Clarification and capture of high-concentration refold pools for E. coli-based therapeutics using expanded bed adsorption chromatography

Biotechnology Progress

Volumn 30, Issue 1, 2014, Pages 113-123

  Xu, Xuankuo ^a   Hirpara, Jeet ^a,b   Epting, Kevin ^a,c   Jin, Mi ^a   Ghose, Sanchayita ^a,d   Rieble, Siegfried ^a   Li, Zheng Jian ^a  

^a BRISTOL MYERS SQUIBB COMPANY   (United States)

^b ROCHESTER INSTITUTE OF TECHNOLOGY   (United States)

^c SARTORIUS STEDIM BIOTECH GMBH   (Germany)

^d BIOGEN   (United States)

Author keywords

Capture; Clarification; Expanded bed adsorption chromatography; Filtration; High concentration refold pools; Inclusion body refolding; Protein precipitates

Indexed keywords

CAPTURE; CATION EXCHANGE CHROMATOGRAPHY; EXPANDED BED ADSORPTION; HIGH-CONCENTRATION REFOLD POOLS; IMPURITY CLEARANCES; INCLUSION BODY REFOLDING; PROTEIN CONCENTRATIONS; PROTEIN PRECIPITATION;

CLARIFIERS; COLUMN CHROMATOGRAPHY; ESCHERICHIA COLI; FILTRATION; LAKES; PACKED BEDS; PROTEINS; RESINS;

CLARIFICATION;

ESCHERICHIA COLI;

RECOMBINANT PROTEIN;

ADSORPTION; AFFINITY CHROMATOGRAPHY; ARTICLE; BIOTECHNOLOGY; CAPTURE; CHEMISTRY; CLARIFICATION; EQUIPMENT; ESCHERICHIA COLI; EXPANDED BED CHROMATOGRAPHY; FILTRATION; HIGH-CONCENTRATION REFOLD POOLS; INCLUSION BODY REFOLDING; ISOLATION AND PURIFICATION; METABOLISM; METHODOLOGY; PROTEIN PRECIPITATES; PROTEIN REFOLDING;

CAPTURE; CLARIFICATION; EXPANDED BED ADSORPTION CHROMATOGRAPHY; FILTRATION; HIGH-CONCENTRATION REFOLD POOLS; INCLUSION BODY REFOLDING; PROTEIN PRECIPITATES;

ADSORPTION; BIOTECHNOLOGY; CHROMATOGRAPHY, AFFINITY; ESCHERICHIA COLI; FILTRATION; PROTEIN REFOLDING; RECOMBINANT PROTEINS;

EID: 84893797452     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1833     Document Type: Article

References (79)

