Pre-existing antibody: biotherapeutic modality-based review
Open accessAbstract
Pre-existing antibodies to biotherapeutic drugs have been detected in drug-naïve subjects for a variety of biotherapeutic modalities. Pre-existing antibodies are immunoglobulins that are either specific or cross-reacting with a protein or glycan epitopes on a biotherapeutic compound. Although the exact cause for pre-existing antibodies is often unknown, environmental exposures to non-human proteins, glycans, and structurally similar products are frequently proposed as factors. Clinical consequences of the pre-existing antibodies vary from an adverse effect on patient safety to no impact at all and remain highly dependent on the biotherapeutic drug modality and therapeutic indication. As such, pre-existing antibodies are viewed as an immunogenicity risk factor requiring a careful evaluation. Herein, the relationships between biotherapeutic modalities to the nature, prevalence, and clinical consequences of pre-existing antibodies are reviewed. Initial evidence for pre-existing antibody is often identified during anti-drug antibody (ADA) assay development. Other interfering factors known to cause false ADA positive signal, including circulating multimeric drug target, rheumatoid factors, and heterophilic antibodies, are discussed.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Screening patients for presence of neutralizing antibodies for the gene therapy vector can improve outcomes.
“In the clinical setting, screening patients for presence of neutralizing antibodies for the gene therapy vector can improve outcomes.14,26,142”
From Gene Therapy for Retinal Degenerative Diseases: Progress, Challenges, and Future Directions (2023) · cites this paper as [142]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Manno, C. S., Pierce, G. F., Arruda, V. R., Glader, B., Ragni, M., Rasko, J. J. E., Ozelo, M. C., Hoots, K., Blatt, P., Konkle, B., et al. (2006) · Nature Medicine · doi:10.1038/nm1358 · Cited by 2,163 · see citing works
Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose
Chung, C. H., Mirakhur, B., Chan, E., Le, Q.-T., Berlin, J., Morse, M., Murphy, B. A., Satinover, S. M., Hosen, J., Mauro, D., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa074943 · Cited by 1,521 · see citing works
T and Tn, General Carcinoma Autoantigens
Springer, G. F. (1984) · Science · doi:10.1126/science.6729450 · Cited by 1,009 · see citing works
Worldwide epidemiology of neutralizing antibodies to adeno-associated viruses
Calcedo, R., Vandenberghe, L. H., Gao, G., Lin, J., & Wilson, J. M. (2009) · The Journal of Infectious Diseases · doi:10.1086/595830 · Cited by 808 · see citing works
HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case–cohort analysis
McElrath, M. J., Rosa, S. C. D., Moodie, Z., Dubey, S. A., Kierstead, L. S., Janes, H., Defawe, O., Carter, D. K., Hural, J., Akondy, R. S., et al. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61592-5 · Cited by 712 · see citing works
Armstrong, J. K., Hempel, G., Koling, S., Chan, L. S., Fisher, T., Meiselman, H. J., & Garratty, G. (2007) · Cancer · doi:10.1002/cncr.22739 · Cited by 699 · see citing works
Shankar, G., Devanarayan, V., Amaravadi, L. S., Barrett, Y. C., Bowsher, R. R., Finco‐Kent, D., Fiscella, M., Gorovits, B., Kirschner, S., Moxness, M. S., et al. (2008) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2008.09.020 · Cited by 616 · see citing works
