Anion exchange chromatography provides a robust, predictable process to ensure viral safety of biotechnology products

Biotechnology and Bioengineering

Volumn 102, Issue 1, 2009, Pages 168-175

  Strauss, Daniel M ^a   Gorrell, Jeffrey ^a   Plancarte, Magdalena ^a   Blank, Gregory S ^a   Chen, Qi ^a   Yang, Bin ^a  

^a GENENTECH INC   (United States)

Author keywords

Anion exchange chromatography; Conductivity; Monoclonal antibody purification; Process robustness; Salt composition; Viral clearance

Indexed keywords

ANION EXCHANGE CHROMATOGRAPHY; CONDUCTIVITY; MONOCLONAL ANTIBODY PURIFICATION; PROCESS ROBUSTNESS; SALT COMPOSITION; VIRAL CLEARANCE;

ANIMAL CELL CULTURE; CHEMICAL ANALYSIS; CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; FEEDSTOCKS; IMPURITIES; IONS; MAMMALS; MERGERS AND ACQUISITIONS; MICROORGANISMS; MONOCLONAL ANTIBODIES; NEGATIVE IONS; PURIFICATION; REGULATORY COMPLIANCE; SURFACE PLASMON RESONANCE; VIRUSES;

ANTIBODIES;

MONOCLONAL ANTIBODY; DRUG;

ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; BIOTECHNOLOGY; CONTROLLED STUDY; NONHUMAN; PROCESS DEVELOPMENT; SAFETY; VIRAL CONTAMINATION; DISINFECTION; DRUG TOXICITY; ION EXCHANGE CHROMATOGRAPHY; ISOLATION AND PURIFICATION; METHODOLOGY; VIRUS;

MAMMALIA;

ANTIBODIES, MONOCLONAL; BIOTECHNOLOGY; CHROMATOGRAPHY, ION EXCHANGE; DISINFECTION; DRUG TOXICITY; PHARMACEUTICAL PREPARATIONS; VIRUSES;

EID: 58149241256     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22051     Document Type: Article

References (38)

