Understanding the mechanism of virus removal by Q sepharose fast flow chromatography during the purification of CHO-cell derived biotherapeutics

Biotechnology and Bioengineering

Volumn 104, Issue 2, 2009, Pages 371-380

  Strauss, Daniel M ^a,d   Lute, Scott ^b   Tebaykina, Zinaida ^a,e   Frey, Douglas D ^c   Ho, Cintia ^a   Blank, Gregory S ^a   Brorson, Kurt ^b   Chen, Qi ^a   Yang, Bin ^a  

^a GENENTECH INC   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c University of Marylandw Baltimore County   (United States)

^d ELI LILLY AND COMPANY   (United States)

^e UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Anion exchange chromatography (AEX); Chromatofocusing; Q sepharose fast flow (QSFF); Viral clearance; Virus chromatography

Indexed keywords

ANION EXCHANGE CHROMATOGRAPHY; ANION EXCHANGE CHROMATOGRAPHY (AEX); BINDING PROFILES; BIOTECHNOLOGY PRODUCTS; BIOTHERAPEUTICS; CHROMATOFOCUSING; CHROMATOGRAPHY RESIN; ELECTROSTATIC INTERACTIONS; HIGH SALT CONCENTRATION; ISO-ELECTRIC POINTS; MAMMALIAN CELL CULTURE; POSITIVELY CHARGED; PROCESS VALIDATION; Q SEPHAROSE FAST FLOW (QSFF); Q-SEPHAROSE; THERAPEUTIC MONOCLONAL ANTIBODIES; VIRAL CLEARANCE; VIRUS REMOVAL;

ANIMAL CELL CULTURE; CELL CULTURE; CELL MEMBRANES; CHROMATOGRAPHY; ELECTROSTATICS; GEL PERMEATION CHROMATOGRAPHY; IMPURITIES; IONS; MAMMALS; MICROORGANISMS; MONOCLONAL ANTIBODIES; PURIFICATION; RESINS; SALT REMOVAL; STRATEGIC PLANNING;

CHROMATOGRAPHIC ANALYSIS;

COAT PROTEIN; MONOCLONAL ANTIBODY; VIRUS DNA; VIRUS PROTEIN;

ANIMAL CELL; ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; BACTERIOPHAGE; BIOTECHNOLOGY; CELL CULTURE; CHO CELL; CHROMATOFOCUSING; CHROMATOGRAPHY; DRUG PURITY; DRUG SAFETY; ISOELECTRIC POINT; MAMMAL CELL; MURINE LEUKEMIA VIRUS; NONHUMAN; Q SEPHAROSE FAST FLOW CHROMATOGRAPHY; REAL TIME POLYMERASE CHAIN REACTION; SIMIAN VIRUS 40; VIRAL CLEARANCE; VIRAL CONTAMINATION; VIRUS CHROMATOGRAPHY; VIRUS PARTICLE; VIRUS REDUCTION;

ANIMALS; ANTIBODIES, MONOCLONAL; CHO CELLS; CHROMATOGRAPHY, AGAROSE; CRICETINAE; CRICETULUS; CULTURE MEDIA; VIRUS ATTACHMENT; VIRUSES;

MAMMALIA;

EID: 70349329558     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22416     Document Type: Article

References (49)

