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Monoklonal Antikor Üretimleri İçin Alt Akım Prosesleri

Year 2021, Volume: 4 Issue: 1, 85 - 96, 29.04.2021

Emre Burak Erkal , Dilara Baş Melisa Köprülü Melis Korkmaz Deniz Demirhan Özge Can

Abstract

Son yıllarda, terapötik monoklonal antikorların (mAb'lar) geliştirilmesi büyük önem kazanmıştır ve bu moleküller dünya biyoteknolojik ilaç pazarında giderek daha önemli bir hale gelmiştir. Birçok biyotekno-loji şirketi monoklonal antikor üretimine yatırım yapmaktadır. Bu moleküllerin üretimi için kullanılan mevcut saflaştırma yöntemleri bu derlemede tartışılmaktadır. Hücre hasadı, Protein A afinite kroma-tografisi ve ileri saflaştırma adımları gibi monoklonal antikorlar için temel geri kazanım ve saflaştırma işlemleri özetlenmiştir.

Keywords

Biyoteknoloji Monoklonal Antikorlar; Alt Akım Proses

References

  • A.A. Shukla, P. Hinckley, P. Gupta, Y. Yigzaw, B. Hubbard, Bioproc. Int. 3 (5) (2005) 36
  • Ansaldi DA, Lester P. Separation of polypeptide monomers. United States Patent No: US 6620918 2003
  • Aruffo, in: S. Chamow, A. Ashkenazi (Eds.), Anti-body Fusion Proteins, Wiley-Liss, New York, 1999, p. 221.
  • Birch JR, Racher JR. Antibody production. Adv Drug Delivery Rev 2006; 58:671-85.
  • C.S. Parnham, R.H. Davis, Biotechnol. Bioeng. 47 (1995) 155.
  • Curtis S, Lee K, Blank GS, Brorson K, Xu Y. Gene-ric/ matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mo-de. Biotechnol Bioeng 2003; 84:179-86.
  • Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerhelm D, Vanderlaan M, et al. Industrial puri-fication of pharmaceutical antibodies: develop-ment, operation and validation of chromatog-raphy processes. Biotechnol Genet Eng Rev 2001; 18:301-27.
  • Fahrner RL, Whitney DH, Vanderlaan M, Blank GS. Performance comparison of protein A affi-nitychromatography sorbents for purifying re-combinant monoclonal antibodies. Biotechnol Appl BioChem 1999; 30:121-8.
  • Fahrner, H.L. Knudsen, C.D. Basey, W. Galan, D. Feuerhelm, M. Vanderlaan, G.S. Blank, Biotech-nol. Gen. Eng. Rev. 18 (2001) 301.
  • FDA Q5A Guidance Document: Viral Safety Evalu-ation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Federal Register, vol. 63(185), 1998, p. 51074. Available at http://www.fda.gov/cder/guidance/Q5A-fnl.PDF.
  • Follman D, Fahrner R. Factorial screening of anti-body purification process using three chroma-tography steps without protein A. J Chromatogr A 2004; 1024: 79-85
  • G. Blank, Recovery of Biological Products X Con-ference, Cancun, Mexico, June, 2001. Keller, T. Friedmann, A. Boxman, Trends Biotechnol. 19 (11) (2001) 438.
  • G. Kronvall, et al., J. Immunol. 111 (1973) 141.
  • G. Sofer, Biopharm. Int. 16 (1) (2003) 50.
  • Gagnon P, Ng P, Zhen J, Aberin C, He J, Mekosh H, et al. A ceramic hydroxyapatite based purifica-tion platform. BioProcess Int 2006; 4:50-60.
