Design of salt-tolerant membrane adsorbers for viral clearance

Biotechnology and Bioengineering

Volumn 103, Issue 5, 2009, Pages 920-929

  Riordan, William ^a   Heilmann, Steve ^b   Brorson, Kurt ^c   Seshadri, Kannan ^b   He, Yi ^b   Etzel, Mark ^a  

^a University of Wisconsin Madison   (United States)

^b 3M COMPANY   (United States)

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

Author keywords

X174; Anion exchange chromatography; Membrane adsorbers; Monoclonal antibodies; Salt tolerant ligands; Viral clearance

Indexed keywords

ADSORBERS; AGMATINE; ANION EXCHANGE; ANION EXCHANGE CHROMATOGRAPHY; ANION EXCHANGE MEMBRANE; BIOLOGICAL THERAPEUTICS; BUFFER SALTS; DOWNSTREAM-PROCESSING; ISO-ELECTRIC POINTS; LIGAND BINDING; LIGAND CHEMISTRY; LIGAND IMMOBILIZATION; LOG REDUCTION VALUES; NET CHARGES; POLYETHYLENEIMINE; POLYHEXAMETHYLENE BIGUANIDE; PROCESSING STEPS; QUATERNARY AMINES; SALT TOLERANCE; SALT TOLERANT; SALT TOLERANT LIGANDS; STRONG ANION EXCHANGES; STRONG ANION-EXCHANGE CHROMATOGRAPHY; VIRAL CLEARANCE;

ADSORPTION; AMINES; CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; MEMBRANES; MONOCLONAL ANTIBODIES; NEGATIVE IONS; ORGANIC COMPOUNDS; SURFACE PLASMON RESONANCE;

LIGANDS;

AGMATINE; POLY(HEXAMETHYLENEBIGUANIDE); POLYETHYLENEIMINE; SODIUM CHLORIDE;

ANION EXCHANGE; ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; BACTERIOPHAGE; CHEMICAL STRUCTURE; CONTROLLED STUDY; DOWNSTREAM PROCESSING; ISOELECTRIC POINT; LIGAND BINDING; SALT TOLERANCE; VIRUS ATTACHMENT;

ANTIBODIES, MONOCLONAL; BACTERIOPHAGE PHI X 174; FILTRATION; MICROPORE FILTERS; SALTS;

EID: 67650828869     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22314     Document Type: Article

References (33)

