Investigation into temperature-induced aggregation of an antibody drug conjugate

Bioconjugate Chemistry

Volumn 24, Issue 10, 2013, Pages 1674-1683

  Beckley, Nia S ^a   Lazzareschi, Kathlyn P ^a   Chih, Hung Wei ^a   Sharma, Vikas K ^a   Flores, Heather L ^a  

^a GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINO ACIDS; DICHROISM; DIFFERENTIAL SCANNING CALORIMETRY; STRESS ANALYSIS; SULFUR COMPOUNDS; THERMAL STRESS;

% REDUCTIONS; ANTIBODY-DRUG CONJUGATES; CHROMATOGRAPHIC METHODS; HIGH DRUG LOADINGS; HIGH MOLECULAR WEIGHT; INTRINSIC TRYPTOPHAN FLUORESCENCES; PHYSICAL STABILITY; SECONDARY AND TERTIARY STRUCTURES; SECONDARY STRUCTURES; TEMPERATURE-INDUCED;

ANTIBODIES;

ANTIBODY DRUG CONJUGATE; DISULFIDE; DRUG ANTIBODY; TRYPTOPHAN; UNCLASSIFIED DRUG; VEDOTIN;

ARTICLE; CIRCULAR DICHROISM; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG CONJUGATION; ELECTROPHORESIS; FLUORESCENCE; GEL PERMEATION CHROMATOGRAPHY; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; MOLECULAR WEIGHT; REDUCTION; REVERSED PHASE LIQUID CHROMATOGRAPHY; SEQUENCE HOMOLOGY; TEMPERATURE DEPENDENCE; TEMPERATURE STRESS; ULTRAVIOLET RADIATION;

ANTIBODIES, MONOCLONAL, HUMANIZED; DISULFIDES; HUMANS; IMMUNOCONJUGATES; IMMUNOGLOBULIN G; OLIGOPEPTIDES; PROTEIN STABILITY; PROTEIN STRUCTURE, SECONDARY; PROTEIN STRUCTURE, TERTIARY; TEMPERATURE;

EID: 84885993126     PISSN: 10431802     EISSN: 15204812     Source Type: Journal    
DOI: 10.1021/bc400182x     Document Type: Article

References (21)

