Preclinical immunogenicity testing for recombinant therapeutic proteins

Journal of Immunotoxicology

Volumn 2, Issue 4, 2005, Pages 203-210

  Smith, Holly W ^a   Wierda, Daniel ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Immunoassay; Immunogenicity; Predictive; Protein; Sensitivity

Indexed keywords

ALTEPLASE; HUMAN GROWTH HORMONE; IMMUNOGLOBULIN G4; INSULIN DERIVATIVE; INSULIN LISPRO; MONOCLONAL ANTIBODY; PARATHYROID HORMONE; RECOMBINANT HUMAN INSULIN; RECOMBINANT LEPTIN; RECOMBINANT PARATHYROID HORMONE; RECOMBINANT PROTEIN;

ANALYTIC METHOD; ARTICLE; ASSAY; CAPILLARY ELECTROPHORESIS; CLINICAL TRIAL; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IMMUNE RESPONSE; IMMUNIZATION; IMMUNOASSAY; IMMUNOGENICITY; LIQUID; MEDICAL RESEARCH; NONHUMAN; PRIORITY JOURNAL; SENSITIVITY ANALYSIS; SOLID; SURFACE PLASMON RESONANCE;

ANIMALIA;

EID: 29044437057     PISSN: 16602854     EISSN: 1547691X     Source Type: Journal    
DOI: 10.1080/15476910500362911     Document Type: Article

References (13)

1. Eli Lilly and Company. 2004a. HUMALOG Lispro Injection (rDNA Origin). Prescribing Information #PA 9129 FSAMP. Eli Lilly and Company, Indianapolis, IN.
2. Eli Lilly and Company. 2004b. FORTEO teriparatide (rDNA Origin) injection. Prescribing Information #PA 9242 FSAMP. Eli Lilly and Company, Indianapolis, IN.
3. Eli Lilly and Company. 2005. HUMATROPE Somatropin (rDNA Origin) for Injection Vials and Cartridges. Prescribing Information #PA 1644 AMP. Eli Lilly and Company, Indianapolis, IN.
4. Fineberg, S. E., Huang, I., Brunelle, R., Gulliya, K. S., and Anderson, J. H. 2003. Effect of long-term exposure to insulin LisPro on the induction of antibody response in patients with Type 1 or Type 2 diabetes. Diabetes Care 26:89-96.
5. International Committee for Harmonization. 1997. Guidance for Industry. S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Available at 〈http://www.fda.gov/cder/guidance/1859fnl.pdf〉.
6. Mire-Sluis, A. R., Barrett, Y. C., Devanaraayan, V., Koren E., Liu, H., Maia, M., Parish, T., Scott, G., Shankar, G., Shores, E., Swanson, S. J., Taniguchi, G., Wierda, D., and Zuckerman, L. A. 2004. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Meth. 289:1-16.
7. Otteson, J. L., Nilsson, P., Jami, J., Weilguny, D., Duhrkop, M., Bucchini, D., Havelund, S., and Fogh, J. M. 1994. The potential immunogenicity of human insulin and insulin analogues evaluated in a transgenic mouse model. Diabetalogia 37:1178-1185.
8. Stewart, T. A., Hollingshead, P. G., Pitts, S. L., Chang, R., Martin, L. E., and Oakley, H. 1989. Transgenic mice as a model to test immunogenicity of proteins altered by site-specific mutagenesis. Mol. Biol. Med. 6:275-281.
9. U.S. Department of Health and Human Services Food and Drug Administration, Center for Biologies Evaluation and Research. 1997. Points to Consider in the Manufacturing and Testing of Monoclonal Antibody Products for Human Use. #94D-0259. Available at 〈http://www.fda.gov/cber/guidelines. htm〉.
10. Wild, D., Ed. 2001. The Immunoassay Handbook. New York: Nature Publishing Group.
11. Zwickl, C. M., Cocke, K. S., Tamura, R. N., Holzhausen, L. M., Brophy, G. T. Bick, P. H., and Wierda, D. 1991. Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys. Fundam. Appl. Toxicol. 16:275-287.
12. Zwickl, C. M., Hughes, B. L., Piroozi, K. S., Smith, H. W., and Wierda, D. 1996. Immunogenicity of tissue plasminogen activators in rhesus monkeys: Antibody formation and effects on blood level and enzymatic activity. Fundam. Appl. Toxicol. 30:243-254.
13. Zwickl, C. M., Smith, H. W., Zimmerman, J. L., and Wierda, D. 1995. Immunogenicity of biosynthetic human LysPro insulin compared to native-sequence human and purified porcine insulins in rhesus monkeys immunized over a 6-week period. Arz. Forsch./Drug Res. 45:524-528.