  • Gerngross TU. Advances in the production of human therapeutic proteins in yeasts and fila-mentous fungi. Nat Biotechnol 2004; 11:1409-12.
  • Ghose S, Hubbard B, Cramer SM. Binding capa-city differences for antibodies and Fc-fusion pro-teins on protein A chromatographic materials. Biotechnol Bioeng 2007; 96:768-79.
  • Guse A, Milton A, Schulze-Koops H, Muller B, Roth E, Simmer B. Purification and analytical characte-rization of an anti-CD4 monoclonal antibody for human therapy. J Chromatogr A 1994; 661:13-23.
  • H. Hjelm, K. Hjelm, J. Sjoquist, FEBS Lett. 28 (1972) 73.
  • Halan, V., Maity, S., Bhambure, R., & Rathore, A. S. (2018). Multimodal chromatography for purifi-cation of biotherapeutics – a review. Current Protein & Peptide Science, 20(1), 4-13. doi:10.2174/1389203718666171020103559
  • Harinarayan C, Mueller J, Ljunglof A, Fahrner R, Van Alstine J, van Reis R. An exclusion mecha-nism in ion exchange chromatography. Biotech-nol Bioeng 2006; 95:775-87.
  • Hellwig S, Drossard J, Twyman RM, Fischer R. Plant cell cultures for the production of recombi-nant proteins. Nat Biotechnol 2004; 11:1415-22.
  • J.P. Maybury, M. Hoare, P. Dunnill, Biotechnol. Bioeng. 67 (2000) 265.
  • J.V. Fiore, W.P. Olson, S.L. Holst, in: J. Curling (Ed.), Methods of Plasma Protein Fractionation, Academic Press, New York, 1980, p. 239.
  • K. Brorson, S. Krejci, K. Lee, E. Hamilton, K. Stein, Y. Xu, Biotechnol. Bioeng. 82 (2003) 321
  • Kallberg, K., Johansson, H., & Bulow, L. (2012). Multimodal chromatography: An efficient tool in downstream processing of proteins. Biotechno-logy Journal, 7(12), 1485-1495. doi:10.1002/biot.201200074
  • Kato Y, Nakamura K, Kitamura T, Hasegawa M, Sasaki H. Hydrophobic interaction chromatog-raphy at low salt concentration for the capture of monoclonal antibodies. J Chromatogr A 2004; 1036:45-50.
  • Kempken R, Pressman A, Berthold W. Assess-ment of a disc stack centrifuge for use in mam-malian cell separation. Biotechnol Bioeng 1995; 46:132-8
  • KP. Gagnon, Purification Tools for Monoclonal Antibodies, Validated Biosystems, Tucson, AZ, 1995.
  • L.S. Hanna, P. Pine, G. Reuzinsky, S. Nigam, D.R. Omstead, Biopharm. Int. (October) (1991) 33. R.L.
  • Liu, Hui F., et al. "Recovery and purification pro-cess development for monoclonal antibody pro-duction." MAbs. Vol. 2. No. 5. Taylor & Francis, 2010.
  • Low D, O’Leary R, Pujar NS. Future of antibody purification. J Chromatogr B 2007; 848:48-63.
  • Luo R, Waghmare R, Krishnan M, Adams C, Poon E, Kahn D. High-concentration UF/DF of a monoc-lonal antibody. Bioprocess Int 2006; 4:44-6.
  • M.A. van Dijk, J.G.J. van de Winkel, Curr. Opin. Chem. Biol. 5 (4) (2001) 368.
