Purification of Antibodies From Transgenic Plants

Process Scale Purification of Antibodies

Volumn , Issue , 2008, Pages 387-406

  Nikolov, Zivko L ^a   Regan, Jeffrey T ^b   Dickey, Lynn F ^c   Woodard, Susan L ^d  

^a Texas A and M University   (United States)

^b Biolex Therapeutics   (United States)

^c VP of Research and Technology Development   (United States)

^d TEXAS A AND M UNIVERSITY   (United States)

Author keywords

Downstream processing of antibodies produced; Polishing steps; Purification of antibodies from transgenic plants

Indexed keywords

EID: 84890759470     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470444894.ch19     Document Type: Chapter

References (76)

1. Nikolov, Z.L., Woodard, S.L. (2004). Downstream processing of recombinant proteins from transgenic feedstock. Current Opinion in Biotechnology 15, 479-86
2. Ma, J.K.-C., Drake, P.M.W., Christou, P. (2003). The production of recombinant pharmaceutical proteins in plants. Nature Reviews Genetics 4, 794-805
3. Schillberg, S., Twyman, R.M., Fischer, R. (2005). Opportunities for recombinant antigen and antibody expression in transgenic plants-Technology assessment . Vaccine 23,1764-1769
4. Evangelista, R.L., Kusnadi, A.R., Howard, J.A., Nikolov, Z.L. (1998). Process and economic evaluation of the extraction and purification of recombinant β-glucuroni- dase from transgenic corn. Biotechnology Progress 14, 607-614
5. Mison, D., Curling, J. (2000).The industrial production costs of recombinant therapeutic proteins expressed in corn. BioPharm International 13, 48-54
6. Watler, P.K. (2002). Process design and economics for large -scale monoclonal anti-body manufacturing. Presentation at the 8th IBC International Conference, San Diego, CA, 2002
7. Hiatt, A., Cafferkey, R., Bowdish, K. (1989). Production of antibodies in transgenic plants. Nature 342,76-78
8. Nechansky, A., Schuster, M., Jost, W., Siegl, P., Wiederkum, S., Gorr, G., Kircheis, R. (2007). Compensation of endogenous IgG mediated inhibition of antibody -dependent cellular cytotoxicity by glyco -engineering of therapeutic antibodies. Molecular Immunology 44,1815-1817
9. Bardor, M., Loutelier -Bourhis, C., Paccalet, T., Cosette, P., Fitchette, A.C., Vézina, L.P., Trépanier, S., Dargis, M., Lemieux, R., Lange, C., Faye, L., Lerouge, P. (2003). Monoclonal C5 -1 antibody produced in transgenic alfalfa plants exhibits a N-gly- cosylation that is homogenous and suitable for glyco -engineering into human -compatible structures. Plant Biotechnology Journal 1,451-62
10. Zeitlin, L., Olmsted, S.S., Moench, T.R., Co, M.S., Martinell, B.J., Paradkar, V.M., Russell, D.R., Queen, C., Cone, R.A., Whaley, K.J. (1998). A humanized monoclonal antibody produced in transgenic plants for immunoprotection of the vagina against genital herpes. Nature Biotechnology 16,1361-1364
11. Negrouk, V., Eisner, G., Lee, H., Han, K., Taylor, D., Wong, H. (2005). Highly efficient transient expression of functional recombinant antibodies in lettuce. Plant Science 169,433-38
12. Stöger, E., Vaquero, C., Torres, E., Sack, M., Nicholson, L., Drossard, J., Williams, S., Keen, D., Perrin, Y., Christou, P., Fischer, R. (2000). Cereal crops as viable production and storage systems for pharmaceutical scFv antibodies. Plant Molecular Biology 42, 583-590
13. Alamillo, J.M., Monger, W., Sola, I., García, B., Perrin, Y., Bestagno, M., Burrone, O.R., Sabella, P., Plana-Durán, J., Enjuanes, L., Lomonossoff, G.P., García, J.A. (2006). Use of virus vectors for the expression in plants of active full -length and single chain anti -coronavirus antibodies. Biotechnology Journal 1,1103-1111
