Viral clearance using disposable systems in monoclonal antibody commercial downstream processing

Biotechnology and Bioengineering

Volumn 100, Issue 3, 2008, Pages 488-496

  Zhou, Joe X ^a   Solamo, Felix ^a   Hong, Tony ^a   Shearer, Michael ^a   Tressel, Tim ^a  

^a AMGEN INC   (United States)

Author keywords

20 nm filtration; Depth filtration; Disposable system; Flux decay; Mice minute virus; Monoclonal antibody purification; Murine leukemia virus; Pseudorabies virus; Q membrane chromatography; Reo type 3 virus; Viral clearance

Indexed keywords

ANTIBODIES; CELL MEMBRANES; CHEMICALS; CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; COMPUTER NETWORKS; COST ACCOUNTING; DIGITAL SIGNAL PROCESSING; FILTRATION; IMPURITIES; MICROFILTRATION; MONOCLONAL ANTIBODIES; POLISHING; POROUS MATERIALS; TECHNOLOGY;

COMMERCIAL PROCESS; COST ANALYSIS; DATA SETS; DEPTH FILTRATION; DOWNSTREAM PROCESSING; FILTRATION TECHNOLOGIES; HOST CELLS; MEMBRANE CHROMATOGRAPHY; POLISHING STEPS; PRODUCT PURITY; PROTEIN A; TRACE AMOUNTS; VIRAL CLEARANCE;

COLUMN CHROMATOGRAPHY;

MONOCLONAL ANTIBODY;

ARTICLE; COLUMN CHROMATOGRAPHY; DISPOSABLE EQUIPMENT; MURINE LEUKEMIA VIRUS; PARVOVIRUS; PH MEASUREMENT; PROTEIN PROCESSING; PSEUDORABIES HERPETOVIRUS; VIRAL CONTAMINATION; VIRUS LOAD; ANIMAL; BIOSYNTHESIS; BIOTECHNOLOGY; CHROMATOGRAPHY; COST; DRUG CONTAMINATION; ECONOMICS; FILTRATION; HUMAN; INSTRUMENTATION; ISOLATION AND PURIFICATION; METHODOLOGY; PH; PRESSURE; TEMPERATURE; UTILIZATION REVIEW; VIRUS;

MINUTE VIRUS OF MICE; MURINE LEUKEMIA VIRUS; SUID HERPESVIRUS 1;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOTECHNOLOGY; CHROMATOGRAPHY; COSTS AND COST ANALYSIS; DISPOSABLE EQUIPMENT; DRUG CONTAMINATION; FILTRATION; HUMANS; HYDROGEN-ION CONCENTRATION; PRESSURE; TEMPERATURE; VIRUSES;

EID: 44049108746     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.21781     Document Type: Article

References (27)

