Identification of aggregation breakers for bevacizumab (Avastin®) self-association through similarity searching and interaction studies

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 85, Issue 3 PART A, 2013, Pages 773-780

  Westermaier, Y ^a   Veurink, M ^a   Riis Johannessen, T ^a   Guinchard, S ^a   Gurny, R ^a   Scapozza, L ^a  

^a UNIVERSITY OF GENEVA   (Switzerland)

Author keywords

Aggregation breaker; Antibody self association; Asymmetrical flow field flow fractionation; Microscale thermophoresis; Similarity searching; Size exclusion chromatography

Indexed keywords

ADENOSINE PHOSPHATE; ADENOSINE TRIPHOSPHATE; BEVACIZUMAB; DEXAMETHASONE SODIUM PHOSPHATE; GUANOSINE PHOSPHATE; PHOSPHATE; SUCROSE 6 PHOSPHATE; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; DIMERIZATION; DISSOCIATION CONSTANT; DRUG IDENTIFICATION; DRUG STABILITY; FIELD FLOW FRACTIONATION; GEL PERMEATION CHROMATOGRAPHY; MICROSCALE THERMOPHORESIS; PROTEIN PROTEIN INTERACTION;

AGGREGATION BREAKER; ANTIBODY SELF-ASSOCIATION; ASYMMETRICAL FLOW FIELD-FLOW FRACTIONATION; MICROSCALE THERMOPHORESIS; SIMILARITY SEARCHING; SIZE EXCLUSION CHROMATOGRAPHY;

ANTIBODIES, MONOCLONAL, HUMANIZED; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; COMPUTER SIMULATION; EXCIPIENTS; FRACTIONATION, FIELD FLOW; HOT TEMPERATURE; HYDROGEN-ION CONCENTRATION; MOLECULAR DOCKING SIMULATION; PROTEIN STABILITY;

EID: 84888357524     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.04.012     Document Type: Article

References (32)