  • Manzke O, Tesch H, Diehl V, Bohlen H. Single-step purification of bispecific monoclonal antibo-dies for immunotherapeutic use by hydrophobic interaction chromatography. J Immunol Methods 1997; 208: 65-73.
  • Mhatre R, Nashabeh W, Schmalzing D, Yao X, Fuchs M, Whitney D, et al. Purification of antibody Fab fragments by cation-exchange chromatog-raphy and pH gradient elution. J Chromatogr A 1995; 707:225-31.
  • Nikolov ZL, Woodard SL. Downstream processing of recombinant proteins from transgenic feeds-tock. Curr Opin Biotechnol 2004; 15:479-86
  • Norling LA, Lute S, Emery R, Khuu W, Voisard M, Xu Y, et al. Impact of multi re-use of anion exchange chromatography media on virus re-moval. J Chromatogr A 2005; 1069:79-89.
  • P. Gagnon, Purification Tools for Monoclonal An-tibodies, Validated Biosystems, Tucson, AZ, 1995.
  • Porath J. Salt-promoted adsorption: recent deve-lopments. J Chromatog 1986; 376:331-41
  • R. Hahn, K. Shimahara, F. Steindl, A. Jungbauer, J. Chromatogr. A 1102 (2006) 224.
  • Reichert JM, Valge-Archer VE. Development trends for monoclonal antibody cancer therapeu-tics. Nat Rev Drug Discov 2007; 6:349-56
  • Rinderknecht E, Zapata G. Antibody purification. United States Patent Application 2002/0002271 2002.
  • S. Curtis, K. Lee, G. Blank, Y. Xu, Biotechnol. Bio-eng. 84 (2) (2003) 179.
  • S. Ghose, M. Allen, B. Hubbard, C. Brooks, S.M. Cramer, Biotechnol. Bioeng. 92 (2005) 665.
  • Shpritzer R. Evaluation of a continuous disk stack centrifuge for the clarification of mammalian cell cultures. 225th ACS National Meeting, New Orle-ans, LA 2003.
  • Shukla, Abhinav A., et al. "Downstream proces-sing of monoclonal antibodies—application of platform approaches." Journal of Chromatog-raphy B 848.1 (2007): 28-39.
  • T. Arakawa, J. Philo, K. Tsumoto, R. Yumioka, D. Ejima, Protein Express. Purif. 36 (2004) 244.
  • T. Ireland, H. Lutz, M. Siwak, G. Bolton, Biopharm. Int. 11 (2004) 38.
  • Tutunjian RS. Ultrafiltration processes in biotech-nology, in Principles of Biotechnology: Enginee-ring Considerations. Cooney CL, Humphrey AE, Editors. Pergamon Press: Elmsford, New York 1985; 411-37.
  • vanReis R, Zydney AL. Protein ultrafiltration. in Encyclopedia of Bioprocess Technology-Fermentation, Biocatalysis and Bioseparation. Flickinger MC, Drew SW, Editors. John Wiley & Sons 1999; 2197-214.
  • Wan M. Process mapping-A necessary prelude for process changing. IBC’s BioProcess Internati-onal Conference 2004; Boston MA.
  • Y. Yigzaw, R. Piper, M. Tran, A.A. Shukla, Biotech-nol. Prog. 22 (2006) 288
  • Y. Yigzaw, R. Piper, M. Tran, A.A. Shukla, Biotech-nol. Prog. 22 (2006) 288.
  • Zettlitz, K. A. (2010). Protein a/g chromatog-raphy. Antibody Engineering, 531-535. doi:10.1007/978-3-642-01144-3_34
  • Zhou JX. Development of future downstream process for commercial monoclonal antibody production. Presentation at Asia bioLogic 2007; Beijing, China

