH INC   (United States)

Author keywords

Advances in technology and process development; Affinity purification platform; Two step nonaffinity approaches in mAb purification

Indexed keywords

EID: 84890642098     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470444894.ch10     Document Type: Chapter

References (34)

1. Harinarayan. C.. Mueller. J.. Ljunglöf. A.. Fahrner. R.. van Reis. R. ( 2002 ).Development of novel ion exchange process conditions in antibody purification . Presentationat Antibody Production and Downstream Processing, IBC conference, San Diego, CA, November 18, 2002.
2. Harinarayan. C.. Mueller. J.. Ljunglöf. A.. Fahrner. R.. van Alstine. J.. Van Reis. R. ( 2006 ). An exclusion mechanism in ion exchange chromatography . Biotechnology and Bioengineering 95. 775-787.
3. Kaczmarskil. K.. Bellot. J.C. ( 2003 ). Effect of particle - size distribution and particle porosity changes on mass - transfer kinetics . Acta Chromatographica 13. 22-37.
4. Piatkowski. W.. Gritti. F.. Kaczmarski K.. Guiochon. G. ( 2003 ). Infl uence of the particle porosity on chromatographic band profiles . Journal of Chromatography A 989. 207-219.
5. Wesselingh. J.A.. Bosma. J.C. ( 2001 ). Protein ion - exchange adsorption kinetics . American Institute of Chemical Engineers Journal 47. 1571-1580.
6. Shukla. A.A.. Hubbard. B.. Tressel. T.. Guhanb. S.. Low. D. ( 2007 ). Downstream processing of monoclonal antibodies - Application of platform approaches . Journal of Chromatography B 848. 28-39.
7. Kern. G. ( 2007 ) Increasing downstream processing capacity: New technologies for purification and contaminant removal . Millipore, Bioproduction 2007, Berlin, Germany, 2007.
8. Hahn. R.. Schlegel. R.. Jungbauer. A. ( 2003 ). Comparison of Protein A affinity sorbents . Journal of Chromatography 790. 35-51.
9. Swinnen. K.. Krul. A.. Van Goidsenhoven. I.. Van Tichelt. N.. Roosen. A.. Van Houdt. K. ( 2007 ). Performance comparison of Protein A affinity resins for the purification of monoclonal antibodies . Journal of Chromatography B 848. 97-107.
10. Follman. D.K.. Fahrner. R.L. ( 2004 ). Factorial screening of antibody purification processes using three chromatography steps without protein A . Journal of Chromatography A 1024. 70-85.
11. Low. D.. O ' Leary. R.. Pujar. N.S. ( 2007 ). Future of antibody purification . Journal of Chromatography B 848. 48-63.
12. Fahrner. R.. Follman, D.. Lebreton, B.. van Reis. R. ( 2008). Non- affinity purification of proteins. US Patent #7323553.
13. Mehta. A.. Tse. M.. Fogle. J.. Len. A.. Shrestha. R.. Fontes. N.. Lebreton. B.. Wolk, B.. van Reis. R. ( 2008 ). Purifying therapeutic monoclonal antibodies . Chemical Engineering Progress, SBE Supplement: Bioprocessing 104 (5). S14-20.
14. Stone. M.C.. Carta. G. ( 2007 ). Protein adsorption and transport in agarose and dextran - grafted agarose media for ion exchange chromatography . Journal of Chromatography A 1146. 202-215.
15. Susanto. A.. Wekenborga. K.. Hubbuchb. J.. Schmidt - Trauba. H. ( 2006 ). Developing a chromatographic column model for bovine serum albumin on strong anion -exchanger Source30Q using data from confocal laser scanning microscopy . Journal of Chromatography A 1137. 63-75.
16. Chang. C.. Lenhoff. A.M. ( 1998 ). Comparison of protein adsorption isotherms and uptake rates in preparative cation - exchnange materials . Journal of Chromatography A 87. 281-293.