14. Law, R.D., Russell, D.A.,Thompson, L.C., Schroeder, S.C., Middle, C.M., Tremaine, M.T., Jury, T.P., Delannay, X., Slater, S.C. (2006). Biochemical limitations to high - level expression of humanized monoclonal antibodies in transgenic maize seed endosperm. Biochim Biophys Acta 1760,1434-44
15. Mayfield, S.P., Franklin, S.E., Lerner, R.A. (2003). Expression and assembly of a fully active antibody in algae. Proceedings of the National Academy of Sciences of the United States of America 100, 438-42
16. Gasdaska, J.R., Spencer, D., Dickey, L. (2003). Advantages of therapeutic protein production in aquatic plant Lemna. Bioprocessing Journal 2,49-56
17. Fielder, U., Conrad, U. (1995). High-level production and long -term storage of engineered antibodies in transgenic tobacco seeds. Bio/technology (N Y) 13, 1090-1093
18. Fischer, R., Schumann, D., Zimmermann, S., Drossard, J., Sack, M., Schillberg, S. (1999). Expression and characterization of bispecific single-chain Fv fragments produced in transgenic plants. European Journal of Biochemistry 262, 810-816
19. Perrin, Y., Vaquero, C., Gerrard, I., Sack, M., Drossard, J., Stoger, E., Christou, P., Fischer, R. (2000).Transgenic pea seeds as bioreactors for the production of a single chain Fv fragment (scFV) antibody used in cancer diagnosis and therapy. Molecular Breeding 6, 345-352
20. Van Droogenbroeck, B., Cao, J., Stadlmann, J., Altmann, F., Colanesi, S., Hillmer, S., Robinson, D.G., Van Lerberge, E., Terryn, N., Van Montagu, M., Liang, M., Depicker, A., De Jaeger, G. (2007). Aberrant localization and underglycosylation of highly accumulating single -chain Fv-Fc antibodies in transgenic Arabidopsis seeds. Proceedings of the National Academy of Sciences of the United States of America 104, 1430-1435
21. De Neve, M., De Loose, M., Jacobs, A., Van Houdt, H., Kaluza, B., Weidle, U., Van Montagu, M., Depicker, A. (1993). Assembly of an antibody and its derived anti-body fragment in Nicotiana and Arabidopsis. Transgenic Research 2, 227-237
22. Ma, J.K., Drake, P.M., Chargelegue, D., Obregon, P. and Prada, A. (2005). Antibody processing and engineering in plants, and new strategies for vaccine production. Vaccine 23,1814-1818
23. Hood, E.E., Woodard, S.L., Horn, M.E. (2002). Monoclonal antibody manufacturing in transgenic plants Myths and realities. Current Opinion in Biotechnology 13, 630-635
24. Ma, J.K.-C., Hiatt, A., Hein, M., Vine, N.D., Wang, F., Stabila, P., van Dolleweerd, C. Mostov, K., Lehner, T. (1995). Generation and assembly of secretory antibodies in plants. Science 268,716-719
25. Gorr, G., Jost, W. (2005). Glycosylation design in transgenic moss for better product efficiency. Bioprocessing Journal 4, 26-30
26. Khoudi, H., Laberge, S.,Ferullo, J.M., Bazin, R., Darveau,A., Castonguay,Y., Allard, G., Lemieux, R., Vezina, L.P. (1999). Production of a diagnostic monoclonal anti-body in perennial alfalfa plants. Biotechnology and Bioengineering 64,135-143
27. Cox, K.M., Sterling,J.D., Regan, J.T., Gasdaska, J.R.,Frantz, K.K., Peele, C.G., Black, A., Passmore, D., Moldovan-Loomis, C., Srinivasan, M., Cuison, S., Cardarelli, P.M., Dickey, L.F. (2006). Glycan optimization of a human monoclonal antibody in the aquatic plant Lemna minor. Nature Biotechnology 24,1591-1597
28. McCormick, A.A., Kumagai, M.H., Hanley, K., Turpen, T.H., Hakim, I., Grill, L.K., Tusé, D., Levy, S., Levy, R. (1999). Rapid production of specific vaccines for lym- phoma by expression of the tumor-derived single -chain Fv epitopes in tobacco plants. Proceedings of the National Academy of Sciences of the United States of America 96,703-708