1. S. Aggarwal What's fueling the biotech engine-2009-2010 Nat. Biotechnol. 28 2010 1165 1171
2. W. Wang, S.K. Singh, L. Ning, M.R. Toler, K.R. King, and S. Nema Immunogenicity of protein aggregates - concerns and realities Int. J. Pharm. 431 2012 1 11
3. J.S. Philo, and T. Arakawa Mechanisms of protein aggregation Curr. Pharm. Biotechnol. 10 2009 348 351
4. W. Wang, S. Nema, and D. Teagarden Protein aggregation - pathways and influencing factors Int. J. Pharm. 390 2010 89 99
5. A. Szenczi, J. Kardos, G.A. Medgyesi, and P. Zavodszky The effect of solvent environment on the conformation and stability of human polyclonal IgG in solution Biologicals 34 2006 5 14
6. R. Bolli, K. Woodtli, M. Bärtschi, L. Höfferer, and P. Lerch l-Proline reduces IgG dimer content and enhances the stability of intravenous immunoglobulin (IVIG) solutions Biologicals 38 2010 150 157
7. H.J. Lee, A. McAuley, K.F. Schilke, and J. McGuire Molecular origins of surfactant-mediated stabilization of protein drugs Adv. Drug. Deliv. Rev. 63 2011 1160 1171
8. J.S. Bee, T.W. Randolph, J.F. Carpenter, S.M. Bishop, and M.N. Dimitrova Effects of surfaces and leachables on the stability of biopharmaceuticals J. Pharm. Sci. 100 2011 4158 4170
9. M. Veurink, Y. Westermaier, R. Gurny, and L. Scapozza Breaking the aggregation of the monoclonal antibody bevacizumab (Avastin®) by dexamethasone phosphate: insights from molecular modelling and asymmetrical flow field-flow fractionation Pharm. Res. 30 2013 1176 1187
10. M. Veurink, C. Stella, C. Tabatabay, C.J. Pournaras, and R. Gurny Association of ranibizumab (Lucentis®) or bevacizumab (Avastin®) with dexamethasone and triamcinolone acetonide: an in vitro stability assessment Eur. J. Pharm. Biopharm. 78 2011 271 277
11. T. Rhen, and J.A. Cidlowski Antiinflammatory action of glucocorticoids - new mechanisms for old drugs N. Engl. J. Med. 353 2005 1711 1723
12. C.M. Andreoli, and J.W. Miller Anti-vascular endothelial growth factor therapy for ocular neovascular disease Curr. Opin. Ophthalmol. 18 2007 502 508
13. G. Schneider, W. Neidhart, T. Giller, and G. Schmid "Scaffold- hopping" by topological pharmacophore search: a contribution to virtual screening Angew. Chem. Int. Ed. Engl. 38 1999 2894 2896
14. G. Schneider Virtual screening for bioactive molecules by evolutionary de novo design Angew. Chem. Int. Ed. Engl. 39 2000 4130 4133
15. H.J. Boehm, A. Flohr, and M. Stahl Scaffold hopping Drug. Discov. Today 1 2004 217 224
16. J.L. Jenkins, M. Glick, and J.W. Davies A 3D similarity method for scaffold hopping from known drugs or natural ligands to new chemotypes J. Med. Chem. 47 2004 6144 6159
17. S. Renner, and G. Schneider Scaffold-hopping potential of ligand-based similarity concepts ChemMedChem. 1 2006 181 185
18. D.S. Wishart, C. Knox, A.C. Guo, D. Cheng, S. Shrivastava, D. Tzur, B. Gautam, and M. Hassanali DrugBank: a knowledgebase for drugs, drug actions and drug targets Nucleic Acids Res. 36 2008 D901 906
19. D.S. Wishart, C. Knox, A.C. Guo, S. Shrivastava, M. Hassanali, P. Stothard, Z. Chang, and J. Woolsey DrugBank: a comprehensive resource for in silico drug discovery and exploration Nucleic Acids Res. 34 2006 D668 672
20. M. Jerabek-Willemsen, C.J. Wienken, D. Braun, P. Baaske, and S. Duhr Molecular interaction studies using microscale thermophoresis Assay. Drug. Dev. Technol. 9 2011 342 353
21. J.M. Moore, T.W. Patapoff, and M.E. Cromwell Kinetics and thermodynamics of dimer formation and dissociation for a recombinant humanized monoclonal antibody to vascular endothelial growth factor Biochemistry 38 1999 13960 13967
22. T.T. Tanimoto, IBM Internal, Report, 17th November 1957.
23. P. Jaccard Distribution de la flore alpine dans le bassin des Dranses et dans quelques régions voisines Bulletin de la Société Vaudoise des Sciences Naturelles 37 1901 241 272
24. J.F. Carpenter, T.W. Randolph, W. Jiskoot, D.J.A. Crommelin, C.R. Middaugh, and G. Winter Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products J. Pharm. Sci. 99 2010 2200 2208
25. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-foods-gen/documents/ document/ucm267832.pdf.
26. G. Avigad, and P.M. Dey Carbohydrate metabolism: storage carbohydrates P.M. Dey, J.B. Harborne, Plant Biochemistry 1997 Academic Press San Diego 143 203
27. http://www.fda.gov/food/foodingredientspackaging/foodadditives/ foodadditivelisting/ucm091048.htm.
28. C.J. Wienken, P. Baaske, U. Rothbauer, D. Braun, and S. Duhr Protein-binding assays in biological liquids using microscale thermophoresis Nat. Commun. 1 2010 100
29. K. Corin, P. Baaske, D.B. Ravel, J. Song, E. Brown, X. Wang, S. Geissler, C.J. Wienken, M. Jerabek-Willemsen, S. Duhr, D. Braun, and S. Zang A robust and rapid method of producing soluble, stable, and functional G-protein coupled receptors PLoS One 6 2011 e23036
30. D. Kameoka, E. Masuzaki, T. Ueda, and T. Imoto Effect of buffer species on the unfolding and the aggregation of humanized IgG J. Biochem. 142 2007 383 391
31. R. Gurny, L. Scapozza, Y. Westermaier, M. Veurink, Stabilized intact antibody formulations, related methods and uses thereof, World Intellectual Property, Organization PCT/IB2011/051373, 2011.
32. H.C. Mahler, M. Printz, R. Kopf, R. Schuller, and R. Müller Behaviour of polysorbate 20 during dialysis, concentration and filtration using membrane separation techniques J. Pharm. Sci. 97 2008 764 774