Self-citationHuman Anti-Animal Antibody Interferences in Immunological Assays
Kricka, L. J. (1999) · Clinical Chemistry · doi:10.1093/clinchem/45.7.942 · Cited by 589 · see citing works
Garay, R. P., El-Gewely, R., Armstrong, J. K., Garratty, G., & Richette, P. (2012) · Expert Opinion on Drug Delivery · doi:10.1517/17425247.2012.720969 · Cited by 587 · see citing works
Jaski, B. E., Jessup, M. L., Mancini, D. M., Cappola, T. P., Pauly, D. F., Greenberg, B., Borow, K., Dittrich, H., Zsebo, K. M., & Hajjar, R. J. (2009) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2009.01.013 · Cited by 457 · see citing works
Section XXV Adsorption Chromatographs
Haider, S. I., & Ashtok, A. (2009) · Biotechnology · doi:10.1201/9781420084498-32 · Cited by 453 · see citing works
Antibody-Drug Conjugates for Cancer Therapy
Carter, P. J., & Senter, P. D. (2008) · The Cancer Journal · doi:10.1097/ppo.0b013e318172d704 · Cited by 429 · see citing works
van Ree, R., Cabanes‐Macheteau, M., Akkerdaas, J. H., Milazzo, J.-P., Loutelier‐Bourhis, C., Rayon, C., Villalba, M., Koppelman, S. J., Aalberse, R. C., Rodrı́guez, R., et al. (2000) · Journal of Biological Chemistry · doi:10.1074/jbc.275.15.11451 · Cited by 389 · see citing works
Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins
Ghaderi, D., Taylor, R. E., Padler-Karavani, V., Diaz, S., & Varki, A. (2010) · Nature Biotechnology · doi:10.1038/nbt.1651 · Cited by 372 · see citing works
Pre-existing Anti–Adeno-Associated Virus Antibodies as a Challenge in AAV Gene Therapy
Louis Jeune, V., Joergensen, J. A., Hajjar, R. J., & Weber, T. (2013) · Human Gene Therapy Methods · doi:10.1089/hgtb.2012.243 · Cited by 358 · see citing works
Shankar, G., Arkin, S., Cocea, L., Devanarayan, V., Kirshner, S., Kromminga, A., Quarmby, V. E., Richards, S., Schneider, C. K., Subramanyam, M., et al. (2014) · The AAPS Journal · doi:10.1208/s12248-014-9599-2 · Cited by 354 · see citing works
PEGylated Proteins: Evaluation of Their Safety in the Absence of Definitive Metabolism Studies
Webster, R., Didier, E., Harris, P., Siegel, N., Stadler, J., Tilbury, L., & Smith, D. (2007) · Drug Metabolism and Disposition · doi:10.1124/dmd.106.012419 · Cited by 337 · see citing works
Lipsky, P. E., Calabrese, L. H., Kavanaugh, A., Sundy, J. S., Wright, D. D., Wolfson, M., & Becker, M. A. (2014) · Arthritis Research & Therapy · doi:10.1186/ar4497 · Cited by 266 · see citing works
Hershfield, M. S., Ganson, N. J., Kelly, S. J., Scarlett, E., Jaggers, D. A., & Sundy, J. S. (2014) · Arthritis Research & Therapy · doi:10.1186/ar4500 · Cited by 265 · see citing works
Kang, J. S., DeLuca, P. P., & Lee, K. C. (2009) · Expert Opinion on Emerging Drugs · doi:10.1517/14728210902907847 · Cited by 252 · see citing works
Galili, U., Anaraki, F., Thall, A. D., Hill-Black, C., & Radic, M. Z. (1993) · Blood · doi:10.1182/blood.v82.8.2485.2485 · Cited by 242 · see citing works
Human immunoglobulin allotypes
Jefferis, R., & Lefranc, M. (2009) · mAbs · doi:10.4161/mabs.1.4.9122 · Cited by 237 · see citing works
Antibodies Against Laminaribioside and Chitobioside Are Novel Serologic Markers in Crohn’s Disease
Dotan, I., Fishman, S., Dgani, Y., Schwartz, M., Karban, A. A., Lerner, A., Weisshaus, O., Spector, L., Shtevi, A., Altstock, R. T., et al. (2006) · Gastroenterology · doi:10.1053/j.gastro.2006.04.030 · Cited by 233 · see citing works
