A Novel, Q-PCR based approach to measuring endogenous retroviral clearance by capture protein a chromatography

Biotechnology and Bioengineering

Volumn 102, Issue 5, 2009, Pages 1438-1447

  Zhang, Min ^a   Lute, Scott ^b   Norling, Lenore ^a   Hong, Connie ^a   Safta, Aurelia ^a   O'Connor, Deborah ^a   Bernstein, Lisa J ^a   Wang, Hua ^a   Blank, Greg ^a   Brorson, Kurt ^b   Chen, Qi ^a  

^a GENENTECH INC   (United States)

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

Author keywords

CHO cells; Design space; Production scale; Protein A chromatography; Retrovirus like particles; Viral clearance

Indexed keywords

CHO CELLS; DESIGN SPACE; PRODUCTION SCALE; PROTEIN A CHROMATOGRAPHY; RETROVIRUS-LIKE PARTICLES; VIRAL CLEARANCE;

ASSAYS; CELL CULTURE; CHROMATOGRAPHIC ANALYSIS; COSMIC RAYS; DESIGN; ENZYME ACTIVITY; RESINS; STEELMAKING; VIRUSES;

CHROMATOGRAPHY;

PROTEIN A;

ANIMAL CELL; ARTICLE; CHROMATOGRAPHY; CLEARANCE; CONTROLLED STUDY; FLOW RATE; LIFE CYCLE; NONHUMAN; PROTEIN A CHROMATOGRAPHY; QUANTITATIVE ANALYSIS; RETROVIRUS; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; TEMPERATURE; VIRUS GENOME;

ANIMALS; CHO CELLS; CHROMATOGRAPHY, AFFINITY; CRICETINAE; CRICETULUS; DRUG CONTAMINATION; POLYMERASE CHAIN REACTION; RETROVIRIDAE; RNA, VIRAL; STAPHYLOCOCCAL PROTEIN A;

CRICETULUS GRISEUS; GAMMARETROVIRUS;

EID: 63549145150     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22172     Document Type: Article

References (34)

