Comparison of assay formats for drug-tolerant immunogenicity testing

Bioanalysis

Volumn 2, Issue 12, 2010, Pages 1961-1969

  Butterfield, Anthony M ^a   Chain, Jana S ^a   Ackermann, Bradley L ^a   Konrad, Robert J ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; FC FUSION PROTEIN; HYBRID PROTEIN; MONOCLONAL ANTIBODY; PEGYLATED PROTEIN; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; DIAGNOSTIC AGENT; DRUG; PROTEIN;

ACID DISSOCIATION; AFFINITY CAPTURE ELUTION; ANALYTICAL PARAMETERS; ARTICLE; ASSAY; CONTROLLED STUDY; DRUG DETERMINATION; DRUG SAFETY; DRUG TOLERANCE; HAPLORHINI; HOOK EFFECT; HUMAN; IMMUNOGENICITY; INTERMETHOD COMPARISON; MESO SCALE DISCOVERY BRIDGING; NONHUMAN; RISK ASSESSMENT; SOLID PHASE EXTRACTION; BIOASSAY; COMPARATIVE STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; EVALUATION; IMMUNOLOGY; METABOLISM; METHODOLOGY; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY;

ANTIBODIES, MONOCLONAL; BIOLOGICAL ASSAY; DRUG TOLERANCE; ENZYME-LINKED IMMUNOSORBENT ASSAY; PHARMACEUTICAL PREPARATIONS; PROTEINS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION;

EID: 79952466635     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.136     Document Type: Article

References (15)

1. Mire-Sluis AR, Barrett YC, Devanarayan V et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289, 1-16 (2004). (Pubitemid 38900899)
2. Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An affnity 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, 10-17 (2007). (Pubitemid 47444307)
3. Moxness M, Tatarewicz S, Weeraratne D et al. Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies. Clin. Chem. 51, 1983-1985 (2005). (Pubitemid 41368199)
4. Smith HW, Butterfeld 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, 230-237 (2007). (Pubitemid 350087397)
5. US FDA. Draft Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), MD USA (2009).
6. Koren E, Zuckerman LA, Mire-Sluis AR. Immune response to therapeutic proteins in humans-clinical signifcance, assessment and prediction. Curr. Pharm. Biotechnol. 3, 349-360 (2002). (Pubitemid 35364009)
7. Casadevall N, Nataf J, Viron B et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin N. Engl. J. Med. 346, 469-475 (2002). (Pubitemid 34441737)
8. Baert F, Norman M, Vermeire S et al. Infuence of immunogenicity on the long-term effcacy of infiximab in Crohn's disease. N. Engl. J. Med. 348, 2155-2156 (2003). (Pubitemid 36583318)
9. 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, 189-195 (2005). (Pubitemid 41262233)
10. Quinn TC, Kline R, Moss MW, Livingston RA, Hutton N. Acid dissociation of immune complexes improves diagnostic utility of p24 antigen detection in perinatally acquired human immunodefciency virus infection. J. Infect. Dis. 167, 1193-1196 (1993). (Pubitemid 23115614)
11. Jayarao KS, Faulk WP, Karam JH, Grodsky GM, Forsham PH. Measurement of immune complexes in insulin-treated diabetics. J. Immunol. Methods 3, 337-345 (1973).
12. Roch AM, Delcros JG, Ripoll JP, Thomas V, Richard J, Quash G. A novel covalent enzyme-linked immunoassay (CELIA) for simultaneously measuring free and immune complex-bound antibodies of defned specifcity: I. Application to naturally occurring antipolyamine antibodies in human sera. J. Immunol. Methods 4, 1-11 (1990). (Pubitemid 20334478)
13. Quingyou L, Chuanhai C, Chackerian B et al. Overcoming antigen masking of anti-amyloid-ß antibodies reveal breaking of B cell tolerance by virus-like particles in amyloid-ß immunized amyloid precursor protein transgenic mice. BMC Neurosci. 5, 21-27 (2004).
14. Diamondis E, Christopoulos TK. The biotin-(strept)avidin system: principles and applications in biotechnology. Clin. Chem. 37, 625-632 (1991).
15. Liang M, Klakamp SL, Funelas C et al. Detection of high-and low-affnity antibodies against a human monoclonal antibody using various technology platforms. Assay Drug Dev. Technol. 5, 655-662 (2007).