1. Adcock WL, MacGregor A, Davies JR, Hattarki M, Anderson DA, Goss NH. 1998. Chromatographic removal and heat inactivation of hepatitis A virus during manufacture of human albumin. Biotechnol Appl Bio- chem 28(Pt 1):85-94.
2. Anderson KP, Low MA, Lie YS, Keller GA, Dinowitz M. 1991. Endogenous origin of defective retroviruslike particles from a recombinant Chinese hamster ovary cell line. Virology 181(1):305-311.
3. Blanche F, Cameron B, Barbot A, Ferrero L, Guillemin T, Guyot S, Somarriba S, Bisch D. 2000. An improved anion- exchange HPLC method for the detection and purification of adenoviral particles. Gene Ther 7(12):1055-1062.
4. Brorson K. 2007. Advances in viral clearance. In: Shukla AA, Etzel MR, Gadam S, editors. Process scale bioseparations for the biopharmaceu- tical industry. Boca Raton: CRC Press. pp. 449-462.
5. Brorson K, De Wit C, Hamilton E, Mustafa M, Swann PG, Kiss R, Taticek R, Polastri G, Stein KE, Xu Y. 2002. Impact of cell culture process changes on endogenous retrovirus expression. Biotechnol Bioeng 80(3):257-267.
6. Burnouf T. 1995. Chromatography in plasma fractionation: Benefits and future trends. J Chromatogr B Biomed Appl 664(1):3-15.
7. Cameron R, Davies J, Adcock W, MacGregor A, Barford JP, Cossart Y, Harbour C. 1997. The removal of model viruses, poliovirus type 1 and canine parvovirus, during the purification of human albumin using ion-exchange chromatographic procedures. Biologicals 25(4):391-401.
8. Carlsson A, Kuznar J, Varga M, Everitt E. 1994. Purification of infectious pancreatic necrosis virus by anion exchange chromatography increases the specific infectivity. J Virol Methods 47(1-2):27-35.
9. CBER (Center for Biologics Evaluation and Research). 1997. Points to consider in the manufacture and testing of monoclonal antibody products for human use.
10. Curtis S, Lee K, Blank GS, Brorson K, Xu Y. 2003. Generic/matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mode. Biotechnol Bioeng 84(2):179-186.
11. EMEA (European Medicines Agency). 2006. Guideline on virus safety evaluation of biotechnological investigational medicinal products (draft).
12. Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerhelm D, Vanderlaan M, Blank GS. 2001. Industrial purification of pharmaceutical antibodies: Development, operation, and validation of chromatography processes. Biotechnol Genet Eng Rev 18:301-327.
13. Gagnon PS. 2007. Polishing methods for monoclonal IgG purification. In: Shukla AA, Etzel MR, Gadam S, editors. Process scale bioseparations for the biopharmaceutical industry. Boca Raton, FL: CRC Press. pp. 491-505.
14. Garnick RL. 1996. Experience with viral contamination in cell culture. Dev Biol Stand 88:49-56.
15. Huyghe BG, Liu X, Sutjipto S, Sugarman BJ, Horn MT, Shepard HM, Scandella CJ, Shabram P. 1995. Purification of a type 5 recombinant adenovirus encoding human p53 by column chromatography. Hum Gene Ther 6(11):1403-1416.
16. ICH (International Conference on Harmonization). 1999. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A.
17. ICH (International Conference on Harmonization). 2005. Pharmaceutical Development Q8.
18. Johnston A, Macgregor A, Borovec S, Hattarki M, Stuckly K, Anderson D, Goss NH, Oates A, Uren E. 2000. Inactivation and clearance of viruses during the manufacture of high purity factor IX. Biologicals 28(3):129-136.
19. Kalbfuss B, Wolff M, Morenweiser R, Reichl U. 2007. Purification of cell culture-derived human influenza A virus by size-exclusion and anion- exchange chromatography. Biotechnol Bioeng 96(5):932-944.
20. Konz JO, Livingood RC, Bett AJ, Goerke AR, Laska ME, Sagar SL. 2005. Serotype specificity of adenovirus purification using anion- exchange chromatography. Hum Gene Ther 16(11):1346-1353.
21. Kuiper M, Sanches RM, Walford JA, Slater NK. 2002. Purification of a functional gene therapy vector derived from Moloney murine leukaemia virus using membrane filtration and ceramic hydroxyapatite chromatography. Biotechnol Bioeng 80(4):445-453.
22. Kundu A, Reindel K. 2007. Evaluation of viral clearance in purification processes. In: Shukla AA, Etzel MR, Gadam S, editors. Process scale bioseparations for the biopharmaceutical industry. Boca Raton, FL: CRC Press. pp. 419-448.
23. Lieber MM, Benveniste RE, Livingston DM, Todaro GJ. 1973. Mammalian cells in culture frequently release type C viruses. Science 182(107):56-59.
24. Norling L, Lute S, Emery R, Khuu W, Voisard M, Xu Y, Chen Q, Blank G, Brorson K. 2005. Impact of multiple re-use of anion-exchange chro- matography media on virus removal. J Chromatogr A 1069(1):79-89.
25. O'Riordan CR, Lachapelle AL, Vincent KA, Wadsworth SC. 2000. Scaleable chromatographic purification process for recombinant adeno-asso- ciated virus (rAAV). J Gene Med 2(6):444-454.
26. Richieri SP, Bartholomew R, Aloia RC, Savary J, Gore R, Holt J, Ferre F, Musil R, Tian HR, Trauger R, et al. 1998. Characterization of highly purified, inactivated HIV-1 particles isolated by anion exchange chromatography. Vaccine 16(2-3):119-129.
27. Rodrigues T, Carvalho A, Roldao A, Carrondo MJ, Alves PM, Cruz PE. 2006. Screening anion-exchange chromatographic matrices for isolation ofonco-retroviral vectors. J Chromatogr B Analyt Technol Biomed Life Sci 837(1-2):59-68.
28. Shi L, Ho J, Norling LA, Roy M, Xu Y. 1999a. A real time quantitative PCR- based method for the detection and quantification of simian virus 40. Biologicals 27(3):241-252.
29. Shi L, Norling LA, Lau AS, Krejci S, Laney AJ, Xu Y. 1999b. Real time quantitative PCR as a method to evaluate simian virus 40 removal during pharmaceutical protein purification. Biologicals 27(3):253-262.
30. Shi L, Chen Q, Norling LA, Lau AS, Krejci S, Xu Y. 2004. Real time quantitative PCR as a method to evaluate xenotropic murine leukemia virus removal during pharmaceutical protein purification. Biotechnol Bioeng 87(7):884-896.
31. Stahlberg J. 1999. Retention models for ions in chromatography. J Chromatogr A 855(1):3-55.
32. Tayot JL, Tardy M, Gattel P, Cueille G, Liautaud J. 1987. Large scale use of Spherosil ion exchangers in plasma fractionation. Dev Biol Stand 67:15-24.
33. Trilisky EI, Lenhoff AM. 2007. Sorption processes in ion-exchange chro- matography of viruses. J Chromatogr A 1142(1):2-12.
34. Valera CR, Chen JW, Xu Y. 2003. Application of multivirus spike approach for viral clearance evaluation. Biotechnol Bioeng 84(6):714-722.
35. Wilson DE. 1962. Fractionation of Newcastle disease virus by chromato- graphy on diethylaminoethyl cellulose. J Bacteriol 84:295-301.
36. Yang H, Viera C, Fischer J, Etzel M. 2002. Purification of a large protein using ion-exchange membranes. Ind Eng Chem Res 41(6):1597-1602.
37. Zhan D, Roy MR, Valera C, Cardenas J, Vennari JC, Chen JW, Liu S. 2002. Detection of minute virus of mice using real time quantitative PCR in assessment of virus clearance during the purification of Mammalian cell substrate derived biotherapeutics. Biologicals 30(4):259-270.
38. Zolton RP, Padvelskis JV. 1984. Evaluation of an ion-exchange procedure for removal of hepatitis type B contamination from human gamma globulin products. Vox Sang 47(2):114-121.