1. Lilie H, Schwarz E, Rudolph R. Advances in refolding of protein produced in E. coli. Curr Opin Biotechnol. 1998;9:497-501.
2. Clark EDB. Refolding of recombinant proteins. Curr Opin Biotechnol. 1998;9:157-163.
3. Middelberg APJ. Preparative protein refolding. Trends Biotechnol. 2002;20:437-443.
4. Baneyx F, Mujacic M. Recombinant protein folding and misfolding in Escherichia coli. Nat Biotechnol. 2004;22;1399-1408.
5. Markossian KA, Kurganov BI. Protein folding, misfolding, and aggregation: formation of inclusion bodies and aggresomes. Biochemistry. 2004;69:971-984.
6. Ordidge GC, Mannall G, Liddell J, Dalby PA, Micheletti M. A generic hierarchical screening method for the analysis of microscale refolds using an automated robotic platform. Biotechnol Prog. 2012;28;435-444.
7. Vallejo LF, Brokelmann M, Marten S, Trappe S, Cabrera-Crespo J, Hoffmann A, Gross G, Weich HA, Rinas U. Renaturation and purification of bone morphogenetic protein-2 produced as inclusion bodies in high-cell-density cultures of recombinant Escherichia coli. J Biotechnol. 2002;94:185-194.
8. Jungbauer A, Kaar W, Schlegl R. Folding and refolding of proteins in chromatographic beds. Curr Opin Biotechnol. 2004;15:487-494.
9. Schlegl R, Iberer G, Machold C, Necina R, Jungbauer A. Continuous matrix-assisted refolding of proteins. J Chromatogr A. 2003;109:119-132.
10. Razeghifard MR. On-column refolding of recombinant human interleukin-4 from inclusion inclusion bodies. Protein Expr Purif. 2004;37:180-186.
11. Suttnar J, Dyr JE, Hamšíková E, Novák J, Vonka V. Procedure for refolding and purification of recombinant proteins from Escherichia coli inclusion bodies using a strong anion exchanger. J Chromatogr B. 1994;656:123-126.
12. Batas B, Schiraldi C, Chaudhuri JB. Inclusion body purification and protein refolding using microfiltration and size exclusion chromatography. J Biotechnol. 1999;68:149-158.
13. Lanckriet H, Middelberg APJ. Continuous chromatographic protein refolding. J Chromatogr A. 2004;1022:103-113.
14. Li M, Su ZG, Janson JC. In vitro protein refoldingby chromatographic procedures. Protein Expr Purif. 2004;33:1-10.
15. Machold C, Schlegl R, Buchinger W, Jungbauer A. Matrix assisted refolding of proteins by ion exchange chromatography. J Biotech. 2005;117:83-97.
16. Freydell EJ, van der Wielen LAM, Eppink MHM, Ottens M. Techno-economic evaluation of an inclusion body solubilization and recombinant protein refolding process. Biotechnol Prog. 2011;27:1315-1328.
17. Vallejo LF, Rinas U. Strategies for the recovery of active proteins through refolding of bacterial inclusion body proteins. Microb Cell Fact. 2004;3:11.
18. Tsumoto K, Ejima D, Kumagai I, Arakawa T. Practical considerations in refolding proteins from inclusion bodies. Protein Expr Purif. 2003;28:1-8.
19. Eiberle MK, Jungbauer A. Technical refolding of proteins: do we have freedom to operate? Biotechnol J. 2010;5:547-559.
20. Clark EDB. Protein refolding for industrial processes. Curr Opin Biotechnol. 2001;12:202-207.
21. Arakawa T, Tsumoto K. The effects of arginine on refolding of aggregated proteins: not facilitate refolding, but suppress aggregation. Biochem Biophys Res Commun. 2003;304:148-152.
22. Sunitha K, Chung BH, Jang KH, Song KB, Kim CH, Rhee SK. Refolding and purification of Zymomonas mobilis levansucrase produced as inclusion bodies in fed-batch culture of recombinant Escherichia coli. Protein Expr Purif. 2000;18:388-393.
23. Anderson M, Blowers D, Hewitt N, Hedge P, Breeze A, Hampton I, Tayler I. Refolding, purification, and characterization of a loop delection mutant of human bcl-2 from bacterial inclusion bodies. Protein Expr Purif. 1999;15:162-170.
24. Willis MS, Hogan JK, Prabhakar P, Liu X, Tsai K, Wei Y, Fox T. Investigation of protein refolding using a fractional factorial screen: a study of reagent effects and interactions. Protein Sci. 2005;14:1818-1826.
25. Ho JDS, Middelberg APJ. Estimating the potential refolding yield of recombinant proteins expressed as inclusion bodies. Biotechnol Bioeng. 2004;87:584-592.
26. Boyle DM, Johnson GV, Heeren RA, Shell RE, Banerjee A, Gustafson ME. Evaluation of refolding conditions for a human recombinant fusion cytokine protein, promegapoietin-I a. Biotechnol Appl Biochem. 2008;49:73-83.
27. Jungbauer A, Kaar W. Current status of technical protein refolding. J Biotechnol. 2007;128:587-596.
28. Lee GH, Cooney D, Middelberg APJ, Choe WS. The economics of inclusion body processing. Bioprocess Biosyst Eng. 2006;29:73-90.
29. Jaenicke R. Stability and folding of domain proteins. Prog Biophys Mol Biol. 1999;71:155-241.
30. Choe WS, Nian R, Lai WB. Recent advances in biomolecular process intensification. Chem Eng Sci. 2006;61:886-906.
