Evaluation of an immunoassay for human-specific quantitation of therapeutic antibodies in serum samples from non-human primates

Journal of Pharmaceutical and Biomedical Analysis

Volumn 49, Issue 4, 2009, Pages 1003-1008

  Stubenrauch, Kay ^a   Wessels, Uwe ^a   Lenz, Helmut ^a  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

Author keywords

Cross reactivity; Immunoassay; Specificity; Therapeutic antibody

Indexed keywords

ANTIBODY; HUMAN FC GAMMA PAN:R10Z8E9 ANTIBODY; IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY; POLYCLONAL ANTIBODY; SOMATOMEDIN C RECEPTOR ANTIBODY; UNCLASSIFIED DRUG;

ACCURACY; ANIMAL EXPERIMENT; ANIMAL TISSUE; ANTIBODY DETECTION; ANTIBODY SPECIFICITY; ARTICLE; BABOON; CHIMPANZEE; CONTROLLED STUDY; CROSS REACTION; DISSOCIATION CONSTANT; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; MALE; MARMOSET; NONHUMAN; PRIMATE; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RHESUS MONKEY; SERUM; SINGLE DRUG DOSE; SPECIES DIFFERENCE; STANDARD; SURFACE PLASMON RESONANCE; VALIDATION PROCESS;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODY SPECIFICITY; CALIBRATION; CROSS REACTIONS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOASSAY; IMMUNOGLOBULIN FC FRAGMENTS; IMMUNOGLOBULIN G; MACACA FASCICULARIS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS;

EID: 62749198591     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.01.030     Document Type: Article

References (11)

1. Reichert J.M., and Valge-Archer V.E. Nat. Rev. Drug Discov. 6 (2007) 349-356
2. Mahmood I., and Green M.D. Clin. Pharmacokinet. 44 (2005) 331-347
3. Lonberg N. Handb. Exp. Pharmacol. 181 (2008) 69-97
4. Newman R., Alberts I., Anderson D., Carner K., Heard C., Norton F., Raab R., Reff M., Shuey S., and Hanna N. Biotechnology 10 (1992) 1455-1460
5. Lewis A.P., Barber K.A., Cooper H.J., Sims M.J., Worden J., and Crowe J.S. Dev. Comp. Immunol. 17 (1993) 549-560
6. D'Ovidio M.C., Pace M., Via F., Strom P., and Turillazzi P.G. Folia Primatol. (Basel) 63 (1994) 221-225
7. Vugmeyster Y., Szklut P., Tchistiakova L., Abraham W., Kasaian M., and Xu X. Int. Immunopharmacol. 8 (2008) 477-483
8. Kelley S.K., Gelzleichter T., Xie D., Lee W.P., Darbonne W.C., Qureshi F., Kissler K., Oflazoglu E., and Grewal I.S. Br. J. Pharmacol. 148 (2006) 1116-1123
9. Yang J., Ng C., Lowman H., Chestnut R., Schofield C., Sandlund B., Ernst J., Bennett G., and Quarmby V. J. Immunol. Methods 335 (2008) 8-20
10. Lund J., Takahashi N., Pound J.D., Goodall M., and Jefferis R. J. Immunol. 157 (1996) 4963-4969
11. Guidance for Industry, Bioanalytical Method Validation, May 2001. http://www.fda.gov/cder/guidance/4252fnl.pdf.