17. Dziennik. S.R.. Belcher. E .B.. Barker. G.A.. D eBergalis. M .J.. Fernandez. S.E.. Lenhoff. A.M. ( 2003 ). Nondiffusive mechanisms enhance protein uptake rates in ion exchange particles . Proceedings of the National Academy of Sciences of the United States of America 100. 420-425.
18. Dziennik. S .R.. Belcher. E .B.. Barker. G.A.. Lenhoff A.M. ( 2005 ) Effects of ionic strength on lysozyme uptake rates in cation exchangers. I: Uptake in SP Sepharose FF . Biotechnology and Bioengineering 91. 139-153.
19. Langford. J .F. Jr. ., Xua. X.. Yao. Y .. Maloney. S .F.. Lenhoff. A.M. ( 2007 ). C hromatography of proteins on charge - variant ion exchangers and implications for optimizing protein uptake rates . Journal of Chromatography A 1163. 190-202.
20. Yuan. Y.. Oberholzer. M.R.. Lenhoff. A.M. ( 2000 ). Size does matter: Electrostatically determined surface coverage trends in protein and colloid adsorption . Colloids and Surfaces A: Physicochemical and Engineering Aspects 165. 125-141.
21. Fontes. N.. Sutherland. J.. Banerjee. D.. Malmquist. G.. Van Reis. R. ( 2008 ). Unpublished manuscript.
22. Van Reis. R. ( 2006 ). Charge exclusion phenomena in separation media. http:// membership.acs.org/b/biochem/content/Best_of_BIOT/Recovery0605/v2/biotsym. html (BIOT Web symposia).
23. Van Reis. R. ( 1993 ). Tangential fl ow filtration process and apparatus.US Patent #5256294.
24. Van Reis. R.. Gadam. S.. Frautschy. L.N.. Orlando. S.. Goodrich. E.M.. Saksena. S.. Kuriyel. R.. Simpson. C.. Pearl. S.. Zydney. A.L. ( 1997 ). High performance tangential fl ow filtration . Biotechnology and Bioengineering 56. 71-82.
25. Zydney. A.. van Reis. R. ( 2001 ). High performance tangential fl ow filtration . In Wang. W.K. (ed.) Membrane Separations in Biotechnology. Marcel Dekker. New York, NY. pp. 277-298.
26. Van Reis. R.. Zydney. A. ( 2007 ). Bioprocess membrane technology . J ournal of Membrane Science 297. 16-50.
27. Van Reis. R.. Brake. J.M.. Charkoudian. J.. Burns. D.B.. Zydney. A.L. ( 1999 ). High performance tangential fl ow filtration using charged membranes . Journal of Membrane Science 159. 133-142.
28. Ebersold. M.F.. Zydney. A.L. ( 2004 ). Separation of protein charge variants by ultrafiltration . Biotechnology Progress 20. 543-549.
29. Lebreton. B.. Brown. A.. van Reis. R. ( 2008 ). Application of high performance tangential fl ow filtration (HPTFF) to the purification of a human pharmaceutical antibody fragment expressed in Escherichia coli. Biotechnology and Bioengineering 100 (5). 964-974.
30. Van Reis. R. ( 1996 ). Tangential fl ow filtration process and apparatus. US Patent #5490937.
31. Van Reis. R. ( 2000 ). Tangential fl ow filtration process and apparatus. US Patent #6054051.
32. Van Reis. R.. Saksena. S. ( 1997 ). Optimization diagram for membrane separations . Journal of Membrane Science 129. 19-29.
33. Fontes. N.. Molek. J.. Len. A.. Steen. J.. Xenopoulos, A.. Charkoudian. J.. van Reis. R. ( 2007 ). HPTFF for industrial - scale non - affinity mAb purification . Presentation at the North American Membrane Society Meeting, Orlando, FA, 2007.
34. Arunakumari. A.. Wang. J.. Ferreira. G. ( 2007 ). Alternatives to Protein A: Improved downstream process design for human monoclonal antibody production . BioPharm International 20. 15-19