31. Fischer BE. Renaturation of recombinant proteins production as inclusion bodies. Biotechnol Adv. 1994;12:89-101.
32. Burgess RR. Refolding solubilized inclusion body proteins. Methods Enzymol. 2009;463:259-282.
33. Clark EDB, Schwarz E, Rudolph R. Inhibition of aggregation side reactions during in vitro protein folding. Methods Enzymol. 1999;309:217-236.
34. Ejima D, Watanabe M, Sato Y, Date M, Yamada N, Takahara Y. High yield refolding and purification process for recombinant human interleukin-6 expressed in Escherichia coli. Biotechnol Bioeng. 1999;62:301-310.
35. Ferré H, Ruffet E, Nielsen LLB, Nissen MH, Hobley TJ, Thomas ORT, Buus S. A novel system for continuous protein refolding and on-line capture by expanded bed adsorption. Protein Sci. 2005;14:2141-2153.
36. Hubbuch JJ, Thömmes J, Kula MR. Biochemical engineering aspects of expanded bed adsorption. Adv Biochem Eng Biotechnol. 2005;92:101-123.
37. Fernandez-Lahore HM, Kleef R, Kula MR, Thömmmes J. The influence of complex biological feedstock on the fluidization and bed stability in expanded bed chromatography. Biotechnol Bioeng. 1999;64:484-496.
38. Lin DQ, Kula MR, Liten A, Thömmes J. Stability of expanded beds during the application of crude feedstock. Biotechnol Bioeng. 2002;81:21-26.
39. Thömmes J, Weiher M, Karau A, Kula MR. Hydrodynamics and performance in fluidized bed adsorption. Biotechnol Bioeng. 1995;48:367-374.
40. Theodossiou I, Elsner HD, Thomas ORT, Hobley TJ. Fluidisation and dispersion behaviour of small high density pellicular expanded bed adsorbents. J Chromatogr A. 2002;964:77-89.
41. Anspach FB, Curbelo D, Hartmann R, Garke G, Deckwer WD. Expanded-bed chromatography in primary protein purification. J Chromatogr A. 1999;865:129-144.
42. Hjorth R. Expanded-bed adsorption in industrial bioprocessing: recent development. Trends Biotechnol. 1997;15:230-235.
43. Karau A, Benken C, Thömmes J, Kula MR. The influence of particle size distribution and operating conditions on the adsorption performance in fluidized beds. Biotechnol Bioeng. 1997;55:54-64.
44. Gonzále Y, Ibarra M, Gómez H, González M, Dorta L, Padilla D, Valdés R. Expanded bed adsorption processing of mammalian cell culture fluid: comparison with packed bed affinity chromatography J Chromatogr B. 2003;784:183-187.
45. Fahrner R, Blank GS, Zapata GA. Expanded bed protein A affinity chromatography of a recombinant humanized monoclonal antibody: process development, operation, and comparison with a packed bed method. J Biotechnol. 1999;75:273-280.
46. Batt B, Yabannavar VM, Singh V. Expanded bed adsorption process for protein recovery from whole mammalian cell culture broth. Bioseparation. 1995;5:41-52.
47. Johansson HJ, Jägersten C, Shiloach J. Large scale recovery and purification of periplasmic recombinant protein from E. coli using expanded bed adsorption chromatography followed by new ion exchange media. J Biotechnol. 1996;48:9-14.
48. Ng MYT, Tan WS, Abdullah N, Ling TC, Tey BT. Direct purification of recombinant hepatitis B core antigen from two different pre-conditioned unclarified Escherichia coli feedstocks via expanded bed adsorption chromatography. J Chromatogr A. 2007;1172:47-56.
49. Shepard SR, Boyd GA, Schrimsher JL. Routine manufacture of recombinant proteins using expanded bed adsorption chromatography. Bioseparation. 2001;10:51-56.
50. Cho TH, Ahn SJ, Lee EK. Refolding of protein inclusion bodies directly from E. coli homogenate using expanded bed adsorption chromatography. Bioseparation. 2002;10:189-196.
51. Goyal D, Sahoo DK, Sahni G. Hydrophobic interaction expanded bed adsorption chromatography (HI-EBAC) based facile purification of recombinant Streptokinase from E. coli inclusion bodies. J Chromatogr B. 2007:850:384-391.
52. Brobjer M. Development and scale up of a capture step (expanded bed chromatography) for a fusion protein expressed intracellularly in Escherichia coli. Bioseparation. 1999;8:219-228.
53. Chong FC, Tan WS, Biak DRA, Ling TC, Tey BT. Direct recovery of recombinant nucleocapsid protein of Nipah virus from unclarified Escherichia coli homogenate using hydrophic interaction expanded bed adsorption chromatography. J Chromatogr A. 2010;1217:1293-1297.
54. Jin T, Guan Y-X, Yao S-J, Lin D-Q, Cho M-G. On-column refolding of recombinant human interferon-γ inclusion bodies by expanded bed adsorption chromatography. Biotechnol Bioeng. 2006;49:204-216.
55. Cabanne C, Noubhani AM, Hocquellet A, Dole F, Dieryck W, Santarelli X. Purification and on-column refolding of EGFP overexpressed as inclusion bodies in Escherichia coli with expanded bed anion exchange chromatography. J Chromatogr B. 2005;818:23-27.