1. Avramescu M, Borneman Z, Wessling M. 2003. Dynamic behavior of adsorber membranes for protein recovery. Biotechnol Bioeng 84: 564-572. (Pubitemid 37356378)
2. Boi C. 2007. Membrane adsorbers as purification tools for monoclonal antibody purification. J Chromatogr B 848:19-27. (Pubitemid 46367765)
3. Borneman S, Wessling M. 2006. Enzyme capturing and concentration with mixed matrix membrane adsorbers. J Membr Sci 280:406-417.
4. Burton S, Harding D. 1997. High-density ligand attachment to brominated allyl matrices and application to mixed mode chromatography of chymosin. J Chromatogr A 775:39-50. (Pubitemid 27303873)
5. 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 84:179-186. (Pubitemid 37176329)
6. Drtina G, Haddad L, Rasmussen J, Gaddam B, Williams M, Moeller S, Fitzsimons R, Fansler D, Buhl T, Yang Y, Weller V, Lee J, Beauchamp T, Heilmann S. 2005. Azlactone-reactive polymer supports for immobilizing synthetically useful enzymes. II. Important preliminary hydrogen bonding effects in the covalent coupling of Penicillin G Acylase. React Funct Polym 64:13-24.
7. Endres HN, Johnson JA, Ross CA, Welp JK, Etzel MR. 2003. Evaluation of an ion-exchange membrane for the purification of plasmid DNA. Biotechnol Appl Biochem 37:259-266. (Pubitemid 36713033)
8. Etzel MR. 2003. Layered stacks. In: Svec F, et al. editors. Monolithic materials: Preparation, properties, and applications. Amsterdam: Elsevier Science. p. 213-234.
9. Ghosh R. 2002. Protein separation using membrane chromatography: Opportunities and challenges. J Chromatogr A 952:13-27. (Pubitemid 34266868)
10. Giovannini R, Freitag R. 1998. High-performance membrane chromatography of supercoiled plasmid DNA. Anal Chem 70:3348-3354. (Pubitemid 128500046)
11. Haber C, Skupsky J, Lee A, Lander R. 2004. Membrane chromatography of DNA: Conformation-induced capacity and selectivity. Biotechnol Bioeng 88:26-34. (Pubitemid 39388690)
12. Haggerty L, Lenhoff A. 1991. Relation of protein electrostatics computations to ion-exchange and electrophoretic behavior. J Phys Chem 95: 1472.
13. Han B, Specht R, Wickramasinghe S, Carlson J. 2005. Binding Aedes aegypti densonucleosis virus to ion exchange membranes. J Chromatogr A 1092:114-1124. (Pubitemid 41356537)
14. Haughney H, Aranha H. 2003. Disposable processing gains you a competitive edge. Biopharm Int 16:50.
15. International Conference for Harmonization (ICH). 1998. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Q5A. International Conference for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, Switzerland.
16. Johansson B, Belew M, Eriksson S, Glad G, Lind O, Maloisel J, Norrman N. 2003. Preparation and characterization of prototypes for multimodal separation media aimed at the capture of negatively charged biomolecules at high salt conditions. J Chromatogr A 1016: 21-33. (Pubitemid 37123190)
17. Kalbfuss B, Wolff M, Geisler L, Tappe A, Wickramasinghe R, Thom V, Reichl U. 2007. Direct capture of influenza A virus from cell culture supernatant with Sartobind anion-exchange membrane adsorbers. J Membr Sci 299:251-260. (Pubitemid 46962913)
18. Knudsen HL, Fahrner RL, Xu Y, Norling LA, Blank GS. 2001. Membrane ion-exchange chromatography for process-scale antibody purification. J Chromatogr A 907:145-154. (Pubitemid 32057007)
19. Lute S, Aranha H, Tremblay D, Liang D, Ackermann H, Chu B, Moineau S, Brorson K. 2004. Characterization of coliphage PR772 and evaluation of its use for virus filter performance testing. Appl Environ Microbiol 70:4864-4871. (Pubitemid 39095515)
20. Lute S, Bailey M, Combs J, Sukumar M, Brorson K. 2007. Phage passage after extended processing in small-virus-retentive filters. Biotechnol Appl Biochem 47:141-151. (Pubitemid 47218247)
21. Nakada Y, Itoh Y. 2003. Identification of the putrescine biosynthetic genes in Pseudomonas aeruginosa and characterization of agmatine deiminase and N-carbamoylputrescine amidohydrolase of the arginine decarboxylase pathway. Microbiology 149:707-714. (Pubitemid 36395105)
22. O'Leary R, Feuerhelm D, Peers D, Xu Y, Blank GS. 2001. Determining the useful lifetime of chromatography resins: Prospective small-scale studies. BioPharm 14:10-18. (Pubitemid 32911442)
23. Phillips M, Cormier J, Ferrence J, Dowd C, Kiss R, Lutz H, Carter J. 2005. Performance of a membrane adsorber for trace impurity removal in biotechnology manufacturing. J Chromatogr A 1078:74-82. (Pubitemid 40813101)
24. Roth C, Unger K, Lenhoff A. 1996. Mechanistic model of retention in protein ion-exchange chromatography. J Chromatogr A 726:45-56. (Pubitemid 26081685)
25. Rothbard JB, Jessop TC, Wender PA. 2005. Adaptive translocation: The role of hydrogen bonding and membrane potential in the uptake of guanidinium-rich transporters into cells. Adv Drug Deliv Rev 57: 495-504.
26. Splitt H, Mackenstedt I, Freitag R. 1996. Preparative membrane adsorber chromatography for the isolation of cow milk components. J Chromatogr A 729:87-97. (Pubitemid 26135007)
27. Stahlberg J. 1999. Retention models for ions in chromatography. J Chromatogr A 855:3-55.
28. Suck K, Walter J, Menzel F, Tappe A, Kasper C, Naumann C, Zeidler R, Scheper T. 2006. Fast and efficient protein purification using membrane adsorber systems. J Biotechnol 121:361-367. (Pubitemid 43113109)
29. Teeters MA, Conrardy SE, Thomas BL, Root TW, Lightfoot EN. 2003. Adsorptive membrane chromatography for purification of plasmid DNA. J Chromatogr A 989:165-173. (Pubitemid 36197824)
30. Warner TN, Nochumson S. 2003. Rethinking the economics of chromatography: New technologies and hidden costs. Biopharm Int 16:58-60. (Pubitemid 36330098)
31. Yang H, Viera C, Fischer J, Etzel MR. 2002. Purification of a large protein using ion-exchange membranes. Ind Eng Chem Res 41:1597-1602. (Pubitemid 34225923)
32. Zhou JX, Tressel T. 2006. Basic concepts in Q membrane chromatography for large-scale antibody production. Biotechnol Prog 22:341-349.
33. Zhou J, Tressel T, Gottschalk U, Solamo F, Pastor A, Dermawan S, Hong T, Reif O, Mora J, Hutchinson F, Murphy M. 2006. New Q membrane scale-down model for process-scale antibody purification. J Chromatogr A 1134:66-73. (Pubitemid 44633924)