Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development

Journal of Immunological Methods

Volumn 365, Issue 1-2, 2011, Pages 38-49

  Mikulskis, Alvydas ^a   Yeung, Dave ^a   Subramanyam, Meena ^a   Amaravadi, Lakshmi ^a  

^a BIOGEN   (United States)

Author keywords

Design of Experiments; Drug interference; Immunogenicity; Soluble target interference; Solution ELISA; Therapeutic monoclonal antibody

Indexed keywords

2,4 DINITROPHENOL; DIGOXIGENIN; DRUG ANTIBODY;

ANTIBODY LABELING; ARTICLE; CLINICAL DEVELOPMENT PLAN; DISSOCIATION; DRUG COMPETITION; DRUG TOLERANCE; ENZYME LINKED IMMUNOSORBENT ASSAY; EXPERIMENTAL DESIGN; IMMUNOGENICITY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROCESS OPTIMIZATION; SOLUTION ENZYME LINKED IMMUNOSORBENT ASSAY;

ACIDS; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL; ANTIGEN-ANTIBODY COMPLEX; CHEMILUMINESCENT MEASUREMENTS; DIGOXIGENIN; DINITROPHENOLS; DRUG DISCOVERY; ENZYME-LINKED IMMUNOSORBENT ASSAY; HAPTENS; HUMANS; SOLUTIONS; STREPTAVIDIN;

EID: 79551582036     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2010.11.011     Document Type: Article

References (31)

