Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters

Drug Discovery Today

Volumn 16, Issue 7-8, 2011, Pages 345-353

  Barbosa, Maria D F S ^a  

^a CA Consultants   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA INTERFERON; BETA1A INTERFERON; BETASERUM; BIOBETTER; BIOSIMILAR; BLOOD CLOTTING FACTOR 8; HYBRID PROTEIN; INTERFERON BETA SERINE; MAJOR HISTOCOMPATIBILITY ANTIGEN CLASS 2; NATURAL PRODUCT; RECOMBINANT BETA INTERFERON; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; VACCINE;

COMPUTER MODEL; COST BENEFIT ANALYSIS; DRUG APPROVAL; EUROPE; HLA SYSTEM; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; OUTCOME ASSESSMENT; PATIENT SAFETY; PRACTICE GUIDELINE; REVIEW; UNITED STATES;

ANIMALS; ANTIBODY FORMATION; BIOLOGICAL PRODUCTS; DRUG DESIGN; HUMANS; MICE; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79953681018     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2011.01.011     Document Type: Review

References (75)

1. A.B. Engelberg Balancing innovation, access, and profits - market exclusivity for biologics N. Engl. J. Med. 361 2009 1917 1919
2. D.E. Wheadon Market exclusivity for biologics N. Engl. J. Med. 362 2010 661 662 author reply
3. A. Pollock, and M. Zagari Market exclusivity for biologics N. Engl. J. Med. 362 2010 661 662 author reply
4. A.S. Rosenberg Immunogenicity of biological therapeutics: a hierarchy of concerns Dev. Biol. 112 2003 15 21
5. R. Ponce Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies Regul. Toxicol. Pharmacol. 54 2009 164 182
6. J. Woodcock The FDA's assessment of follow-on protein products: a historical perspective Nat. Rev. Drug Discov. 6 2007 437 442 (Pubitemid 47078655)
7. M.D. Barbosa, and E. Celis Immunogenicity of protein therapeutics and the interplay between tolerance and antibody responses Drug Discov. Today 12 2007 674 681 (Pubitemid 47238643)
8. M. Sauerborn Immunological mechanism underlying the immune response to recombinant human protein therapeutics Trends Pharmacol. Sci. 31 2010 53 59
9. A.S. Rosenberg Effects of protein aggregates: an immunologic perspective AAPS J. 8 2006 E501 507
10. H. Schellekens The first biosimilar epoetin: but how similar is it? Clin. J. Am. Soc. Nephrol. 3 2008 174 178
11. H. Schellekens, and E. Moors Clinical comparability and European biosimilar regulations Nat. Biotechnol. 28 2010 28 31
12. D.A. Hughes Biosimilars: evidential standards for health technology assessment Clin. Pharmacol. Ther. 87 2010 257 261
13. E.M. Antman Treatment of 150 cases of life-threatening digitalis intoxication with digoxin-specific fab antibody fragments Circulation 81 1990 1744 1752 (Pubitemid 20183822)
14. J. Korner, and L.J. Aronne Pharmacological approaches to weight reduction: therapeutic targets J. Clin. Endocrinol. Metab. 89 2004 2616 2621 (Pubitemid 38766340)
15. E. Koren Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products J. Immunol. Methods 333 2008 1 9
16. H. Schellekens Assessing the bioequivalence of biosimilars. The Retacrit case Drug Discov. Today 14 2009 495 499
17. T.T. Hansel The safety and side effects of monoclonal antibodies Nat. Rev. Drug Discov. 9 2010 325 338
18. A.R. Mire-Sluis Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products J. Immunol. Methods 289 2004 1 16 (Pubitemid 38900899)
19. S. Gupta Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics J. Immunol. Methods 321 2007 1 18 (Pubitemid 46454303)
20. G. Shankar Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products J. Pharm. Biomed. Anal. 48 2008 1267 1281
21. G. Ritter Serological analysis of human anti-human antibody responses in colon cancer patients treated with repeated doses of humanized monoclonal antibody A33 Cancer Res. 61 2001 6851 6859 (Pubitemid 32896510)
22. J.A. Lofgren Comparing ELISA and surface plasmon resonance for assessing clinical immunogenicity of panitumumab J. Immunol. 178 2007 7467 7472 (Pubitemid 46847475)
