Analysis of recombinant monoclonal antibodies by capillary zone electrophoresis

Electrophoresis

Volumn 34, Issue 8, 2013, Pages 1133-1140

  Espinosa de la Garza, Carlos E ^a   Perdomo Abúndez, Francisco C ^a   Padilla Calderón, Jesús ^a   Uribe Wiechers, Jaime M ^a   Pérez, Néstor O ^a   Flores Ortiz, Luis F ^a   Medina Rivero, Emilio ^a  

^a Probiomed SA de CV   (Mexico)

Author keywords

Biosimilars; CZE; Monoclonal antibodies

Indexed keywords

CAPILLARY ELECTROPHORESIS; SURFACE PLASMON RESONANCE;

BIOSIMILAR; CAPILLARY-ZONE ELECTROPHORESIS; CHARGE HETEROGENEITY; CZE; ISOFORMS; NATIVE STATE; PROTEIN MOIETY; QUALITY ATTRIBUTES; RECOMBINANT MONOCLONAL ANTIBODY; THERAPEUTIC PROTEIN;

MONOCLONAL ANTIBODIES;

BEVACIZUMAB; INFLIXIMAB; KIKUZUBAM; RANIBIZUMAB; RITUXIMAB; TRASTUZUMAB; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ANALYTICAL PARAMETERS; ARTICLE; CAPILLARY LIFETIME; CAPILLARY ZONE ELECTROPHORESIS; CONTROLLED STUDY; DRUG IDENTIFICATION; INTERMETHOD COMPARISON; PEAK TAILING;

EID: 84876335259     PISSN: 01730835     EISSN: 15222683     Source Type: Journal    
DOI: 10.1002/elps.201200575     Document Type: Article

References (21)

1. Reichert, J. M., Curr. Pharm. Biotechnol. 2008, 9, 423-430.
2. Carter, P., Nat. Rev. Inmunol. 2006, 6, 343-357.
3. Reubsaet, J. L. E., Beijnen, J. H., Bult, A., van Maanen, R. J., Marchal, J. A. D., Undergerg, W. J. M., J. Pharm. Biomed. Anal. 1998, 17, 955-978.
4. Reubsaet, J. L. E., Beijnen, J. H., Bult, A., van Maanen, R. J., Marchal, J. A. D., Undergerg, W. J. M., J. Pharm. Biomed. Anal. 1998, 17, 979-984.
5. Dillon, T. M., Ricci, M. S., Vezina, C., Flynn, G. C., Liu, Y. D., Rehder, D. S., Plant, M., Henkle, B., Li, Y., Deechongkit, S., Varnum, B., Wypych, J., Ballard, A., Bondarenko, P. V., J. Biol. Chem. 2008, 283, 16206-16215.
6. Liu, H., Gaza-Bulseco, G., Faldu, D., Chumsae, C., Sun, J., J. Pharmaceut. Sci. 2008, 97, 2426-2447.
7. Ma, S., Nashbeh, W., Chromatographia 2001, 53, S75-S89.
8. He, Y., Lacher, N. A., Hou, W., Wang, Q., Isele, C., Starkey, J., Ruesch, M., Anal. Chem. 2010, 82, 3222-3230.
9. He, Y., Isele, C., Hou, W., Ruesch, M. N., J. Sep. Sci. 2011, 34, 548-555.
10. Han, H., Livingston, E., Chen, X., Anal. Chem. 2011, 83, 8184-8191.
11. Haselberg, R., de Jong, G. J., Somsen, G. W., J. Chromatogr. A 2007, 1159, 81-109.
12. Salas-Solano, O., Felten, C., in: Ahuja, S., Jimidar, M. I. (Eds.), Capillary Electrophoresis Methods for Pharmaceutical Analysis, Elsevier, Amsterdam 2008, pp. 401-424.
13. Staub, A., Guillarme, D., Schappler, J., Veuthey, J. L., Rudaz, S., J. Pharmaceut. Biomed. Anal. 2011, 55, 810-822.
14. Staub, A., Comte, S., Rudaz, S., Veuthey, J. L., Schappler, J., Electrophoresis 2010, 31, 3326-3333.
15. Dette, C., Wätzig, H., Uhl, H., Pharmazie 1993, 48, 276-280.
16. Wätzig, H., Degenhardt, M., Kunkel, A., Electrophoresis 1998, 19, 2695-2752.
17. Ghosal, S., Chen, Z., J. Fluid Mech. 2012, 697, 436-454.
18. Wätzig, H., Günter, S., Clin. Chem. Lab. Med. 2003, 41, 724-738.
19. Li, S. K., Liddell, M. R., Wen, H., J. Pharm. Biomed. Anal. 2011, 55, 603-607.
20. Lacher, N. A., Roberts, R. K., He, Y., Cargill, H., Kearns, K. M., Holovics, H., Ruesch, M. N., J. Sep. Sci. 2010, 33, 1-10.
21. ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, Q2(R1), ICH Secretariat, Geneva, Switzerland 2005.