Strategies for developing design spaces for viral clearance by anion exchange chromatography during monoclonal antibody production

Biotechnology Progress

Volumn 26, Issue 3, 2010, Pages 750-755

  Strauss, Daniel M ^a,b   Cano, Tony ^a   Cai, Nick ^a   Delucchi, Heather ^a   Plancarte, Magdalena ^a   Coleman, Daniel ^a   Blank, Gregory S ^a   Chen, Qi ^a   Yang, Bin ^a  

^a GENENTECH INC   (United States)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

Anion exchange chromatography (AEX); Design of experiments (DOE); Design space; Quality by design (QbD); Viral clearance

Indexed keywords

ANION EXCHANGE CHROMATOGRAPHY; COMPLEX NATURE; CRITICAL QUALITY; DESIGN SPACES; ENDOGENOUS RETROVIRUS; FACTORIAL EXPERIMENT; FULL FACTORIAL DESIGN; GENERAL APPROACH; MANUFACTURING PROCESS; MECHANISM OF ACTION; MONOCLONAL ANTIBODY PRODUCTION; MULTIDIMENSIONAL EFFECTS; PROCESS PARAMETERS; PROCESS VARIABLES; PRODUCTION PROCESS; QUALITY BY DESIGNS; REGULATORY INITIATIVES; THERAPEUTIC PRODUCTS; VIRAL CLEARANCE; VIRUS REMOVAL;

ALLERGIES; CHROMATOGRAPHY; DESIGN OF EXPERIMENTS; IMPURITIES; IONS; MERGERS AND ACQUISITIONS; MONOCLONAL ANTIBODIES; PRODUCTION ENGINEERING; RISK ASSESSMENT; RISK MANAGEMENT; STRATEGIC PLANNING; SURFACE PLASMON RESONANCE; VIRUSES;

PROCESS DESIGN;

MONOCLONAL ANTIBODY;

ANIMAL; ARTICLE; BIOSYNTHESIS; CHEMISTRY; CHO CELL; CRICETULUS; CULTURE TECHNIQUE; HAMSTER; ION EXCHANGE CHROMATOGRAPHY; ISOLATION AND PURIFICATION; METHODOLOGY; RISK ASSESSMENT; VIRUS; CHO CELL LINE; PROCEDURES;

ANIMALS; ANTIBODIES, MONOCLONAL; CELL CULTURE TECHNIQUES; CHO CELLS; CHROMATOGRAPHY, ION EXCHANGE; CRICETINAE; CRICETULUS; RESEARCH DESIGN; RISK ASSESSMENT; VIRUSES;

EID: 77954721025     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.385     Document Type: Article

References (21)

1. ICH (International Conference on Harmonization). Pharmaceutical Development Revision 1 Q8 (R1). Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory-Information/Guidances/ucm073507.pdf; 2009.
2. Harms J, Xiangyang W, Kim T, Yang X, Rathore AS. Defining process design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol Prog. 2008;24:655-662.
3. Li F, Hashimura Y, Pendleton R, Harms J, Collins E, Lee B. A systematic approach for scale-down model development and characterization of commercial cell culture processes. Biotechnol Prog. 2006;22:696-703.
4. Nail SL, Searles JA. Elements of quality by design in development and scale-up of freeze-dried parenterals. BioPharm Int. 2008.
5. Anderson KP, Low MA, Lie YS, Keller GA, Dinowitz M. Endogenous origin of defective retrovirus like particles from a recombinant Chinese hamster ovary cell line. Virology. 1991; 181:305-311.
6. Brorson K, de Wit C, Hamilton E, Mustafa M, Swann PG, Kiss R, Taticek R, Polastri G, Stein KE, Xu Y. Impact of cell culture process changes on endogenous retrovirus expression. Biotechnol Bioeng. 2002;80:257-267.
7. Lieber MM, Benveniste RE, Livingston DM, Todaro GJ. Mammalian cells in culture frequently release type C viruses. Science. 1973;182:56-59.
8. Garnick RL. Experience with viral contamination in cell culture. Dev Biol Stand. 1996;88:49-56.
9. CBER(Center for Biologics Evaluation and Research, Federal Drug Administration). Points to consider in the manufacture and testing of monoclonal antibody products for human use. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/UCM153182.pdf; 1997.
10. EMEA(European Medicines Agency). Guideline on virus safety evaluation of biotechnological investigational medicinal products. Available at: http://www.emea.europa.eu/pdfs/human/bwp/39849805enfin.pdf; 2008.
11. ICH(International Conference on Harmonization). Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073454.pdf; 1999.
12. Norling L, Lute S, Emery R, Khuu W, Voisard M, Xu Y, Chen Q, Blank G, Brorson K. Impact of multiple re-use of anionexchange chromatography media on virus removal. J Chromatogr A. 2005;1069:79-89.
13. Shi L, Chen Q, Norling LA, Lau AS, Krejci S, Xu Y. Real time quantitative PCR as a method to evaluate xenotropic murine leukemia virus removal during pharmaceutical protein purification. Biotechnol Bioeng. 2004;87:884-896.
14. Strauss DM, Lute S, Brorson K, Blank GS, Chen Q, Yang B. Removal of endogenous retrovirus-like particles from CHO-cell derived products using Q sepharose fast flow chromatography. Biotechnol Prog. 2009;25:1194-1197.
15. Curtis S, Lee K, Blank GS, Brorson K, Xu Y. Generic/matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mode. Biotechnol Bioeng. 2003;84:179-186.
16. Strauss DM, Gorrell J, Plancarte M, Blank GS, Chen Q, Yang B. Anion exchange chromatography provides a robust, predictable process to ensure viral safety of biotechnology products. Biotechnol Bioeng. 2009;102:168-175.
17. De Wit C, Fautz C, Xu Y. Real-time quantitative PCR for retrovirus-like particle quantification in CHO cell culture. Biologicals. 2000;28:137-148.
18. Shi L, Ho J, Norling LA, Roy M, Xu Y. A real time quantitative PCR-based method for the detection and quantification of simian virus 40. Biologicals. 1999;27:241-252.
19. Zhan D, Roy MR, Valera C, Cardenas J, Vennari JC, Chen JW, Liu S. 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. 2002;30:259-270.
20. Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerhelm D, Vanderlaan M, Blank GS. Industrial purification of pharmaceutical antibodies: development, operation, and validation of chromatography processes. Biotechnol Genet Eng Rev. 2001;18:301-327.
21. Strauss DM, Lute S, Tebaykina Z, Frey DD, Ho C, Blank GS, Brorson K, Chen Q, Yang B. Understanding the mechanism of virus removal by Q sepharose fast flow chromatography during the purification of CHO-cell derived biotherapeutics. Biotechnol Bioeng. 2009;104:371-380.