1. Anon. 1994. Anforderungen an Validierungsstudien zum Nachweis der Virussicherheit von Arzneimitteln aus menschlichem Blut oder Plasma. Bundesgesundheitsamt und Paul-Ehrilich-Institut vom 04.05.1994: 4742-4744.
2. Anon. 1996. Note for Guidance on virus validation studies. CPMP/BWP/268/95 Final version 2.
3. Anon. 2001. Note for guidance on plasma derived medicinal products. CPMP/BWP/269/95 Revision 3.
4. Arunakumari A, Wang J, Ferreira G. 2007. Improved downstream process design for human monoclonal antibody production. BioPharm Int vol. 5, Supplement to February Issue: 36-40.
5. Bray J, Brattle K. 2004. In: Subramanian G, editor. Monoclonal antibody production: Minimising virus safety issues. New York: Plenum Publishers. 199-225 p.
6. Chadd HE, Chamow SM. 2001. Therapeutic antibody expression technology. Curr Opin Biotechnol 12:188-194.
7. Chu L, Robinson DK. 2001. Industrial choices for protein production by large-scale cell culture. Curr Opin Biotechnol 12:180-187.
8. Daemmrich A, Browden ME. 2005. A rising drug industry. Chem Eng News 83:28-42.
9. Fahrner RL. 2001. Industrial purification of pharmaceutical antibodies: Development, operation, and validation of chromatography process. Biotechnol Genet Eng Rev 18:301-327.
10. Fahrner RL, Blank GS. 1999. Real-time control of antibody loading during protein A affinity chromatography using an on-line assay. J Chromatogr A 849(1):191-196.
11. Fahrner RL, Whitney DH, Vanderlaan M, Blank GS. 1999. Performance comparison of protein A affinity-chromatography sorbents for purifying recombinant monoclonal antibodies. Biotechnol Appl Biochem 30 (Pt 2): 121-128.
12. Ikuta K, Luftig R. 1987. Differences in the pI heterogeneity of virion and intracellular Moloney murine leukaemia virus p30s. J Gen Virol 68: 487-498.
13. Karber G. 1931. Beitrag zu kolleltiven Behandlung pharmakologischer Reihenversuche. Naunyn Schmiedeberg's Arch. Exp Path Pharmak 152:380-390.
14. Shi L, Chen Q, Norling LA, Lau ASL, 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.
15. Singer V, Jones L, Yue S, Haugland R. 1997. Characterization of PicoGreen reagent and development of a fluorescence-based solution assay for double-stranded DNA quantitation. Anal Biochem 249(2):228-238.
16. Spearmann C. 1908. The method of "right or wrong cases" (constant stimuli) without Gauss's formulae. Br J Psychol 2:227-238.
17. Tipton B, Boose JA, Larsen W, Beck J, O'Brien T. 2002. Retrovirus and parvovirus clearance from an affinity column product using adsorptive depth filtration. BioPharm 15:43-50.
18. Walsh G. 2005. Biopharmaceuticals: Approvals and approval trends in 2004. BioPharm Int 18(5):58-65.
19. Weichen WS, Parker JSL, Wahid ATM, Chang S-F, Meier E, Parrish CR. 1998. Assaying for structural variation in the parvovirus capsid and its role in infection. Virology 250(1):106-117.
20. Williams PP, Pirtle EC, Coria MF. 1982. Isoelectric focusing of infectious particles of porcine Pseudorabies virus strains in granulated dextran gels. Can J Comp Med 46:65-69.
21. Yuan W, Parrish CR. 2001. Canine parvovirus capsid assembly and differences in mammalian and insect cells. Virology 279:546-557.
22. Zhou J, Dehghani H. 2006. Viral clearance: Innovative versus classical methods - Theoretical & practical concerns. Am Pharm Rev 9(5):74-82.
23. Zhou J, Dehghani H. 2007. Development of viral clearance strategies for large-scale monoclonal antibody production. In: Langer ES, editor. Advances in large scale BioManufacturing and scale-up production. Rockville, MD: ASM Press/BioPlan Associates, Inc. p 558-586.
24. Zhou J, Tressel T. 2005. Q membrane chromatography as a robust purification unit for large-scale antibody production. Bioprocess Int 3(9):32-37.
25. Zhou J, Tressel T. 2006. Basic concepts in Q membrane chromatography for large-scale antibody production. Biotechnol Prog 22(2):341-349.
26. Zhou J, Tressel T, Gottschalk U, Solamo F, Pastor A, Dermawan S, Hong T, Reif O, Mora J, Hutchison F, and others. 2006. A new Q membrane scale-down model for process-scale antibody purification. J Chromatogr A 1134:66-73.
27. Zhou J, Tressel T, Hong T, Feng L, Yang X, Lee B. 2007. Optimization of antibody processing: Upstream and downstream. In: Langer ES, editor. Advances in large scale BioManufacturing and scale-up production, 2nd edn. Rockville, MD: ASM Press/BioPlan Associates, Inc. p 478-516.