56. Choe WS, Clemmitt RH, Chase HA, Middelberg APJ. Coupling of chemical extraction and expanded-bed adsorption for simplified inclusion-body processing: optimization using surface plasmon resonance. Biotechnol Bioeng. 2002;81:221-232.
57. Bai Y, Glatz CE. Bioprocess considerations for expanded-bed charomatography of crude canola extract: sample preparation and adsorbent reuse. Biotechnol Bioeng. 2003;81:775-782.
58. Feuser J, Halfar M, Lütkemeyer D, Ameskamp M, Kula MR, Thömmes J. Interaction of mammalian cell culture broth with adsorbents in expanded bed adsorption of monoclonal antibodies. Process Biochem. 1999;34:159-165.
59. Ameskamp M, Priesner C, Lehmann J, Lütkemeyer D. Pilot scale recovery of monoclonal antibodies by expanded bed ion exchange adsorption. Bioseparation. 1999;8:169-188.
60. Frej A-KB. Expanded bed adsorption for recovery of renatured human recombinant interleukin 8 from Escherichia coli inclusion bodies. Bioseparation. 1996;6:265-271.
61. Arpanaei A, Heebøll-Nielsen A, Hubbuch JJ, Thomas ORT, Hobely TJ. Critical evaluation and comparison of fluid distribution systems for industrial scale expanded bed adsorption chromatography columns. J Chromatogr A. 2008;1198-1199, 131-139.
62. Lihme A, Hansen MB, Andersen IV, Burnouf T. A novel core fractionation process of human plasma by expanded bed adsorption chromatography. Anal Chem. 2010;399:102-109.
63. Chow YM, Tey BT, Ibrahim MN, Ariff A, Ling TC. Protein adsorption and hydrodynamic stability of a dense pellicular adsorbent in high-biomass expanded bed chromatography. Biotechnol Bioprocess Eng. 2006;11:268-272.
64. Xia HF, Lin DQ, Yao SJ. Evaluation of new high-density ion exchange adsorbents for expanded bed adsorption chromatography. J Chromatogr A. 2007;1145:58-66.
65. Zhao J, Lin DQ, Wang YC, Yao SJ. A novel beta-cyclodextrin polyer/tungsten carbide composite matrix for expanded bed adsorption: preparation and characterization of physical properties. Carbohydr Polym. 2010;80:1085-1090.
66. Wrzosek K, Gramblička M, Tóthová D, Antošová M, Polakovič M. Impact of ionic strength on adsorption capacity of chromatographic particles employed in separation of monoclonal antibodies. Chem Pap. 2010;64;461-468.
67. Chang YK, Chase HA. Development of operating conditions for protein purification using expanded bed techniques: the effect of the degree of bed expansion on adsorption performance. Biotechnol Bioeng. 1996;49:512-526.
68. Dave P, Dizon-Maspat J, Cano T. Evaluation and implementation of a single-stage multimedia harvest depth filter for a large-scale antibody process. BioProcess Int. 2009;7:8-17.
69. Russell E, Wang A, Rathore AS. Harvest of a therapeutic protein product from high cell density fermentation broths: principles and case study. In: Shukla AA, Etzel MR, Gadam S, Editors. Process Scale Bioseparations for the Biopharmaceutical Industry. Boca Raton: CRC Press; 2007.
70. Badmington F, Payne M, Wilkins R, Honig E. Vmax testing for practical microfiltration train scale-up in biopharmaceutical processing. Pharma Technol. 1995;19:64-76.
71. Kandula S, Babu S, Jin M, Shukla AA. Design of a filter train for precipitate removal in monoclonal antibody downstream processing. Biotechnol Appl Biochem. 2009;54:149-155.
72. Rajniak P, Tsinontides SC, Pham D, Hunke WA, Reynolds SD, Chern RT. Sterilizing filtration-principles and practice for successful scale-up to manufacturing. J Membr Sci. 2008;325:223-237.
73. Carter WAHR. (5451 Randolph Rd., Rockville, MD 20852), Silver, Gerald (HEM Research) Stabilization and purification of interferon with propylene glycol, resulting in a non-toxic product. 1984.
74. Gekko K, Koga S. The stability of protein structure in aqueous propylene glycol: amino acid solubility and preferential solvation of protein. Biochim Biophys Acta Protein Struct Mol Enzymol. 1984;786:151-160.
75. Yamamoto S, Akazaki N, Kaltenbrunner O, Watler P. Factors affecting dispersion in expanded bed chromatography. Bioseparation. 1999;8:33-41.
76. Belew M, Zhou Y, Wang S, Nyström LE, Janson JC. Purification of recombinant human granulocyte-macrophage colony-stimulating factor from the inclusion bodies produced by transformed Escherichia coli cells. J Chromatogr B. 1994;679:67-83.
77. Ghose S, Chase H. Expanded bed chromatography of proteins in small diameter columns. I. Scale down and validation. Bioseparation. 2000;9:21-28.
78. Ghose S, Chase H. Expanded bed chromatography of proteins in small diameter columns. II. Methods development and scale up. Bioseparation. 2000;9:29-36.
79. Willoughby N, Martin P, Titchener-Hooker N. Extreme scale-down of expanded bed adsorption: purification of an antibody fragment directly from recombinant E. coli culture. Biotechnol Bioeng. 2004;87:641-647.