Characterization of acidic and basic variants of IgG1 therapeutic monoclonal antibodies based on non-denaturing IEF fractionation

Electrophoresis

Volumn 36, Issue 21-22, 2015, Pages 2695-2702

  Dada, Oluwatosin O ^a   Jaya, Nomalie ^a   Valliere Douglass, John ^a   Salas Solano, Oscar ^a  

^a SEATTLE GENETICS INC   (United States)

Author keywords

Antibodies drug conjugates; Charge variants; IgG1; IPG; Isoelectric focusing

Indexed keywords

AMINO ACIDS; CHEMICAL MODIFICATION; ELECTROPHORESIS; FOCUSING;

ANTIBODY-DRUG CONJUGATES; CAPILLARY ISOELECTRIC FOCUSING; CHARGE VARIANTS; DEAMIDATION; FOCUSING PROFILES; IGG1; IPG; ISOELECTRIC FOCUSING; PH GRADIENTS; THERAPEUTIC MONOCLONAL ANTIBODIES;

MONOCLONAL ANTIBODIES;

GLUTAMINE; IMMUNOGLOBULIN G1 ANTIBODY; LYSINE; METHYLGLYOXAL; PROLINE;

ACIDITY; ALKALINITY; AMIDATION; AMINO TERMINAL SEQUENCE; ARTICLE; CARBOXY TERMINAL SEQUENCE; CHEMICAL MODIFICATION; CONTROLLED STUDY; DEAMINATION; DRUG DETERMINATION; FRACTIONATION; GLYCATION; ISOELECTRIC FOCUSING; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; SIALYLATION;

EID: 84947863038     PISSN: 01730835     EISSN: 15222683     Source Type: Journal    
DOI: 10.1002/elps.201500219     Document Type: Article

References (38)

