Immunogenicity/Hypersensitivity of biologics

Toxicologic Pathology

Volumn 42, Issue 1, 2014, Pages 293-300

  Leach, Michael W ^a   Rottman, James B ^b   Hock, M Benjamin ^b   Finco, Deborah ^a   Rojko, Jennifer L ^c   Beyer, Joseph C ^d  

^a PFIZER INC   (United States)

^b AMGEN INC   (United States)

^c CHARLES RIVER LABORATORIES   (United States)

^d GENENTECH INC   (United States)

Author keywords

antidrug antibodies; biologics; complement; drug development; electron microscopy; hypersensitivity; immunogenicity; immunohistochemistry.

Indexed keywords

ANTIBODY; ANTIGEN; BIOLOGICAL PRODUCT; COMPLEMENT; COMPLEMENT COMPONENT C3B RECEPTOR; IMMUNOGLOBULIN E;

ALLERGIC REACTION; ANAPHYLAXIS; ANTIGEN ANTIBODY COMPLEX; ARTICLE; CADAVER; ELECTRON MICROSCOPY; ERYTHROCYTE; IMMUNE RESPONSE; IMMUNOGENICITY; MAST CELL; NONHUMAN; PRIORITY JOURNAL;

ANTIDRUG ANTIBODIES; BIOLOGICS; COMPLEMENT; DRUG DEVELOPMENT; ELECTRON MICROSCOPY; HYPERSENSITIVITY; IMMUNOGENICITY; IMMUNOHISTOCHEMISTRY.;

ANIMALS; ANTIBODIES; BIOLOGICAL PRODUCTS; DRUG HYPERSENSITIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; IMMUNOGLOBULIN E;

EID: 84892751074     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623313510987     Document Type: Article

References (39)