29. Peeters, K., De Wilde, C., Depicker, A. (2001). Highly efficient targeting and accumulation of a F(ab) fragment within the secretory pathway and apoplast of Arabi- dopsis thaliana. European Journal of Biochemistry 268, 4251-260
30. Gomord, V., Chamberlain, P., Jefferis, R., Faye, L. (2005). Biopharmaceutical production in plants: Problems, solutions and opportunities. Trends in Biotechnology 23, 559-565
31. Schuster, M., Jost, W., Mudde, G.C., Wiederkum, S., Schwager, C., Janzek, E., Altmann, F., Stadlmann, I, Stemmer, C., Gorr, G. (2007). In vivo glyco-engineered antibody with improved lytic potential produced by an innovative non -mammalian expression system. Biotechnology Journal 2, 700-708
32. Bakker, H., Rouwendal, G.J.A., Karnoup, A.S., Florack, D.E.A., Stoopen, G.M., Helsper, J.P.F.G., van Ree, R., van Die, I., Bosch, D. (2006). An antibody produced in tobacco expressing a hybrid β-1,4 galactosyltransferase is essentially devoid of plant carbohydrate epitopes. Proceedings of the National Academy of Sciences of the United States of America 103,7577-7582
33. Daniell, H., Carmona-Sanchez, O., Burns, B. (2004). Chloroplast derived antibodies, biopharmaceuticals and edible vaccines. In Fisher, R., Schillberg, S. (eds.) Molecular Farming, Wiley-VCH, Weinheim, pp. 113-133
34. Nuttall, I, Ma, J.K.-C., Frigerio, L. (2005). A functional antibody lacking N-linked glycans is efficiently folded, assembled and secreted by tobacco mesophyll protoplasts. Plant Biotechnology Journal 3, 497-504
35. Raju, T.S., Scallon, B.J. (2006). Glycosylation in the Fc domain of IgG increases resistance to proteolytic cleavage by papain. Biochemical and Biophysical Research Communications 341, 797-803
36. Raju, T.S., Scallon, B. (2007). Fc glycans terminated with N -acetylglucosamine residues increase antibody resistance to papain. Biotechnology Progress 23, 964-971
37. Stevens, L.H., Stoopen, G.M., Elbers I.J., Molthoff, J.W., Bakker, H.A., Lommen A, Bosch D, Jordi W. (2000). Effect of climate conditions and plant developmental stage on the stability of antibodies expressed in transgenic tobacco. Plant Physiology 124,173-182
38. Ma, J.K.-C, Hikmat, B.Y.,Wycoff, K.,Vine, N.D., Chargelegue, D.,Yu, L., Hein, M.B., Lehner, T. (1998). Characterization of a recombinant plant monoclonal secretory antibody and preventative immunotherapy in humans. Nature Medicine 4, 601-606
39. Wongsamuth, R., Doran, P.M. (1997). Production of monoclonal antibodies by tobacco hairy roots. Biotechnology and Bioengineering 54,401-15
40. Sharp, J.M., Doran, P.M. (2001). Characterization of monoclonal antibody fragments produced by plant cells. Biotechnology and Bioengineering 73, 338-346
41. Nikolov, Z.L., Hammes, D. (2002). Production of recombinant proteins from trans- genic crops. In Hood, E.E., Howard, J.A. (eds.) Plants as Factories for Protein Production, Kluwer Academic Publishers, Dordrecht, pp. 159-174
42. Moloney, M.M. (1995). Molecular farming in plants: Achievements and prospects. Biotechnology and Biotechnological Equipment 9, 3-9
43. Bratcher, B., Garger, S.J., Holtz, R.B., McCulloch, M.J. (2005). Flexible processing apparatus for isolating and purifying viruses, soluble proteins, and peptides from plant sources. US Patent #6906172
44. D'Aoust, M-A., Lerouge P., Busse U., Bilodeau P., Trepanier S., Faye, L., Vezina L.-P. (2004). Efficient and reliable production of pharmaceuticals in alfalfa. In Fisher, R., Schillberg, S. (eds.) Molecular Farming, Wiley-VCH, Weinheim, pp. 1-12