23. D. Sickert Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore J. Immunol. Methods 334 2008 29 36
24. J. Li Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet((R)) biolayer interferometry J. Pharm. Biomed. Anal. 54 2011 286 294
25. R.L. Rich Biosensor-based fragment screening using FastStep injections Anal. Biochem. 407 2010 270 277
26. A. Patton An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen J. Immunol. Methods 304 2005 189 195 (Pubitemid 41262233)
27. J.A. Lofgren Detection of neutralizing anti-therapeutic protein antibodies in serum or plasma samples containing high levels of the therapeutic protein J. Immunol. Methods 308 2006 101 108 (Pubitemid 43107958)
28. H. Neubert Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry Anal. Chem. 80 2008 6907 6914
29. H.W. Smith Detection of antibodies against therapeutic proteins in the presence of residual therapeutic protein using a solid-phase extraction with acid dissociation (SPEAD) sample treatment prior to ELISA Regul. Toxicol. Pharmacol. 49 2007 230 237 (Pubitemid 350087397)
30. J.S. Bourdage An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug J. Immunol. Methods 327 2007 10 17 (Pubitemid 47444307)
31. N. Savoie 2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance Bioanalysis 2 2010 1945 1960
32. M. Clark Antibody humanization: a case of the 'Emperor's new clothes'? Immunol. Today 21 2000 397 402 (Pubitemid 30612301)
33. A.J. Chirino, and A. Mire-Sluis Characterizing biological products and assessing comparability following manufacturing changes Nat. Biotechnol. 22 2004 1383 1391 (Pubitemid 39482857)
34. A.J. Chirino, and A.R. Mire-Sluis State of the art analytical comparability: a review Dev. Biol. 122 2005 3 26 (Pubitemid 43002206)
35. J.P. Gabrielson, and K.K. Arthur Measuring low levels of protein aggregation by sedimentation velocity Methods 2010 10.1016/j.ymeth.2010.12.030
36. V. Brinks Quality of original and biosimilar Epoetin products Pharm. Res. 2010 10.1007/s11095-010-0288-2
37. A. Beck Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins Curr. Pharm. Biotechnol. 9 2008 482 501
38. J.G. Barnard Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway J. Pharm. Sci. 100 2010 492 503
39. S.K. Singh An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics J. Pharm. Sci. 99 2010 3302 3321
40. S.J. Israels, and E.D. Israels Development of antibodies to bovine and human factor V in two children after exposure to topical bovine thrombin Am. J. Pediatr. Hematol. Oncol. 16 1994 249 254 (Pubitemid 24223776)
41. D.G. Neschis Coagulopathy as a result of factor V inhibitor after exposure to bovine topical thrombin J. Vasc. Surg. 35 2002 400 402 (Pubitemid 44718652)
42. M. Ratner Recombinant thrombin approved Nat. Biotechnol. 26 2008 250
43. J.L. Ballard Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin J. Am. Coll. Surg. 210 2010 199 204
44. C.H. Chung Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose N. Engl. J. Med. 358 2008 1109 1117 (Pubitemid 351398485)
45. M.M. van Beers Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance by human interferon beta J. Immunol. Methods 352 2010 32 37
46. V.S. Purohit Influence of aggregation on immunogenicity of recombinant human Factor VIII in hemophilia A mice J. Pharm. Sci. 95 2006 358 371 (Pubitemid 43241978)
47. S. Hermeling Development of a transgenic mouse model immune tolerant for human interferon Beta Pharm. Res. 22 2005 847 851 (Pubitemid 40898093)
48. M.M. van Beers Aggregated recombinant human interferon Beta induces antibodies but no memory in immune-tolerant transgenic mice Pharm. Res. 27 2010 1812 1824
49. A.H. Fradkin Immunogenicity of aggregates of recombinant human growth hormone in mouse models J. Pharm. Sci. 98 2009 3247 3264
50. K. Wing CTLA-4 control over Foxp3+ regulatory T cell function Science 322 2008 271 275
51. N. Jain Dual function of CTLA-4 in regulatory T cells and conventional T cells to prevent multiorgan autoimmunity Proc. Natl. Acad. Sci. U. S. A. 107 2010 1524 1528