1. AltmanL. K. (1982). A new insulin given approval for use in U.S. New York Times, October 30. Accessed September 26, 2013. http://www.nytimes.com/1982/10/ 30/us/a-new-insulin-given-approval-for-use-in-us.html.
2. Barger T. E., Kuck A. J., Chirmule N., Swanson S. J., Mytych D. T. Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: An immunoassay platform comparison. Nephrol Dial Transplant. 2012 ; 27: 688-93
3. Bautista A. C., Salimi-Moosavi H., Jawa V. Universal immunoassay applied during early development of large molecules to understand impact of immunogenicity on biotherapeutic exposure. AAPS J. 2012 ; 14: 843-9
4. Bergseth G., Ludviksen J. K., Kirschfink M., Giclas P. C., Nilsson B., Mollnes T. E. An international serum standard for application in assays to detect human complement activation products. Mol Immunol. 2013 ; 56: 232-9
5. Birmingham D. J., Hebert L. A. CR1 and CR1-like: The primate immune adherence receptors. Immunol Rev. 2001 ; 180: 100-11
6. Bugelski P. J., Treacy G. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. Curr Opin Mol Ther. 2004 ; 6: 10-16
7. Bulek A. M., Cole D. K., Skowera A., Dolton G., Gras S., Madura F., Fuller A., Miles J. J., Gostick E., Price D. A., Drijfhout J. W., Knight R. R., Huang G. C., Lissin N., Molloy P. E., Wooldridge L., Jakobsen B. K., Rossjohn J., Peakman M., Rizkallah P. J., Sewell A. K. Structural basis for the killing of human beta cells by CD8(+) T cells in type 1 diabetes. Nature Imm. 2012 ; 13: 283-89
8. Civoli F., Kroenke M. A., Reynhardt K., Zhuang Y., Kaliyaperumal A., Gupta S. Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity. Bioanalysis. 2012 ; 4: 2725-35
9. Clark D., Shiota F., Forte C., Narayanan P., Mytych D. T., Hock M. B. Biomarkers for non-human primate type-I hypersensitivity: Antigen-specific immunoglobulin E assays. J Immunol Methods. 2013 ; 392: 29-37
10. Cosio F. G., Shen X. P., Birmingham D. J., Van Aman M., Hebert L. A. Evaluation of the mechanisms responsible for the reduction in erythrocyte complement receptors when immune complexes form in vivo in primates. J Immunol. 1990 ; 145: 4198-206
11. De Groot A. S., Martin W. Reducing risk, improving outcomes: bioengineering less immunogenic protein therapeutics. Clin Immunol. 2009 ; 131: 189-201
12. Devanarayan V., Tovey M. G Detection and Quantification of Antibodies to Biopharmaceuticals. Tovey M.G., ed. Hoboken, NJ: John Wiley & Sons ; 2011: pp.
13. Edberg J. C., Tosic L., Taylor R. P. Immune adherence and the processing of soluble complement-fixing antibody/DNA immune complexes in mice. Clin Immunol Immunopathol. 1989 ; 51: 118-32
14. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. 2007 :
15. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (Draft). 2009 :
16. DRAFT - Guidance for industry, immunogenicity assessment for therapeutic protein products. Biotechnol Law Rep. 2013 ; 32: 172-85
17. Finco-Kent D., Grenham A Detection and Quantification of Antibodies to Biopharmaceuticals. Tovey M. G., ed. Hoboken, NJ: John Wiley & Sons ; 2011: 243-268.
18. Gruchalla R. S. 10. Drug allergy. J Allergy Clin Immunol. 2003 ; 111 (2 Suppl). S548-59
19. Hebert L. A. The clearance of immune complexes from the circulation of man and other primates. Am J Kidney Dis. 1991 ; 17: 352-61
20. S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. 2011 :
21. Jiang H., Chess L. How the immune system achieves self-nonself discrimination during adaptive immunity. Adv Immunol. 2009 ; 102: 95-133
22. Jönsson F., Mancardi D. A., Kita Y., Karasuyama H., Iannascoli B., Van Rooijen N., Shimizu T., Daëron M., Bruhns P. Mouse and human neutrophils induce anaphylaxis. J Clin Invest. 2011 ; 121: 1484-96
23. Jönsson F., Mancardi D. A., Zhao W., Kita Y., Iannascoli B., Khun H., van Rooijen N., Shimizu T., Schwartz L. B., Daëron M., Bruhns P. Human FcγRIIA induces anaphylactic and allergic reactions. Blood. 2012 ; 119: 2533-44
24. Junod S. W. Celebrating a Milestone: FDA's approval of first genetically-engineered product. Update Magazine. 2007 ;:
25. Koren E., De Groot A. S., Jawa V., Beck K. D., Boone T., Rivera D., Li L., Mytych D., Koscec M., Weeraratne D., Swanson S., Martin W. Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein. Clin Immunol. 2007 ; 124: 26-32
26. Leach M. W. Differences between protein-based biologic products (biotherapeutics) and chemical entities (small molecules) of relevance to the toxicologic pathologist. Toxicol Pathol. 2013 ; 41: 128-36
27. Naisbitt D. J., Williams D. P., Pirmohamed M., Kitteringham N. R., Park B. K. Reactive metabolites and their role in drug reactions. Curr Opin Allergy Immunol. 2001 ; 1: 317-25
28. Pichler W. J Drug Hypersensitivity. Pichler W. J., ed. Karger: Basel ; 2007: 168-89.
29. Ponce R., Abad L., Amaravadi L., Gelzleichter T., Gore E., Green J., Gupta S., Herzyk D., Hurst C., Ivens I. A., Kawabata T., Maier C., Mounho B., Rup B., Shankar G., Smith H., Thomas P., Wierda D. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies. Regul Toxicol Pharmacol. 2009 ; 54: 164-82
30. Quigg R. J., Holers V. M. Characterization of rat complement receptors and regulatory proteins. CR2 and Crry are conserved, and the C3b receptor of neutrophils and platelets is distinct from CR1. J Immunol. 1995 ; 155: 1481-8
31. Riedl M. A., Casillas A. M. Adverse drug reactions: Types and treatment options. Am Fam Physician. 2003 ; 68: 1781-90
32. Shankar G., Devanarayan V., Amaravadi L., Barrett Y. C., Bowsher R., Finco-Kent D., Fiscella M., Gorovits B., Kirschner S., Moxness M., Parish T., Quarmby V., Smith H., Smith W., Zuckerman L. A., Koren E. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008 ; 48: 1267-81
33. Stubenrauch K., Wessels U., Essig U., Vogel R., Schleypen J. Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies. J Pharm Biomed Anal. 2010 ; 52: 249-54
34. Swanson S. J., Bussiere J. Immunogenicity assessment in non-clinical studies. Curr Opin Microbiol. 2012 ; 15: 337-47
35. Taylor L. US pharma: 907 biologic drugs and vaccines now in R&D. PharmaTimes. 2013 ;:
36. Ugurlucan M., Caglar I. M., Caglar F. N., Ziyade S., Karatepe O., Yildiz Y., Zencirci E., Ugurlucan F. G., Arslan A. H., Korkmaz S., Filizcan U., Cicek S. Aspirin: From a historical perspective. Recent Pat Cardiovasc Drug Discov. 2012 ; 7: 71-6
37. Verdier F., Patriarca C., Descotes J. Autoantibodies in conventional toxicity testing. Toxicology. 1997 ; 119: 51-58
38. Wakshull E., Hendricks R., Amaya C., Coleman D. Proposal for a new protein therapeutic immunogenicity titer assay cutpoint. Bioanalysis. 2011 ; 3: 2627-36
39. Wu B. W., Gunn G. R., Shankar G Detection and Quantification of Antibodies to Biopharmaceuticals. Tovey M. G., ed. Hoboken, NJ: John Wiley & Sons ; 2011: 175-92.