45. Nandi, S., Yalda, E., Lu. S., Nikolov, Z.L., Misaki, R., Kazuhito,F., Huang, N. (2005). Process development and economic evaluation of recombinant human lactoferrin expressed in rice grain. Transgenic Research 14, 237-249
46. Bai, Y. Nikolov, Z.L., Glatz, C.E. (2002). Aqueous extraction of ß-glucuronidase from transgenic canola: kinetics and microstructure. Biotechnology Progress 18, 1301-1305
47. Turpen, T.T., Garger, S.J., McCulloch, M.J., Cameron, T.I., Samonek-Potter, M. L., Holtz, R.B. (2001). Method for recovering proteins from the interstitial fl uid of plant tissues. US Patent #6284875
48. Fischer, R., Liao, Y.-C., Drossard, I (1999). Affinity purification of a TMV -specific recombinant full -size antibody from transgenic tobacco cell culture suspension. Journal of Immunological Methods 226,1-10
49. Valdes, R., Gomez, L., Padilla, S., Brito, I, Reyes, B., Alvarez, T., Mendoza, O., Herrera, O., Ferro, W., Pujol, M., Leal, V., Linares, M., Hevia, Y., Garcia, C., Mila, L., Garcia, O., Sanchez, R., Acosta, A., Geada, D., Paez, R., Luis Vega, J., Borroto, C. (2003). Large-scale purification of an antibody directed against hepatitis B surface antigen from transgenic tobacco. Biochemical and Biophysical Research Communications 341, 94-100
50. Pujol, M., Ramirez, N.I., Ayala, M., Gavilondo, J.V., Valdes, R., Rodriguez, M., Brito, I, Padilla, S., Gomez, L., Reyes, B., Peral, R., Perez, M., Marcelo, J.L., Mila, L., Sanchez, R.F., Paez, R., Cremata, J.A., Enriquez, G., Mendoza, O., Ortega, M., Borroto, C. (2005). An integral approach towards a practical application for a plant- made monoclonal antibody in vaccine purification. Vaccine 23,1833-1837
51. Bai, Y., Glatz, C.E. (2003). Bioprocess considerations for expanded -bed chromatog- raphy of crude canola extract: Sample preparation and adsorbent reuse. Biotechnology and Bioengineering 81,775-782
52. Menkhaus, T.J., Glatz, C.E. (2004). Compatibility of column inlet and adsorbent designs for processing of corn endosperm extracts by expanded bed adsorption . Biotechnology and Bioengineering 87, 324-336
53. Menkhaus,T.J., Glatz, C.E. (2005). Antibody capture from corn endosperm extracts by packed bed and expanded -bed adsorption. Biotechnology Progress 21, 473-85
54. Stoger, E., Sack, M., Perrin, Y., Vaquero, C., Torres, E., Twyman, R.M., Christou, P., Fischer, R. (2002). Practical considerations for pharmaceutical antibody production in different crop systems. Molecular Breeding 9,149-158
55. Wilken, L.R., Nikolov, Z. (2006). Factors infl uencing recombinant human lysozyme extraction and cation exchange adsorption. Biotechnology Progress 23,745-752
56. Platis, D., Labrou, N.E. (2006). Development of an aqueous two -phase partitioning system for fractionating therapeutic proteins from tobacco extract. Journal of Chromatography A 1128,114-124
57. Miele, L. (1997). Plants as bioreactors for biopharmaceuticals: Regulatory considerations. Trends in Biotechnology 15,45-50
58. Komarnytsky, S., Borisjuk, N., Yakoby, N., Garvey, A., Raskin, I. (2006). Cosecretion of protease inhibitor stabilizes antibodies produced by plant roots. Plant Physiology 141,1186-1193
59. Rivard, D., Anguenot, R., Brunelle, F., Le, V.Q., Vézina, L.P., Trépanier, S., Michaud, D. (2006). An in -built proteinase inhibitor system for the protection of recombinant proteins recovered from transgenic plants. Plant Biotechnology Journal 4, 359-368