52. A.S. De Groot Activation of natural regulatory T cells by IgG Fc-derived peptide 'Tregitopes' Blood 112 2008 3303 3311
53. L.E. Lippert Relationship of major histocompatibility complex class II genes to inhibitor antibody formation in hemophilia A Thromb. Haemost. 64 1990 564 568
54. D. Frommel HLA antigens and factor VIII antibody in classic hemophilia European Study group of factor VIII antibody Thromb. Haemost. 46 1981 687 689 (Pubitemid 12198337)
55. W.R. Mayr HLA-DR and Factor VIII antibodies in hemophilia A Thromb. Haemost. 51 1984 293 (Pubitemid 14145116)
56. A.M. Aly Histocompatibility antigen patterns in haemophilic patients with factor VIII antibodies Br. J. Haematol. 76 1990 238 241
57. J.J. Kapur Association between HLA-DQB1*0602 allele and antibodies to factor VIII in hemophilia A Hum. Immunol. 40 1994 96
58. C.R. Hay HLA class II profile: a weak determinant of factor VIII inhibitor development in severe haemophilia A. UKHCDO Inhibitor Working Party Thromb. Haemost. 77 1997 234 237 (Pubitemid 27084906)
59. J. Oldenburg HLA genotype of patients with severe haemophilia A due to intron 22 inversion with and without inhibitors of factor VIII Thromb. Haemost. 77 1997 238 242 (Pubitemid 27084907)
60. M. Jacquemin CD4+ T-cell clones specific for wild-type factor VIII: a molecular mechanism responsible for a higher incidence of inhibitor formation in mild/moderate hemophilia A Blood 101 2003 1351 1358 (Pubitemid 36182506)
61. J. Astermark Polymorphisms in the IL10 but not in the IL1beta and IL4 genes are associated with inhibitor development in patients with hemophilia A Blood 107 2006 3167 3172
62. A. Pavlova Impact of polymorphisms of the major histocompatibility complex class II, interleukin-10, tumor necrosis factor-alpha and cytotoxic T-lymphocyte antigen-4 genes on inhibitor development in severe hemophilia A J. Thromb. Haemost. 7 2009 2006 2015
63. G.L. Bray Loss of high-responder inhibitors in patients with severe hemophilia A and human immunodeficiency virus type 1 infection: a report from the Multi-Center Hemophilia Cohort Study Am. J. Hematol. 42 1993 375 379 (Pubitemid 23104809)
64. M.D. Barbosa Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity Clin. Immunol. 118 2006 42 50 (Pubitemid 43012045)
65. S. Hoffmann HLA-DRB1*0401 and HLA-DRB1*0408 are strongly associated with the development of antibodies against interferon-beta therapy in multiple sclerosis Am. J. Hum. Genet. 83 2008 219 227
66. K. Praditpornsilpa The association of anti-r-HuEpo-associated pure red cell aplasia with HLA-DRB1*09-DQB1*0309 Nephrol. Dial. Transplant. 24 2009 1545 1549
67. T.A. Rohn A novel strategy for the discovery of MHC class II-restricted tumor antigens: identification of a melanotransferrin helper T-cell epitope Cancer Res. 65 2005 10068 10078 (Pubitemid 41541489)
68. M. Stickler The HLA-DR2 haplotype is associated with an increased proliferative response to the immunodominant CD4(+) T-cell epitope in human interferon-beta Genes Immun. 5 2004 1 7 (Pubitemid 38967623)
69. R. Mueller Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout J. Pharm. Sci. 98 2009 3548 3561
70. A.S. De Groot Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates Curr. Opin. Pharmacol. 8 2008 620 626
71. A. Jaber, and M. Baker Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T-cell assays J. Pharm. Biomed. Anal. 43 2007 1256 1261
72. A. Jaber The Rebif new formulation story: it's not trials and error Drugs R. D. 8 2007 335 348 (Pubitemid 350014786)
73. S. Tangri Rationally engineered therapeutic proteins with reduced immunogenicity J. Immunol. 174 2005 3187 3196 (Pubitemid 40354020)
74. E. Koren Clinical validation of the 'in silico' prediction of immunogenicity of a human recombinant therapeutic protein Clin. Immunol. 124 2007 26 32 (Pubitemid 46938690)
75. D. Wullner Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics Clin. Immunol. 137 2010 5 14