Validation of the BIACORE 3000 platform for detection of antibodies against erythropoietic agents in human serum samples

Current Medical Research and Opinion

Volumn 19, Issue 7, 2003, Pages 651-659

  Mason, Stephanie ^a   La, Stephon ^a   Mytych, Daniel ^a   Swanson, Steven J ^a   Ferbas, John ^a  

^a AMGEN INC   (United States)

Author keywords

Biosensing techniques; Darbepoetin alfa; Enzyme linked immunosorbent immunoassay; Epoetin alfa; Immunoassay; Surface plasmon resonance; Validation studies

Indexed keywords

IMMUNOGLOBULIN G ANTIBODY; NEUTRALIZING ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; ANTIBODY DETECTION; ARTICLE; BIOSENSOR; CONTROLLED STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHROCYTE APLASIA; HUMAN; IMMUNOASSAY; NONHUMAN; RABBIT; SERUM;

ANIMALS; ANTIBODIES; ERYTHROPOIETIN; HUMANS; IMMUNOASSAY; RABBITS; SENSITIVITY AND SPECIFICITY;

EID: 0142122415     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079903125002414     Document Type: Article

References (16)

1. Porter S. Human immune response to recombinant human proteins. J Pharm Sci 2001;90:1-11
2. Koren E. From characterization of antibodies to prediction of immunogenicity. Dev Biol 2002;109:87-95
3. 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 2002;346:469-75
4. Swanson SJ, Mytych D, Ferbas J. Use of biosensors to monitor the immune response. Devel Biol 2002;109:71-8
5. Swanson SJ. New technologies for the detection of antibodies to therapeutic proteins. Dev Biol 2003;112:127-33
6. Findlay JWA, Smith WC, Lee JW, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal 2000;21:1249-73
7. Jönsson U, Fägerstam LG, Ivarsson B, et al. Real-time biospecific interaction analysis using surface plasmon resonance and a sensor chip technology. Biotechniques 1991;11:620-7
8. Van Regenmortel MH. Use of biosensors to characterize recombinant proteins. Dev Biol Standards 1994;83:143-51
9. Malmqvist M, Karlsson R. Biomolecular interaction analysis: affinity biosensor technologies for functional analysis of proteins. Curr Opin Chem Biol 1997;1:378-83
10. Schuck P. Use of surface plasmon resonance to probe the equilibrium and dynamic aspects of interactions between biological macromolecules. Annu Rev Biophys Biomol Struct 1997;26:541-66
11. Pearson JE, Kane JW, Petraki-Kallioti I, Gill A, Vadgama P. Surface plasmon resonance: a study of the effect of biotinylation on the selection of antibodies for use in immunoassays. J Immunol Methods 1998;221:87-94
12. Fägerstam LG, Frostell A, Karlsson R, et al. Detection of antigen-antibody interactions by surface plasmon resonance. Application to epitope mapping. J Mol Recognit 1990;3:208-14
13. Ohlson S, Strandh M, Nilshans S. Detection and characterization of weak affinity antibody-antigen recognition with biomolecular interaction analysis. J Mol Recognit 1997;10:135-8
14. Van Regenmortel MH, Altschuh D, Chatellier L, et al. Measurements of antigen-antibody interactions with biosensors. J Mol Recognit 1998;11:163-7
15. Huber A, Demartis S, Neri D. The use of biosensor technology for the engineering of antibodies and enzymes. J Mol Recognit 1999;12:198-216
16. Wong R, Mytych D, Jacobs S, Borden R, Swanson SJ. Validation parameters for a novel biosensor assay which simultaneously measures serum concentrations of a humanized monoclonal antibody and detects induced antibodies. J Immunol Methods 1997;209:1-15