60. Ghose, S., Allen, M., Hubbard, B., Brooks, C., Cramer, S.M. (2005). Antibody variable region interactions with Protein A: Implications for the development of generic purification processes. Biotechnology and Bioengineering 92, 665-673
61. Akerstrom, A., Nilson Bo, H.K., Hoogenboom, H.R., Bjorck, L. (1994). On the interaction between single chain Fv antibodies and bacterial immunoglobulin- binding proteins. Journal of Immunological Methods 177, 151-163
62. Inganas, M. (1981). Comparison of mechanisms of interaction between protein A from Staphylococcus aureus and human monoclonal IgG, IgA and IgM in relation to the classical Fc gamma and the alternative F(ab0)2 protein A interactions. Scan dinavian Journal of Immunology 13, 343-352
63. Starovasnik, M.A., O'Connell, M.P.,Fairbrother,W.J., Kelley, R.F. (1999). Antibody variable region binding by staphylococcal Protein A: Thermodynamic analysis and location of the Fv binding site on E -domain. Protein Science 8,1423-1431
64. Vidal, M.A., Conde, F.P. (1985). Alternative mechanism of Protein A immunoglobu- lin interaction: The VH associated reactivity of a monoclonal human IgM. Journal of Immunology 135,1232-1238
65. Sommerfield, S., Strube, J. (2005). Challenges in biotechnology productionGeneric processes and process optimization for monoclonal antibodies. Chemical Engineering and Processing 44, 1123-1137
66. Todorova-Balvay, D., Pitiot, O., Bourhim, M., Srikrishnan, T., Vijayalakshmi, M. (2004). Immobilized metal -ion affinity chromatography of human antibodies and their proteolytic fragments. Journal of Chromatography B 808, 57-62
67. Guerrier, L., Girot, P., Schwartz, W., Boschetti, E. (2000). New method for the selective capture of antibodies under physiological conditions. Bioseparation 9, 211-221
68. Schwartz, W., Judd, D., Wysocki, M., Guerrier, L., Birck-Wilson, E., Boschetti, E. (2001). Comparison of hydrophobic charge induction chromatography with affinitychromatography on protein A for harvest and purification of antibodies. Journal of Chromatography A 908, 251-263
69. Ghose, S., Hubbard, B., Cramer, S.M. (2006). Evaluation and comparison of alternatives to Protein A chromatography mimetic and hydrophobic charge induction chromatographic stationary phases. Journal of Chromatography A 1122,144-152
70. Bjorck, L., Akerstrom, B. (1990). Protein L: a peptococcal cell wall protein with affinity for immunoglobulin light chains. In Boyle, M.D.P (ed.) Bacterial Immuno- globulin Binding Proteins, Vol. 1, Academic Press, San Diego, CA, pp. 267-278
71. Nilsson, B.H.K, Solomon, A., Bjorck, L., Akerstrom, B. (1992). Protein L from Peptostreptococcus magnus binds to the κ light chain variable domain. Journal of Biological Chemistry 267, 2234-2239
72. Low, D., O'Leary, R., Pujar, N.S. (2007). Future of antibody purification. Journal of Chromatography B 848, 48-63
73. Terman, D.S., Bertram, J.H. (1985). Antitumor effects of immobilized protein A and staphylococcal products: linkage between toxicity and efficacy, and identification of potential tumoricidal reagents. European Journal of Cancer and Clinical Oncology 21,1115-1122
74. Gagnon, P. (1996). Purification Tools for Monoclonal Antibodies. Validated Biosys- tems, USA
75. Chen, J., Tetrault, J., Ley, A. (2008). Comparison of standard and new generation hydrophobic interaction chromatography resins in the monoclonal antibody purification process. Journal of Chromatography A 1177, 272-281
76. Tugcu, N., Roush, D.J., Göklen, K.E. (2008). Maximizing productivity of chromatography steps for purification of monoclonal antibodies. Biotechnology and Bio- engineering 99, 599-613