1. Goldenberg, D. M., Sharkey, R. M., Expert Opin. Biol. Ther. 2012, 12, 1173-1190.
2. Sidhu, S. S., Nat. Biotechnol. 2007, 25, 537-538.
3. Harris, R. J., J. Chromatogr. A 1995, 705, 129-134.
4. Harris, R. J., Kabakoff, B., Macchi, F. D., Shen, F. J., Kwong, M., Andya, J. D., Shire, S. J., Bjork, N., Totpal, K., Chen, A. B., J. Chromatogr. B Biomed. Sci. Appl. 2001, 752, 233-245.
5. Yan, B., Steen, S., Hambly, D., Valliere-Douglass, J., Vanden Bos, T., Smallwood, S., Yates, Z., Arroll, T., Han, Y., Gadgil, H., Latypov, R. F., Wallace, A., Lim, A., Kleemann, G. R., Wang, W., Balland, A., J. Pharm. Sci. 2009, 98, 3509-3521.
6. Valliere-Douglass, J. F., Brady, L. J., Farnsworth, C., Pace, D., Balland, A., Wallace, A., Wang, W., Treuheit, M. J., Yan, B., Glycobiology 2009, 19, 144-152.
7. Perkins, M., Theiler, R., Lunte, S., Jeschke, M., Pharm. Res. 2000, 17, 1110-1117.
8. Khawli, L. A., Goswami, S., Hutchinson, R., Kwong, Z. W., Yang, J., Wang, X., Yao, Z., Sreedhara, A., Cano, T., Tesar, D., Nijem, I., Allison, D. E., Wong, P. Y., Kao, Y. H., Quan, C., Joshi, A., Harris, R. J., Motchnik, P., mAbs 2010, 2, 613-624.
9. Brobey, R. K., Soong, L., Proteomics 2007, 7, 116-120.
10. Zhang, T., Bourret, J., Cano, T., J. Chromatogr. A 2011, 1218, 5079-5086.
11. Vlasak, J., Ionescu, R., Curr. Pharm. Biotechnol. 2008, 9, 468-481.
12. Liu, H., Gaza-Bulseco, G., Faldu, D., Chumsae, C., Sun, J., J. Pharm. Sci. 2008, 97, 2426-2447.
13. Michels, D. A., Tu, A. W., McElroy, W., Voehringer, D., Salas-Solano, O., Anal. Chem. 2012, 84, 5380-5386.
14. Salas-Solano, O., Kennel, B., Park, S. S., Roby, K., Sosic, Z., Boumajny, B., Free, S., Reed-Bogan, A., Michels, D., McElroy, W., Bonasia, P., Hong, M., He, X., Ruesch, M., Moffatt, F., Kiessig, S., Nunnally, B., J. Sep. Sci. 2012, 35, 3124-3129.
15. Sosic, Z., Houde, D., Blum, A., Carlage, T., Lyubarskaya, Y., Electrophoresis 2008, 29, 4368-4376.
16. Cargile, B. J., Talley, D. L., Stephenson, J. L., Jr., Electrophoresis 2004, 25, 936-945.
17. Horth, P., Miller, C. A., Preckel, T., Wenz, C., Mol. Cell. Proteomics 2006, 5, 1968-1974.
18. Meert, C. D., Brady, L. J., Guo, A., Balland, A., Anal. Chem. 2010, 82, 3510-3518.
19. Liu, H. F., Ma, J., Winter, C., Bayer, R., mAbs 2010, 2, 480-499.
20. Rustandi, R. R., Washabaugh, M. W., Wang, Y., Electrophoresis 2008, 29, 3612-3620.
21. Vlasak, J., Ionescu, R., mAbs 2011, 3, 253-263.
22. Aswad, D. W., Paranandi, M. V., Schurter, B. T., J. Pharm. Biomed. Anal. 2000, 21, 1129-1136.
23. Oliyai, C., Borchardt, R. T., Pharm. Res. 1994, 11, 751-758.
24. Robinson, N. E., Robinson, A. B., Proc. Natl. Acad. Sci. U S A 2001, 98, 12409-12413.
25. Santora, L. C., Krull, I. S., Grant, K., Anal. Biochem. 1999, 275, 98-108.
26. Zheng, J. Y., Janis, L. J., Int. J. Pharm. 2006, 308, 46-51.
27. Kaschak, T., Boyd, D., Yan, B., Anal. Biochem. 2011, 417, 256-263.
28. Yuk, I. H., Zhang, B., Yang, Y., Dutina, G., Leach, K. D., Vijayasankaran, N., Shen, A. Y., Andersen, D. C., Snedecor, B. R., Joly, J. C., Biotechnol. Bioeng. 2011, 108, 2600-2610.
29. Chumsae, C., Gifford, K., Lian, W., Liu, H., Radziejewski, C. H., Zhou, Z. S., Anal. Chem. 2013, 85, 11401-11409.
30. Du, Y., Walsh, A., Ehrick, R., Xu, W., May, K., Liu, H., mAbs 2012, 4, 578-585.
31. Johnson, K. A., Paisley-Flango, K., Tangarone, B. S., Porter, T. J., Rouse, J. C., Anal. Biochem. 2007, 360, 75-83.
32. Kaschak, T., Boyd, D., Lu, F., Derfus, G., Kluck, B., Nogal, B., Emery, C., Summers, C., Zheng, K., Bayer, R., Amanullah, A., Yan, B., mAbs 2011, 3, 577-583.
33. Tsubaki, M., Terashima, I., Kamata, K., Koga, A., Int. J. Biol. Macromol. 2013, 52, 139-147.
34. Bradbury, A. F., Smyth, D. G., Biosci. Rep. 1987, 7, 907-916.
35. Dick, L. W., Jr., Kim, C., Qiu, D., Cheng, K. C., Biotechnol. Bioeng. 2007, 97, 544-553.
36. Lyubarskaya, Y., Houde, D., Woodard, J., Murphy, D., Mhatre, R., Anal. Biochem. 2006, 348, 24-39.
37. Liu, Y. D., Goetze, A. M., Bass, R. B., Flynn, G. C., J. Biol. Chem. 2011, 286, 11211-11217.
38. Ionescu, R., Vlasak, J., Anal. Chem. 2010, 82, 3198-3206.