1. Arepally G.M., Ortel T.L. Heparin-induced thrombocytopenia. Annu. Rev. Med. 2010, 61:77.
2. Baert F., Noman M., Vermeire S., Van Assche G., D' Haens G., Carbonez A., Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N. Engl. J. Med. 2003, 348(7):601.
3. Bourdage J.S., Cook C.A., Farrington D.L., Chain J.S., Konrad R.J. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J. Immunol. Methods 2007, 327(1-2):10.
4. Casadevall N., Eckardt K.U., Rossert J. Epoetin-induced autoimmune pure red cell aplasia. J. Am. Soc. Nephrol. Suppl. 2005, 1:S67.
5. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), Biosimilar Medicianl Products Working Party (BMWP). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. EMEA/CHMP/BMWP/14327/2006 . 24 January 2007. http://www.emea.europa.eu/pdfs/human/biosimilar/1432706en.pdf.
6. The European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Medicinal Products for Human Use (CHMP), Biosimilar Medicianl Products Working Party (BMWP). Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. EMEA/CHMP/BMWP/114720/2009 . 19 March 2009. http://www.ema.europa.eu/pdfs/human/biosimilar/11472009en.pdf.
7. George J.N., Aster R.H. Drug-induced thrombocytopenia: pathogenesis, evaluation, and management. Hematology Am. Soc. Hematol. Educ. Program. 2009, 2009:153.
8. Koren E., Smith H.W., Shores E., Shankar G., Finco-Kent D., Rup B., Barrett Y.C., Devanarayan V., Gorovits B., Gupta S., Parish T., Quarmby V., Moxness M., Swanson S.J., Taniguchi G., Zuckerman L.A., Stebbins C.C., Mire-Sluis A. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 2008, 333(1-2):1.
9. Liang M., Klakamp S.L., Funelas C., Lu H., Lam B., Herl C., Umble A., Drake A.W., Pak M., Ageyeva N., Pasumarthi R., Roskos L.K. Detection of high- and low-affinity antibodies against a human monoclonal antibody using various technology platforms. Assay Drug Dev. Technol. 2007, 5(5):655.
10. Lofgren J.A., Wala I., Koren E., Swanson S.J., Jing S. Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein. J. Immunol. Methods 2006, 308(1-2):101.
11. Loyet K.M., Deng R., Liang W.C., Wu Y., Lowman H.B., DeForge L.E. Technology comparisons for anti-therapeutic antibody and neutralizing antibody assays in the context of an anti-TNF pharmacokinetic study. J. Immunol. Methods 2009, 345(1-2):17.
12. Maia, M.S., John, L., Wakshull, E., Quarmby, V., 2009. A novel strategy for elimination of soluble-ligand interference in immunogenicity assays. AAPS NBC 2009, presentation.
13. Malucchi S., Sala A., Gilli F., Bottero R., Di Sapio A., Capobianco M., Bertolotto A. Neutralizing antibodies reduce the efficacy of betaIFN during treatment of multiple sclerosis. Neurology 2004, 62(11):2031.
14. McKoy J.M., Stonecash R.E., Cournoyer D., Rossert J., Nissenson A.R., Raisch D.W., Casadevall N., Bennett C.L. Epoetin-associated pure red cell aplasia: past, present, and future considerations. Transfusion 2008, 48(8):1754.
15. Mire-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., Parish T., Scott G., Shankar G., Shores E., Swanson S.J., Taniguchi G., Wierda D., Zuckerman L.A. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 2004, 289(1-2):1.
16. Moxness M., Foley J., Stene M., Finco-Kent D., Bedian V., Krasner A., Kawabata T. Development and validation of radioligand binding assays to measure total, IgA, IgE, IgG, and IgM insulin antibodies in human serum. Ann. N. Y. Acad. Sci. 2003, 1005:265.
17. Patton A., Mullenix M.C., Swanson S.J., Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J. Immunol. Methods 2005, 304(1-2):189.
18. Ponce R., Abad L., Amaravadi L., Gelzleichter T., Gore E., Green J., Gupta S., Herzyk D., Hurst C., Ivens I.A., Kawabata T., Maier C., Mounho B., Rup B., Shankar G., Smith H., Thomas P., Wierda D. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul. Toxicol. Pharmacol. 2009, 54(2):164.
19. Rosenberg A.S., Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 2: considering host-specific and product-specific factors impacting immunogenicity. BioPharm Intl. 2004, 17:34.
20. Rosenberg A.S., Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 3: effects of manufacturing changes in immunogenicity and the utility of animal immunogenicity studies. BioPharm Intl. 2005, 18:32.
21. Shankar G., Pendley C., Stein K.E. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 2007, 25(5):555.
22. Shankar G., Devanarayan V., Amaravadi L., Barrett Y.C., Bowsher R., Finco-Kent D., Fiscella M., Gorovits B., Kirschner S., Moxness M., Parish T., Quarmby V., Smith H., Smith W., Zuckerman L.A., Koren E. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 2008, 48(5):1267.
23. Sickert D., Kroeger K., Zickler C., Chokote E., Winkler B., Grenet J.M., Legay F., Zaar A. Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore. J. Immunol. Methods 2008, 334(1-2):29.
24. Smith H.W., Butterfield A., Sun D. Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA. Regul. Toxicol. Pharmacol. 2007, 49(3):230.
25. Spengler M., Adler M., Jonas A., Niemeyer C.M. Immuno-PCR assays for immunogenicity testing. Biochem. Biophys. Res. Commun. 2009, 387(2):278.
26. Subramanyam M. Case study: immunogenicity of natalizumab. Immunogenicity of Biopharmaceuticals 2008, 173. Springer, New York, vol. 8. M. Van De Weert, E.H. Møller (Eds.).
27. U.S. Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research. Guidance for industry: assay development for immunogenicity testing of therapeutic proteins (draft guidance). . December 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf.
28. Wang J., Lozier J., Johnson G., Kirshner S., Verthelyi D., Pariser A., Shores E., Rosenberg A. Neutralizing antibodies to therapeutic enzymes: considerations for testing, prevention and treatment. Nat. Biotechnol. 2008, 26(8):901.
29. White J.T., Martell L.A., Van Tuyl A., Boyer R., Warness L., Taniguchi G.T., Foehr E. Development, validation, and clinical implementation of an assay to measure total antibody response to naglazyme (galsulfase). AAPS J. 2008, 10(2):363.
30. Worobec A., Rosenberg A.S. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 1: considering consequences of the immune response to a protein. BioPharm Intl. 2004, 17:22.
31. Zhong Z.D., Dinnogen S., Hokom M., Ray C., Weinreich D., Swanson S.J., Chirmule N. Identification and inhibition of drug target interference in immunogenicity assays. J. Immunol. Methods 2010, 355(1-2):21.