Minimizing target interference in PK immunoassays: New approaches for low-pH-sample treatment

Bioanalysis

Volumn 5, Issue 15, 2013, Pages 1897-1910

  Partridge, Michael A ^a   Pham, John ^a   Dziadiv, Olena ^a   Luong, Onson ^a   Rafique, Ashique ^a   Sumner, Giane ^a   Torri, Albert ^a  

^a REGENERON PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETIC ACID; ANGIOPOIETIN 2; IMMUNOGLOBULIN G ANTIBODY; NESVACUMAB; REGN 1500; UNCLASSIFIED DRUG;

ACIDIFICATION; ANTIBODY DETECTION; ARTICLE; CONTROLLED STUDY; DILUTION; DISSOCIATION; DRUG BINDING; DRUG DETERMINATION; DRUG INTERACTION; DRUG TARGETING; ENZYME LINKED IMMUNOSORBENT ASSAY; PH; PHARMACOKINETICS; SANDWICH ENZYME LINKED IMMUNOSORBENT ASSAY; TARGET CAPTURE ENZYME LINKED IMMUNOSORBENT ASSAY;

ACETIC ACID; ANGIOPOIETIN-2; ANIMALS; ANTIBODIES, MONOCLONAL; DRUG MONITORING; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; HYDROGEN-ION CONCENTRATION; LIMIT OF DETECTION; MACACA FASCICULARIS; QUALITY CONTROL; REFERENCE STANDARDS; SOLUBILITY; SURFACE PLASMON RESONANCE;

EID: 84881279097     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.128     Document Type: Article

References (19)

1. Nishimoto N, Terao K, Mima T, Nakahara H, Takagi N, Kakehi T. Mechanisms and pathologic significances in increase in serum interleukin-6 (IL-6) and soluble IL-6 receptor after administration of an anti-IL-6 receptor antibody, tocilizumab, in patients with rheumatoid arthritis and Castleman disease. Blood 112(10), 3959-3964 (2008).
2. Salimi-Moosavi H, Lee J, Desilva B, Doellgast G. Novel approaches using alkaline or acid/guanidine treatment to eliminate therapeutic antibody interference in the measurement of total target ligand. J. Pharm. Biomed. Anal. 51(5), 1128-1133 (2010).
3. Doucet J, Avrameas A. A novel method for quantitative measurement of a therapeutic monoclonal antibody in the presence of its target protein using enzymatic digestion. J. Pharm. Biomed. Anal. 52(4), 565-570 (2010).
4. Lee JW, Kelley M, King LE et al. Bioanalytical approaches to quantify 'total' and 'free' therapeutic antibodies and their targets: Technical challenges and PK/PD applications over the course of drug development. AAPS J. 13(1), 99-110 (2011).
5. Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. 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 327(1-2), 10-17 (2007).
6. Davis RA, Butterfield AM, Konrad RJ, Bourdage JS. A novel method for quantitative measurement of a biomarker in the presence of a therapeutic monoclonal antibody directed against the biomarker. J. Pharm. Biomed. Anal. 48(3), 897-901 (2008).
7. Smith HW, 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. 49(3), 230-237 (2007).
8. Patton A, Mullenix MC, Swanson SJ, Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J. Immunol. Methods 304(1-2), 189-195 (2005).
9. Verch T, Chilewski S, Bouaraphan S et al. Pharmacokinetic immunoassay methods in the presence of soluble target. J. Immunol. Methods 361(1-2), 75-81 (2010).
10. Jayarao KS, Faulk WP, Karam JH, Grodsky GM, Forsham PH. Measurement of immune complexes in insulin-treated diabetics. J. Immunol. Methods 3(4), 337-345 (1973).
11. Davis S, Papadopoulos N, Aldrich TH et al. Angiopoietins have distinct modular domains essential for receptor binding, dimerization and superclustering. Nat. Struct. Biol. 10(1), 38-44 (2003).
12. Ejima D, Tsumoto K, Fukada H et al. Effects of acid exposure on the conformation, stability, and aggregation of monoclonal antibodies. Proteins 66(4), 954-962 (2007).
13. Zhong ZD, Dinnogen S, Hokom M et al. Identification and inhibition of drug target interference in immunogenicity assays. J. Immunol. Methods 355(1-2), 21-28 (2010).
14. Vermeer AW, Norde W. The thermal stability of immunoglobulin: Unfolding and aggregation of a multi-domain protein. Biophys J. 78(1), 394-404 (2000).
15. Myszka DG. Improving biosensor analysis. J. Mol. Recognit. 12(5), 279-284 (1999).
16. Buchner J, Renner M, Lilie H et al. Alternatively folded states of an immunoglobulin. Biochemistry 30(28), 6922-6929 (1991).
17. Uemura Y. Dissociation of aggregated IgG and denaturation of monomeric IgG by acid treatment. Tohoku J. Exp. Med. 141(3), 337-349 (1983).
18. CRC Handbook of Chemistry and Physics. Lide DR (Ed.). Chapman and Hall/CRC Press, FL, USA (1999).
19. Yang J, Quarmby V. Free versus total ligand-binding assays: Points to consider in biotherapeutic drug development. Bioanalysis 3(11), 1163-1165 (2011).