1. Adamson SR. 1998. Experiences of virus, retrovirus and retrovirus-like particles in Chinese hamster ovary (CHO) and hybridoma cells used for production of protein therapeutics. Dev Biol Stand 93:89-96.
2. Anderson KP, Lie YS, Low MA, Williams SR, Wurm FM, Dinowitz M. 1991a. Defective endogenous retrovirus-like sequences and particles of Chinese hamster ovary cells. Dev Biol Stand 75:123-132.
3. Anderson KP, Low MA, Lie YS, Keller GA, Dinowitz M. 1991b. Endogenous origin of defective retroviruslike particles from a recombinant Chinese hamster ovary cell line. Virology 181(1):305-311.
4. Bartal AH, Feit C, Erlandson R, Hirshaut Y. 1982. The presence of viral particles in hybridoma clones secreting monoclonal antibodies. N Engl J Med 306(23):1423.
5. Blumel J, Schmidt I, Willkommen H, Lower J. 2002. Inactivation of parvovirus B19 during pasteurization of human serum albumin. Transfusion 42(8):1011-1018.
6. Brorson K, De Wit C, Hamilton E, Mustafa M, Swann PG, Kiss R, Taticek R, Polastri G, Stein KE, Xu Y. 2002a. Impact of cell culture process changes on endogenous retrovirus expression. Biotechnol Bioeng 80(3):257- 267.
7. Brorson K, Xu Y, Swann PG, Hamilton E, Mustafa M, de Wit C, Norling LA, Stein KE. 2002b. Evaluation of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus in mAb cell-culture. Biolo- gicals30(l):15-26.
8. Brorson K, Brown J, Hamilton E, Stein KE. 2003a. Identification of protein A media performance attributes that can be monitored as surrogates for retrovirus clearance during extended re-use. J Chromatogr A 989(1): 155-163.
9. Brorson K, Krejci S, Lee K, Hamilton E, Stein K, Xu Y. 2003b. Bracketed generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins. Biotechnol Bioeng 82(3):32l-329.
10. Brorson K, Norling L, Hamilton E, Lute S, Lee K, Curtis S, Xu Y. 2004. Current and future approaches to ensure the viral safety of biophar- maceuticals. Dev Biol (Basel) 118:17-29.
11. CBER (Center for Biologies Evaluation and Research). 1997. Points to consider in the manufacture and testing of monoclonal antibody products for human use.
12. Celis P, Silvester G. 2004. European Regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products. Dev Biol (Basel) 118:3-10.
13. 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.
14. de Wit C, Fautz C, Xu Y. 2000. Real-time quantitative PCR for retrovirus- like particle quantification in CHO cell culture. Biologicals 28(3):137- 148.
15. Dinewitz M. 2002. Viral safety and clearance evaluation-Implications for process change and comparability. Dev Biol 109:121-126.
16. Dinowitz M, Lie YS, Low MA, Lazar R, Fautz C, Potts B, Sernatinger J, Anderson K. 1992. Recent studies on retrovirus-like particles in Chinese hamster ovary cells. Dev Biol Stand 76:201-207.
17. Donahue RE, Kessler SW, Bodine D, McDonagh K, Dunbar C, Goodman S, Agricola B, Byrne E, Raffeld M, Moen R, et al. 1992. Helper virus induced T cell lymphoma in nonhuman primates after retroviral mediated gene transfer. J Exp Med 176(4):1125-1135.
18. EMEA. 1996. Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the Inactivation and removal of viruses.
19. FDA. 2008. Current good manufacturing practice for finished pharmaceu- ticals Subpart E-Control of Components and Drug Product Contain- ers and Closures § 211.80 General requirements. (21 CFR 211.80). Rockville MD: Food And Drug Administration. Department of Health And Human Services.
20. Garnick RL. 1998. Raw materials as a source of contamination in large-scale cell culture. Dev Biol Stand 93:21-29.
21. ICH (International Conference on Harmonization). 1998. Q5A. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
22. ICH (International Conference on Harmonisation) Q8. 2006. Pharmaceu- tical Development.
23. Kim JP, Kaplan HS, Fry KE. 1982. Characterization of an infective molecular clone of the B-tropic, ecotropic BL/Ka(B) murine retrovirus genome. J Virol 44(l):217-225.
24. Lau AS, Lie YS, Norling LA, Sernatinger J, Dinowitz M, Petropoulos Cl, Xu Y. 1999. Quantitative competitive reverse transcription-PCR as a method to evaluate retrovirus removal during chromatography procedures. J Biotechnol 75(2-3):105-115.
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. Lubiniecki AS, Dinowitz M, Nelson E, Wiebe M, May L, Ogez J, Builder S, Lubiniecki AS, Dinowitz M, Nelson E, et al. 1989. Endogenous retro- viruses of continuous cell substrates. Dev Biol Stand 70:187-191.
27. Lute S, Norling L, Hanson M, Emery R, Stinson D, Padua K, Blank G, Chen Q, Brorson K. 2008. Robustness of virus removal by protein A chro- matography is independent of media lifetime. J Chromatography A 1205(l-2):17-25.
28. Moroni C, Schumann G. 1975. Lipopolysaccharide induces C-type virus in short term cultures of BALB/c spleen cells. Nature 254(5495):60-61.
29. PDA. 2005. PDA technical report no. 42: Process validation of protein manufacturing. Parenteral drug Association. PDA J Pharm Sci Technol 59(4 Suppl TR42):l-28.
30. Shepherd AJ, Wilson NJ, Smith KT. 2003. Characterisation of endogenous retrovirus in rodent cell lines used for production of biologicals. Biologicals 31(4):251-260.
31. 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.
32. Valdes R, Ibarra N, Ruibal I, Beldarrain A, Noa E, Herrera N, Aleman R, Padilla S, Garcia J, Perez M, et al. 2002. Chromatographic removal combined with heat, acid and chaotropic Inactivation of four model viruses. J Biotechnol 96(3):251-258.
33. Valera CR, Chen JW, Xu Y. 2003. Application of multivirus spike approach for wal clearance evaluation. Biotechnol Bioeng 84(6):714-722.
34. Xu Y, Brorson K. 2003. An overview of quantitative PCR assays for biologicals: Quality and safety evaluation. Dev Biol (Basel) 113:89-98.