Development and validation of a novel SPR-based assay principle for bispecific molecules

Journal of Pharmaceutical and Biomedical Analysis

Volumn 102, Issue , 2015, Pages 144-149

  Gassner, C ^a   Lipsmeier, F ^b   Metzger, P ^c   Beck, H ^c   Schnueriger, A ^c   Regula, J T ^a   Moelleken, J ^a  

^a Roche Innovation Center Penzberg   (Germany)

^b pRED Informatics Pharma Research and Early Development Roche Innovation Center Penzberg   (Germany)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Activity assessment; Binding assay; Bispecific antibody; Bridging assay; Surface plasmon resonance

Indexed keywords

ANGIOPOIETIN 2; ANGIOPOIETIN 2 ANTIBODY; BISPECIFIC ANTIBODY; PROTEIN ANTIBODY; UNCLASSIFIED DRUG; VASCULOTROPIN; VASCULOTROPIN A ANTIBODY; VASCULOTROPIN A; VEGFA PROTEIN, HUMAN;

ACCURACY; ANTIGEN BINDING; ARTICLE; BINDING AFFINITY; CONTROLLED STUDY; IMMUNOASSAY; IMMUNOASSAY ANALYZER; PROTEIN BINDING; QUALITY CONTROL; SURFACE PLASMON RESONANCE; VALIDATION STUDY; BIOLOGICAL MODEL; DOSE RESPONSE; HUMAN; METABOLISM;

ANGIOPOIETIN-2; ANTIBODIES, BISPECIFIC; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MODELS, IMMUNOLOGICAL; SURFACE PLASMON RESONANCE; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84907863312     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2014.09.007     Document Type: Article

References (25)

1. Schaefer W., Regula J.T., Bahner M., Schanzer J., Croasdale R., Durr H., Gassner C., Georges G., Kettenberger H., Imhof-Jung S., Schwaiger M., Stubenrauch K.G., Sustmann C., Thomas M., Scheuer W., Klein C. Immunoglobulin domain crossover as a generic approach for the production of bispecific IgG antibodies. Proc. Natl. Acad. Sci. U. S. A. 2011, 108:11187-11192.
2. Oliner J., Min H., Leal J., Yu D., Rao S., You E., Tang X., Kim H., Meyer S., Han S.J. Suppression of angiogenesis and tumor growth by selective inhibition of angiopoietin-2. Cancer Cell 2004, 6:507-516.
3. Ferrara N. VEGF as a therapeutic target in cancer. Oncology 2005, 69:11-16.
4. Schuck P. Use of surface plasmon resonance to probe the equilibrium and dynamic aspects of interactions between biological macromolecules 1. Annu. Rev. Biophys. Biomol. Struct. 1997, 26:541-566.
5. Rich R.L., Myszka D.G. Why you should be using more SPR biosensor technology. Drug Discov. Today: Technol. 2004, 1:301-308.
6. Huber W., Mueller F. Biomolecular interaction analysis in drug discovery using surface plasmon resonance technology. Curr. Pharm. Des. 2006, 12:3999-4021.
7. Phillips K.S., Cheng Q. Recent advances in surface plasmon resonance based techniques for bioanalysis. Anal. Bioanal. Chem. 2007, 387:1831-1840.
8. Thillaivinayagalingam P., Gommeaux J., McLoughlin M., Collins D., Newcombe A.R. Biopharmaceutical production: applications of surface plasmon resonance biosensors. J. Chromatogr. B 2010, 878:149-153.
9. Deckert F., Legay F. Development and validation of an immunoreceptor assay for simulect based on surface plasmon resonance. Anal. Biochem. 1999, 274:81-89.
10. Deckert F., Legay F. Development and validation of an IL-6 immuno-receptor assay based on surface plasmon resonance. J. Pharm. Biomed. Anal. 2000, 23:403-412.
11. Reynhardt K.O., Subramanayam M. Biacore's SPR technology in a GMP-regulated environment. Biacore J. 2001, 1:12-14.
12. DiGiacomo R.A., Xie L., Cullen C., Indelicato S.R. Development and validation of a kinetic assay for analysis of anti-human interleukin-5 monoclonal antibody (SCH 55700) and human interleukin-5 interactions using surface plasmon resonance. Anal. Biochem. 2004, 327:165-175.
13. McCormick A.N., Leach M.E., Savidge G., Alhaq A. Validation of a quantitative SPR assay for recombinant FVIII. Clin. Lab. Haematol. 2004, 26:57-64.
14. Wang H., Shi J., Wang Y., Cai K., Wang Q., Hou X., Guo W., Zhang F. Development of biosensor-based SPR technology for biological quantification and quality control of pharmaceutical proteins. J. Pharm. Biomed. Anal. 2009, 50:1026-1029.
15. Mason S., La S., Mytych D., Swanson S.J., Ferbas J. Validation of the BIACORE 3000 platform for detection of antibodies against erythropoietic agents in human serum samples. Curr. Med. Res. Opin. 2003, 19:651-659.
16. Szolar O.H., Stranner S., Zinoecker I., Mudde G.C., Himmler G., Waxenecker G., Nechansky A. Qualification and application of a surface plasmon resonance-based assay for monitoring potential HAHA responses induced after passive administration of a humanized anti Lewis-Y antibody. J. Pharm. Biomed. Anal. 2006, 41:1347-1353.
17. Mytych D.T., La S., Barger T., Ferbas J., Swanson S.J. The development and validation of a sensitive, dual-flow cell, SPR-based biosensor immunoassay for the detection, semi-quantitation, and characterization of antibodies to darbepoetin alfa and epoetin alfa in human serum. J. Pharm. Biomed. Anal. 2009, 49:415-426.
18. Cooper M.A. Optical biosensors in drug discovery. Nat. Rev. Drug Discov. 2002, 1:515-528.
19. Validation of a concentration Assay using Biacore C. Application Note 48 2003, GE Healthcare.
20. Harrison A., Liu Z., Makweche S., Maskell K., Qi H., Hale G. Methods to measure the binding of therapeutic monoclonal antibodies to the human Fc receptor FcgammaRIII (CD16) using real time kinetic analysis and flow cytometry. J. Pharm. Biomed. Anal. 2012, 63:23-28.
21. Chamberlain P. The Role of Immunoassays and Bioassays in Biopharmaceutical Development: An Overview for Regulatory Specialists [February]. TOPRA 2006.
22. Rieder N., Gazzano-Santoro H., Schenerman M., Strause R., Fuchs C., Mire-Sluis A. The roles of bioactivity assays in lot release and stability testing. BioProcess Int. 2010, 8.
23. Robinson C.J., Jones C. Quality control and analytical techniques for biopharmaceuticals. Bioanalysis 2011, 3:81-95.
24. Vashist S.K. Effect of antibody modifications on its biomolecular binding as determined by surface plasmon resonance. Anal. Biochem. 2012, 421:336-338.
25. Mire-Sluis A.R. Progress in the use of biological assays during the development of biotechnology products. Pharm. Res. 2001, 18:1239-1246.