Year 2021, Volume: 4 Issue: 1, 85 - 96, 29.04.2021

Emre Burak Erkal , Dilara Baş Melisa Köprülü Melis Korkmaz Deniz Demirhan Özge Can

Abstract

References

  • A.A. Shukla, P. Hinckley, P. Gupta, Y. Yigzaw, B. Hubbard, Bioproc. Int. 3 (5) (2005) 36
  • Ansaldi DA, Lester P. Separation of polypeptide monomers. United States Patent No: US 6620918 2003
  • Aruffo, in: S. Chamow, A. Ashkenazi (Eds.), Anti-body Fusion Proteins, Wiley-Liss, New York, 1999, p. 221.
  • Birch JR, Racher JR. Antibody production. Adv Drug Delivery Rev 2006; 58:671-85.
  • C.S. Parnham, R.H. Davis, Biotechnol. Bioeng. 47 (1995) 155.
  • Curtis S, Lee K, Blank GS, Brorson K, Xu Y. Gene-ric/ matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mo-de. Biotechnol Bioeng 2003; 84:179-86.
  • Fahrner RL, Knudsen HL, Basey CD, Galan W, Feuerhelm D, Vanderlaan M, et al. Industrial puri-fication of pharmaceutical antibodies: develop-ment, operation and validation of chromatog-raphy processes. Biotechnol Genet Eng Rev 2001; 18:301-27.
  • Fahrner RL, Whitney DH, Vanderlaan M, Blank GS. Performance comparison of protein A affi-nitychromatography sorbents for purifying re-combinant monoclonal antibodies. Biotechnol Appl BioChem 1999; 30:121-8.
  • Fahrner, H.L. Knudsen, C.D. Basey, W. Galan, D. Feuerhelm, M. Vanderlaan, G.S. Blank, Biotech-nol. Gen. Eng. Rev. 18 (2001) 301.
  • FDA Q5A Guidance Document: Viral Safety Evalu-ation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Federal Register, vol. 63(185), 1998, p. 51074. Available at http://www.fda.gov/cder/guidance/Q5A-fnl.PDF.
  • Follman D, Fahrner R. Factorial screening of anti-body purification process using three chroma-tography steps without protein A. J Chromatogr A 2004; 1024: 79-85
  • G. Blank, Recovery of Biological Products X Con-ference, Cancun, Mexico, June, 2001. Keller, T. Friedmann, A. Boxman, Trends Biotechnol. 19 (11) (2001) 438.
  • G. Kronvall, et al., J. Immunol. 111 (1973) 141.
  • G. Sofer, Biopharm. Int. 16 (1) (2003) 50.
  • Gagnon P, Ng P, Zhen J, Aberin C, He J, Mekosh H, et al. A ceramic hydroxyapatite based purifica-tion platform. BioProcess Int 2006; 4:50-60.
  • Gerngross TU. Advances in the production of human therapeutic proteins in yeasts and fila-mentous fungi. Nat Biotechnol 2004; 11:1409-12.
  • Ghose S, Hubbard B, Cramer SM. Binding capa-city differences for antibodies and Fc-fusion pro-teins on protein A chromatographic materials. Biotechnol Bioeng 2007; 96:768-79.
  • Guse A, Milton A, Schulze-Koops H, Muller B, Roth E, Simmer B. Purification and analytical characte-rization of an anti-CD4 monoclonal antibody for human therapy. J Chromatogr A 1994; 661:13-23.
  • H. Hjelm, K. Hjelm, J. Sjoquist, FEBS Lett. 28 (1972) 73.
  • Halan, V., Maity, S., Bhambure, R., & Rathore, A. S. (2018). Multimodal chromatography for purifi-cation of biotherapeutics – a review. Current Protein & Peptide Science, 20(1), 4-13. doi:10.2174/1389203718666171020103559
  • Harinarayan C, Mueller J, Ljunglof A, Fahrner R, Van Alstine J, van Reis R. An exclusion mecha-nism in ion exchange chromatography. Biotech-nol Bioeng 2006; 95:775-87.
  • Hellwig S, Drossard J, Twyman RM, Fischer R. Plant cell cultures for the production of recombi-nant proteins. Nat Biotechnol 2004; 11:1415-22.
  • J.P. Maybury, M. Hoare, P. Dunnill, Biotechnol. Bioeng. 67 (2000) 265.
  • J.V. Fiore, W.P. Olson, S.L. Holst, in: J. Curling (Ed.), Methods of Plasma Protein Fractionation, Academic Press, New York, 1980, p. 239.
  • K. Brorson, S. Krejci, K. Lee, E. Hamilton, K. Stein, Y. Xu, Biotechnol. Bioeng. 82 (2003) 321
  • Kallberg, K., Johansson, H., & Bulow, L. (2012). Multimodal chromatography: An efficient tool in downstream processing of proteins. Biotechno-logy Journal, 7(12), 1485-1495. doi:10.1002/biot.201200074
  • Kato Y, Nakamura K, Kitamura T, Hasegawa M, Sasaki H. Hydrophobic interaction chromatog-raphy at low salt concentration for the capture of monoclonal antibodies. J Chromatogr A 2004; 1036:45-50.
  • Kempken R, Pressman A, Berthold W. Assess-ment of a disc stack centrifuge for use in mam-malian cell separation. Biotechnol Bioeng 1995; 46:132-8