1. Zhang, Q., Chen, G., Liu, X., and Qian, Q. (2007) Review Monoclonal antibodies as therapeutic agents in oncology and antibody gene therapy Cell Res. 17, 89-99
2. Feld, J., Barta, S. K., Schinke, C., Braunschweig, I., Zhou, Y., and Verma, A. K. (2013) Linked-in: design and efficacy of antibody drug conjugates in oncology Oncotargets Ther. 4, 397-412
3. Slamon, D. J., Leyland-Jones, B., Shak, S., Fuchs, H., Paton, V., Bajamonde, A., Fleming, T., Eiermann, W., Wolter, J., Pegram, M., Baselga, J., and Norton, L. (2001) Use of chemotherapy plus a monoclonal ADC against HER2 for metastatic breast cancer that overexpresses HER2 N. Engl. J. Med. 344, 783-792
4. Kemshead, J. T. and Hopkins, K. (1993) Uses and limitations of monoclonal antibodies (MoAbs) in the treatment of malignant disease: a review J. R. Soc. Med. 86, 219-224
5. Singh, R. and Erickson, H. K. (2009) Antibody-cytotoxic agent conjugates: preparation and characterization Methods Mol. Biol. (N. Y., NY, U. S.) 525, 445-467
6. Ritter, A. (2012) Antibody-drug conjugates: looking ahead to an emerging class of biotherapeutics Pharm. Technol. 36, 42-47
7. Erickson, H. K., Park, P. U., Widdison, W. C., Kovtun, Y. V., Garrett, L. M., Hoffman, K., Lutz, R. J., Goldmacher, V. S., and Blattler, W. A. (2006) Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing Cancer Res. 66, 4426-4433
8. Kung Sutherland, M. S., Sanderson, R. J., Gordon, K. A., Andreyka, J., Cerveny, C. G., Yu, C., Lewis, T. S., Meyer, D. L., Zabinski, R. F., Dorolina, S. O., Senter, P. D., Law, C. L., and Wahl, A. F. (2006) Lysosomal trafficking and cysteine protease metabolism confer target-specific cytotoxicity by peptide-linked anti-CD30-auristatin conjugates J. Biol. Chem. 281, 10540-10547
9. Doronina, S. O., Mendelsohn, B. A., Bovee, T. D., Cerveny, C. G., Meyer, D. L., Oflazoglu, E., Toki, B. E., Sanderson, R. J., Zabinski, R. F., Wahl, A. F., and Senter, P. D. (2006) Enhanced activity of monomethylauristatin F through monoclonal antibody delivery: effects of linker technology on efficacy and toxicity Bioconjugate Chem. 17, 114-124
10. Hamann, P. R., Hinman, L. M., Beyer, C. F., Lindh, D., Upeslacis, J., Flowers, D. A., and Bernstein, I. (2002) An anti-CD33 antibody-calicheamicin conjugate for treatment of acute myeloid leukemia. Choice of linker Bioconjugate Chem. 13, 40-46
11. Junutula, J. R., Raab, H., Clark, S., Bhakta, S., Leipold, D. D., Weir, S., Chen, Y., Simpson, M., Tsai, S. P., Dennis, M. S., Lu, Y., Meng, Y. G., Ng, C., Yang, J., Lee, C. C., Duenas, E., Gorrell, J., Katta, V., Kim, A., McDorman, K., Flagella, K., Venook, R., Ross, S., Spencer, S. D., Wong, W. L., Lowman, H. B., Vandlen, R., Sliwkowski, M. X., Scheller, R. H., Polakis, P., and Mallet, W. (2008) Site-specific conjugation of a cytotoxic drug to an antibody improves the therapeutic index Nat. Biotechnol. 26, 925-32
12. Food and Drug Administration. ((2013) FDA approves new treatment for late-stage breast cancer. [Press release]. Retrieved from http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm340704.htm.
13. Le, L. N., Moore, J. M. R., Ouyang, J., Chen, X., Nguyen, M. D. H., and Galush, W. J. (2012) Profiling antibody drug conjugate positional isomers: a system-of-equations approach Anal. Chem. 84, 7479-7486
14. Seegan, G. W., Smith, C. A., and Schumaker, V. N. (1979) Changes in quaternary structure of IgG upon reduction of the inter heavy-chain disulfide bond Proc. Natl. Acad. Sci. U.S.A. 76, 907-911
15. Hamblett, K. J., Senter, P. D., Chace, D. F., Sun, M. M. C., Lenox, J., Cerveny, C. G., Kissler, K. M., Bernhardt, S. X., Kopcha, A. K., Zabinski, R. F., Meyer, D. L., and Francisco, J. A. (2004) Effects of drug loading on the antitumor activity of a monoclonal antibody drug conjugate Clin. Cancer Res. 10, 7063-7070
16. Ionescu, R. M., Vlasak, J., Price, C., and Kirchmeier, M. (2008) Contribution of variable domains to the stability of humanized IgG1 monoclonal antibodies J. Pharm. Sci. 97, 1414-1426
17. Francisco, J. A., Cerveny, C. G., Meyer, D. L., Mixan, B. J., Klussman, K., Chace, D. F., Rejniak, S. X., Gordon, K. A., DeBlanc, R., Toki, B. E., Law, C. L., Doronina, S. O., Siegall, C. B., Senter, P. D., and Wahl, A. F. (2003) cAC10-vcMMAE, an anti-CD30-monomethyl auristatin E conjugate with potent and selective antitumor activity Blood 102, 1458-1465
18. Wakankar, A., Chen, Y., Gokarn, Y., and Jacobson, F. S. (2011) Analytical methods for physicochemical characterization of antibody drug conjugates MAbs 3, 161-172
19. Vivian, J. T. and Callis, P. R. (2001) Mechanisms of tryptophan fluorescence shifts in proteins Biophys. J. 80, 2093-3109
20. Hermeling, S., Crommelin, D. J., Schellekens, H., and Jiskoot, W. (2004) Structure-immunogenicity relationships of therapeutic proteins Pharm. Res. 21, 897-903
21. Cromwell, M. E. M., Hilario, E., and Jacobson, F. (2006) Protein aggregation and bioprocessing AAPS J. 8, E572-E579