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 Biochem 28(Pt 1):85-94. (Pubitemid 28369910)
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. (Pubitemid 30398355)
4. Boschetti N, Niederhauser I, Kempf C, Stuhler A, Lower J, Blumel J. 2004. Different susceptibility of B19 virus and mice minute virus to low pH treatment. Transfusion 44(7):1079-1086. (Pubitemid 38823816)
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. (Pubitemid 35221623)
6. Brorson K, Shen H, Lute S, Perez JS, Frey DD. 2008. Characterization and purification of bacteriophages using chromatofocusing. J Chromatogr A 1207(1-2):110-121.
7. Burnouf T. 1995. Chromatography in plasma fractionation: Benefits and future trends. J Chromatogr B Biomed Appl 664(1):3-15.
8. Burova E, Ioffe E. 2005. Chromatographic purification of recombinant adenoviral and adeno-associated viral vectors: Methods and implications. Gene Ther 12 (Suppl 1): S5-S17. (Pubitemid 41541749)
9. 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. (Pubitemid 28039618)
10. CBER (Center for Biologics Evaluation and Research, Federal Drug Administration). 1997. Points to consider in the manufacture and testing of monoclonal antibody products for human use (http://www.fda.gov/downloads/ BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ OtherRecommendationsforManufacturers/UCM153182.pdf).
11. Chen W, Liu Z, Lin P, Fang C, Yamamoto S. 2007. The hydrophobic interactions of the ion-exchanger resin ligands with proteins at high salt concentrations by adsorption isotherms and isothermal titration calorimetry. Separation Purif Technol 54:212-219. (Pubitemid 46228030)
12. 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. (Pubitemid 37176329)
13. EMEA (European Medicines Agency). 2008. Guideline on virus safety evaluation of biotechnological investigational medicinal products (http://www.emea.europa.eu/pdfs/human/bwp/39849805enfin.pdf).
14. 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. (Pubitemid 32778004)
15. Farrah SR, Shah DO, Ingram LO. 1981. Effects of chaotropic and antichaotropic agents on elution of poliovirus adsorbed on membrane filters. Proc Natl Acad Sci USA 78(2):1229-1232.
16. Garnick RL. 1996. Experience with viral contamination in cell culture. Dev Biol Stand 88:49-56.
17. Gerba CP. 1984. Applied and theoretical aspects of virus adsorption to surfaces. Adv Appl Microbiol 30:133-168.
18. Harrison SC. 2001. Principles of virus structure. In: Knipe DM, Howley PM, editors. Fields virology, 4th edn. Philadelphia, PA: Lippincott Williams and Wilkins. p 53-85.
19. Herzer S, Beckett P, Wegman T, Moore P. 2003. Isoelectric titration curves of viral particles as an evaluation tool for ion exchange chromatography. Life Science News (GE Healthcare) 13:16-18.
20. ICH (International Conference on Harmonization). 1999. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin (http://www.ich.org/cache/compo/363-272-1.html #Q5A).
21. 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. (Pubitemid 46479556)
22. 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.
23. Kopaciewicz W, Rounds MA, Fausnaugh J, Regnier FE. 1983. Retention model for high-performance ion-exchange chromatography. J Chromatogr 266:3-21.
24. Ladiwala A, Rege K, Breneman CM, Cramer SM. 2005. A priori prediction of adsorption isotherm parameters and chromatographic behavior in ion-exchange systems. Proc Natl Acad Sci USA 102(33):11710-11715. (Pubitemid 41170791)
25. Lieber MM, Benveniste RE, Livingston DM, Todaro GJ. 1973. Mammalian cells in culture frequently release type C viruses. Science 182(107):56-59.
26. 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 chromatography media on virus removal. J Chromatogr A 1069(1):79-89. (Pubitemid 40380629)
27. PDA (Parenteral Drug Association). 2008. PDA technical report #41: Virus filtration. PDA J Pharm Sci Technol 62:1-58.
28. Richieri SP, Bartholomew R, Aloia RC, Savary J, Gore R, Holt J, Ferre F, Musil R, Tian HR, Trauger R, Lowry P, Jensen F, Carlo DJ, Maigetter RZ, Prior CP. 1998. Characterization of highly purified, inactivated HIV-1 particles isolated by anion exchange chromatography. Vaccine 16(2-3):119-129. (Pubitemid 27520987)
29. Rodrigues T, Carvalho A, Roldao A, Carrondo MJ, Alves PM, Cruz PE. 2006. Screening anion-exchange chromatographic matrices for isolation of onco-retroviral vectors. J Chromatogr B Analyt Technol Biomed Life Sci 837(1-2):59-68. (Pubitemid 43783316)
30. Rodrigues T, Carrondo MJ, Alves PM, Cruz PE. 2007. Purification of retroviral vectors for clinical application: Biological implications and technological challenges. J Biotechnol 127(3):520-541. (Pubitemid 44827399)
31. Shen H, Frey DD. 2004. Charge regulation in protein ion-exchange chromatography: Development and experimental evaluation of a theory based on hydrogen ion Donnan equilibrium. J Chromatogr A 1034(1-2):55-68. (Pubitemid 38379682)
32. 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. (Pubitemid 30077325)
33. 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. (Pubitemid 30077326)
34. 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. (Pubitemid 39265085)
35. Shields PA, Farrah SR. 1983. Influence of salts on electrostatic interactions between poliovirus and membrane filters. Appl Environ Microbiol 45(2):526-531.
36. Sluyterman LAA, Elgersma O. 1978. Chromatofocusing: Isoelectric focusing on ion-exchange columns: I. General principals. J Chromatogr A 150(1):17-30.
37. Strauss DM, Gorrell J, Plancarte M, Blank GS, Chen Q, Yang B. 2009. Anion exchange chromatography provides a robust, predictable process to ensure viral safety of biotechnology products. Biotechnol Bioeng 102(1):168-175.
38. 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.
39. Trilisky EI, Lenhoff AM. 2007. Sorption processes in ion-exchange chromatography of viruses. J Chromatogr A 1142(1):2-12.
40. Valera CR, Chen JW, Xu Y. 2003. Application of multivirus spike approach for viral clearance evaluation. Biotechnol Bioeng 84(6):714-722. (Pubitemid 37420343)
41. Weichert WS, Parker JS, Wahid AT, Chang SF, Meier E, Parrish CR. 1998. Assaying for structural variation in the parvovirus capsid and its role in infection. Virology 250(1):106-117. (Pubitemid 28471767)
42. Yamada K, McCarty DM, Madden VJ, Walsh CE. 2003. Lentivirus vector purification using anion exchange HPLC leads to improved gene transfer. Biotechniques 34(5):1074-1078, 1080. (Pubitemid 36554576)
43. Yamamoto S, Miyagawa E. 1999. Retention behavior of very large biomolecules in ion-exchange chromatography. J Chromatogr A 852(1):25-30. (Pubitemid 29347052)
44. 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. (Pubitemid 34225923)
45. Yao Y, Lenhoff AM. 2006. Pore size distributions of ion exchangers and relation to protein binding capacity. J Chromatogr A 1126(1-2):107-119. (Pubitemid 44278811)
46. Zerda KS, Gerba CP. 1984. Agarose isoelectrofocusing of intact virions. J Virol Methods 9(1):1-6.
47. 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. (Pubitemid 36268961)
48. Zolotukhin S, Potter M, Zolotukhin I, Sakai Y, Loiler S, Fraites TJ, Jr., Chiodo VA, Phillipsberg T, Muzyczka N, Hauswirth WW, Flotte TR, Byrne BJ, Snyder RO. 2002. Production and purification of serotype 1, 2 and 5 recombinant adeno-associated viral vectors. Methods 28(2):158-167. (Pubitemid 35341079)
49. 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.