A Neutralizing Antibody Assay Based on a Reporter of Antibody-Dependent Cell-Mediated Cytotoxicity

AAPS Journal

Volumn 17, Issue 6, 2015, Pages 1417-1426

  Wu, Yuling ^a   Li, Jia J ^a   Kim, Hyun Jun ^a   Liu, Xu ^a   Liu, Weiyi ^a   Akhgar, Ahmad ^a   Bowen, Michael A ^a   Spitz, Susan ^a   Jiang, Xu Rong ^a   Roskos, Lorin K ^a   White, Wendy I ^a  

^a MEDIMMUNE   (United States)

Author keywords

ADCC; benralizumab; cell based assay; mechanism of action; neutralizing antibody

Indexed keywords

BENRALIZUMAB; BENRALIZUMAB ANTIBODY; CD16 ANTIGEN; INTERLEUKIN 5; INTERLEUKIN 5 RECEPTOR; NATURAL KILLER CELL RECEPTOR; NATURAL KILLER CELL RECEPTOR NK92; NEUTRALIZING ANTIBODY; TRANSCRIPTION FACTOR NFAT; UNCLASSIFIED DRUG; MONOCLONAL ANTIBODY;

AFUCOSYLATION; ANIMAL CELL; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; ANTIBODY DETECTION; ARTICLE; ASTHMA; BINDING AFFINITY; CLINICAL ARTICLE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG PROTEIN BINDING; DRUG SYNTHESIS; EC80; EFFECTIVE CONCENTRATION; EFFECTOR CELL; FEASIBILITY STUDY; FEMALE; HUMAN; HUMAN CELL; IMMUNOASSAY; MALE; NONHUMAN; PHYSICAL PARAMETERS; PILOT STUDY; SENSITIVITY ANALYSIS; SIGNAL NOISE RATIO; TARGET CELL; ANIMAL; BLOOD; CELL LINE; DRUG EFFECTS; METABOLISM; MOUSE; NATURAL KILLER CELL; PHYSIOLOGY;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIBODIES, NEUTRALIZING; ANTIBODY-DEPENDENT CELL CYTOTOXICITY; CELL LINE; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; KILLER CELLS, NATURAL; MICE;

EID: 84945454142     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9798-5     Document Type: Article

References (19)

1. Eugen K, Holly WS, Elizabeth S, Gopi S. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods. 2008;333:1–9.
2. Swanson SJ. Immunogenicity issues in drug development. J Immunotoxicol. 2006;3:165–72.
3. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346:469–75.
4. Vultaggio A, Maggi E, Matucci A. Immediate adverse reactions to biologicals: from pathogenic mechanisms to prophylactic management. Curr Opin Allergy Clin Immunol. 2011;11:262–8.
5. Food and Drug administration. DRAFT. Guidance for industry assay development for immunogenicity testing of therapeutic proteins. U.S. Department of Health and Human Services; 2009.
6. Lallemand C, Meritet JF, Blanchard B, Lebon P, Tovey MG. One-step assay for quantification of neutralizing antibodies to biopharmaceuticals. J Immunol Methods. 2010;356:18–28.
7. Ryding J, Hjertberg E, Rasmussen BB. Comparison of two direct neutralizing assay formats using recombinant follicle-stimulating hormone as agonist. J Immunol Methods. 2013;400-1:87–96.
8. Jiang XR, Song A, Bergelson S, Arroll T, Parekh B, May K, et al. Advances in the assessment and control of the effector functions of therapeutic antibodies. Nat Rev Drug Discov. 2011;10:101–11.
9. Chan AC, Carter PJ. Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol. 2010;10:301–16.
10. Chung S, Quarmby V, Gao X, Ying Y, Lin L, Reed C, et al. Quantitative evaluation of fucose reducing effects in a humanized antibody on Fcγ receptor binding and antibody-dependent cell-mediated cytotoxicity activities. MAbs. 2012;4:326–40.
11. Wu YL, Liu X, Chen Y, Woods R, Lee N, Yang H, et al. An electrochemiluminescence (ECL)-based assay for the specific detection of anti-drug antibodies of the IgE isotype. J Pharm Biomed Anal. 2013;86:73–81.
12. Shinkawa T, Nakamura K, Yamane N, Shoji-Hosaka E, Kanda Y, Sakurada M, et al. The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity. J Biol Chem. 2003;278:3466–73.
13. Kolbeck R, Kozhich A, Koike M, Peng L, Andersson CK, Damschroder MM, et al. MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125:1344–53.
14. Finco D, Baltrukonis D, Clements-Egan A, Delaria K, Gunn GR, Lowe J, et al. Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics. J Pharm Biomed Anal. 2011;54:351–8.
15. Deehan M, Garcês S, Kramer D, Baker MP, Rat D, Roettger Y, et al. Managing unwanted immunogenicity of biologicals. Autoimmun Rev. 2015;14:569–74.
16. Schwickart M, Mehrzai F, Pearson J, Shaghasi N, Chavez C, Schneider A, et al. Identification and elimination of target-related matrix interference in a neutralizing anti-drug antibody assay. J Immunol Methods. 2013;1759:343–8.
17. Sanchez S, Barger T, Zhou L, Hale H, Mytych D, Gupta S, et al. Strategy to confirm the presence of anti-erythropoietin neutralizing antibodies in human serum. J Pharm Biomed Anal. 2011;55:1265–74.
18. Liao K, Sikkema D, Wang C, Chen K, DeWall S, Lee TN. Development and validation of a cell-based SEAP reporter assay for the detection of neutralizing antibodies against an anti-IL-13 therapeutic antibody. J Immunol Methods. 2012;375:258–63.
19. Boise LH, McShan CL, Thompson CB. Introduction of the cell survival gene bcl-xL improves the viability of CTLL-2 cells without affecting their IL-2 proliferative response. Implications for the development of bioassays. J Immunol Methods. 1996;191:143–8.