Validation parameters for a novel biosensor assay which simultaneously measures serum concentrations of a humanized monoclonal antibody and detects induced antibodies

Journal of Immunological Methods

Volumn 209, Issue 1, 1997, Pages 1-15

  Wong, Robbie L ^a   Mytych, Daniel ^a   Jacobs, Sheila ^a   Bordens, Ronald ^a   Swanson, Steven J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Biosensor assays; Humanized monoclonal antibody; Validation

Indexed keywords

HUMAN MONOCLONAL ANTIBODY;

ANTIBODY DETECTION; ANTIGEN ANTIBODY REACTION; ARTICLE; AUTOMATION; BIOSENSOR; HUMAN; IMMOBILIZATION; IMMUNOASSAY; NONHUMAN; PRIORITY JOURNAL; VALIDATION PROCESS;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOSENSING TECHNIQUES; HUMANS; INTERLEUKIN-5; LIGANDS; LINEAR MODELS; MICE; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 0031563954     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0022-1759(97)00140-3     Document Type: Article

References (12)

1. Fägerstam L.G., Frostell Å., Karlsson R., Kullman M., Larson A., Malmqvist M., Butt H. Detection of antigen-antibody interactions by surface plasmon resonance. Application to epitope mapping. J. Mol. Recog. 3:1991;208-214.
2. Johanson K., Appelbaum E., Doyal M., Hensley P.et al. Binding interactions of human interleukin 5 with its α-receptor subunit. J. Biol. Chem. 270(16):1995;9459-9471.
3. Jönsson, U., 1992. Real Time BIA. A New Biosensor Based Technology for the Direct Measurement of Biomolecular Interactions. Biosensors: Fundamentals, Technologies and Applications. VCH, pp. 467-476.
4. Jönsson U., Fagerstam L., Ivarsson B., Johnsson B., Karlsson R.et al. Real-time biospecific interaction analysis using surface plasmon resonance and a sensor chip technology. BioTechniques. 11(5):1991;620-627.
5. Knower T., Carlson J., Yarmush D.M., Yarmush M.L., Granzow R. The characterization of antibody-antigen interactions by a novel sensor technology: BIACORE™ Biophys. J. 59:1991;170a.
6. Löfås, S., Johnsson, B., 1990. A novel hydrogel matrix on gold surfaces in surface plasmon resonance sensors for fast and efficient covalent immobilization of ligands. J. Chem. Soc. Chem. Commun. 1526-1528.
7. Malmqvist M. Biospecific interaction analysis using biosensor technology. Nature. 361:1993;186-187.
8. Mayo C.S., Hallock R.B. Immunoassay based on surface plasmon oscillations. J. Immunol. Methods. 120:1989;105-114.
9. Milburn M.V., Hassell A.M., Lambert M.H., Jordan S.R., Proudfoot A.E., Graber P., Wells T.N. A novel dimer configuration revealed by the crystal structure at 2.4 Å resolution of human interleukin-5. Nature. 363:1993;172-176.
10. Morton T.A., Bennett D.B., Appelbaum E.R., Cusimano D.M., Johanson K.O., Matico R.E., Young P.R., Doyle M., Chaiken I.M. Analysis of the interaction between human interleukin-5 and the soluble domain of its receptor using surface plasmon resonance biosensor. J. Mol. Recog. 6:1994;1-9.
11. Raether, H., 1977. In: Hass, G. (Ed.), Surface Plasmon Oscillations and Their Applications in Physics of Thin Films, vol. 9. Academic Press, New York, p. 145.
12. Shah V.P., Midah K.K., Dighe S.et al. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. J. Pharm. Sci. 81(3):1992;309-312.