  • KP. Gagnon, Purification Tools for Monoclonal Antibodies, Validated Biosystems, Tucson, AZ, 1995.
  • L.S. Hanna, P. Pine, G. Reuzinsky, S. Nigam, D.R. Omstead, Biopharm. Int. (October) (1991) 33. R.L.
  • Liu, Hui F., et al. "Recovery and purification pro-cess development for monoclonal antibody pro-duction." MAbs. Vol. 2. No. 5. Taylor & Francis, 2010.
  • Low D, O’Leary R, Pujar NS. Future of antibody purification. J Chromatogr B 2007; 848:48-63.
  • Luo R, Waghmare R, Krishnan M, Adams C, Poon E, Kahn D. High-concentration UF/DF of a monoc-lonal antibody. Bioprocess Int 2006; 4:44-6.
  • M.A. van Dijk, J.G.J. van de Winkel, Curr. Opin. Chem. Biol. 5 (4) (2001) 368.
  • Manzke O, Tesch H, Diehl V, Bohlen H. Single-step purification of bispecific monoclonal antibo-dies for immunotherapeutic use by hydrophobic interaction chromatography. J Immunol Methods 1997; 208: 65-73.
  • Mhatre R, Nashabeh W, Schmalzing D, Yao X, Fuchs M, Whitney D, et al. Purification of antibody Fab fragments by cation-exchange chromatog-raphy and pH gradient elution. J Chromatogr A 1995; 707:225-31.
  • Nikolov ZL, Woodard SL. Downstream processing of recombinant proteins from transgenic feeds-tock. Curr Opin Biotechnol 2004; 15:479-86
  • Norling LA, Lute S, Emery R, Khuu W, Voisard M, Xu Y, et al. Impact of multi re-use of anion exchange chromatography media on virus re-moval. J Chromatogr A 2005; 1069:79-89.
  • P. Gagnon, Purification Tools for Monoclonal An-tibodies, Validated Biosystems, Tucson, AZ, 1995.
  • Porath J. Salt-promoted adsorption: recent deve-lopments. J Chromatog 1986; 376:331-41
  • R. Hahn, K. Shimahara, F. Steindl, A. Jungbauer, J. Chromatogr. A 1102 (2006) 224.
  • Reichert JM, Valge-Archer VE. Development trends for monoclonal antibody cancer therapeu-tics. Nat Rev Drug Discov 2007; 6:349-56
  • Rinderknecht E, Zapata G. Antibody purification. United States Patent Application 2002/0002271 2002.
  • S. Curtis, K. Lee, G. Blank, Y. Xu, Biotechnol. Bio-eng. 84 (2) (2003) 179.
  • S. Ghose, M. Allen, B. Hubbard, C. Brooks, S.M. Cramer, Biotechnol. Bioeng. 92 (2005) 665.
  • Shpritzer R. Evaluation of a continuous disk stack centrifuge for the clarification of mammalian cell cultures. 225th ACS National Meeting, New Orle-ans, LA 2003.
  • Shukla, Abhinav A., et al. "Downstream proces-sing of monoclonal antibodies—application of platform approaches." Journal of Chromatog-raphy B 848.1 (2007): 28-39.
  • T. Arakawa, J. Philo, K. Tsumoto, R. Yumioka, D. Ejima, Protein Express. Purif. 36 (2004) 244.
  • T. Ireland, H. Lutz, M. Siwak, G. Bolton, Biopharm. Int. 11 (2004) 38.
  • Tutunjian RS. Ultrafiltration processes in biotech-nology, in Principles of Biotechnology: Enginee-ring Considerations. Cooney CL, Humphrey AE, Editors. Pergamon Press: Elmsford, New York 1985; 411-37.
  • vanReis R, Zydney AL. Protein ultrafiltration. in Encyclopedia of Bioprocess Technology-Fermentation, Biocatalysis and Bioseparation. Flickinger MC, Drew SW, Editors. John Wiley & Sons 1999; 2197-214.
  • Wan M. Process mapping-A necessary prelude for process changing. IBC’s BioProcess Internati-onal Conference 2004; Boston MA.
  • Y. Yigzaw, R. Piper, M. Tran, A.A. Shukla, Biotech-nol. Prog. 22 (2006) 288
  • Y. Yigzaw, R. Piper, M. Tran, A.A. Shukla, Biotech-nol. Prog. 22 (2006) 288.
  • Zettlitz, K. A. (2010). Protein a/g chromatog-raphy. Antibody Engineering, 531-535. doi:10.1007/978-3-642-01144-3_34
  • Zhou JX. Development of future downstream process for commercial monoclonal antibody production. Presentation at Asia bioLogic 2007; Beijing, China
There are 56 citations in total.

Details

Primary Language Turkish
Subjects Industrial Biotechnology
Journal Section Derlemeler
Authors

Emre Burak Erkal

Dilara Baş This is me

Melisa Köprülü This is me

Melis Korkmaz This is me

Deniz Demirhan This is me

Özge Can This is me

Publication Date April 29, 2021
Published in Issue Year 2021 Volume: 4 Issue: 1

Cite

APA Erkal, E. B., Baş, D., Köprülü, M., Korkmaz, M., et al. (2021). Monoklonal Antikor Üretimleri İçin Alt Akım Prosesleri. Türkiye Sağlık Enstitüleri Başkanlığı Dergisi, 4(1), 85-96.