Richter, A. W., & Akerblom, E. B. (2009) · International Archives of Allergy and Applied Immunology · doi:10.1159/000233512 · Cited by 229 · see citing works
Messinger, Y. H., Mendelsohn, N. J., Rhead, W. J., Dimmock, D., Hershkovitz, E., Champion, M., Jones, S. A., Olson, R., White, A. L., Wells, C., et al. (2012) · Genetics in Medicine · doi:10.1038/gim.2011.4 · Cited by 214 · see citing works
Wang, L., Calcedo, R., Bell, P., Lin, J., Grant, R. L., Siegel, D. L., & Wilson, J. M. (2011) · Human Gene Therapy · doi:10.1089/hum.2011.031 · Cited by 212 · see citing works
Preclinical safety evaluation of AAV2-sFLT01— a gene therapy for age-related macular degeneration
MacLachlan, T. K., Lukason, M., Collins, M., Munger, R., Isenberger, E., Rogers, C., Malatos, S., DuFresne, E., Morris, J., Calcedo, R., et al. (2011) · Molecular Therapy · doi:10.1038/mt.2010.258 · Cited by 166 · see citing works
Serologic Evidence for Human Infection With Adenovirus-Associated Viruses
Blacklow, N. R., HOGGAN, M. D., & Rowe, W. P. (1968) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/40.2.319 · Cited by 166 · see citing works
Papadopoulos, K. P., ISAACS, R. E., Bilic, S., Kentsch, K., Huet, H. A., Hofmann, M., Rasco, D. W., Kundamal, N., Tang, Z., Cooksey, J., et al. (2015) · Cancer Chemotherapy and Pharmacology · doi:10.1007/s00280-015-2712-0 · Cited by 162 · see citing works
Ten years of Orthoclone OKT3 (muromonab-CD3): a review
Smith, S. L. (1996) · Progress in Transplantation · doi:10.7182/prtr.1.6.3.8145l3u185493182 · Cited by 147 · see citing works
Humanized immunotoxins: A new generation of immunotoxins for targeted cancer therapy
Mathew, M., & Verma, R. S. (2009) · Cancer Science · doi:10.1111/j.1349-7006.2009.01192.x · Cited by 144 · see citing works
Creager, M. A., Olin, J. W., Belch, J. J. F., Moneta, G. L., Henry, T. D., Rajagopalan, S., Annex, B. H., & Hiatt, W. R. (2011) · Circulation · doi:10.1161/circulationaha.110.009407 · Cited by 143 · see citing works
Curtis, B. R., Swyers, J., Divgi, A. B., et al. (2002) · Blood · doi:10.1182/blood.v99.6.2054 · Cited by 131 · see citing works
Pasut, G. (2014) · BioDrugs · doi:10.1007/s40259-013-0064-z · Cited by 126 · see citing works
The long-term international safety experience of imiglucerase therapy for Gaucher disease
Starzyk, K. A., Richards, S. M., Yee, J., Smith, S. E., & Kingma, W. (2006) · Molecular Genetics and Metabolism · doi:10.1016/j.ymgme.2006.09.003 · Cited by 122 · see citing works
Sun, B., Bird, A., Young, S. P., Kishnani, P. S., Chen, Y.-T., & Koeberl, D. D. (2007) · The American Journal of Human Genetics · doi:10.1086/522236 · Cited by 121 · see citing works
A Novel PEGylated Interferon Beta‐1a for Multiple Sclerosis: Safety, Pharmacology, and Biology
Hu, X. S., Miller, L., Richman, S., Hitchman, S., Glick, G., Liu, S., Zhu, Y., Crossman, M., Nestorov, I. A., Gronke, R. S., et al. (2011) · The Journal of Clinical Pharmacology · doi:10.1177/0091270011407068 · Cited by 119 · see citing works
O’Hara, D. M., Theobald, V., Egan, A. C., et al. (2012) · The AAPS Journal · doi:10.1208/s12248-012-9334-9 · Cited by 118 · see citing works
Clinical Experience With Denileukin Diftitox (ONTAK)
Foss, F. M. (2006) · Seminars in Oncology · doi:10.1053/j.seminoncol.2005.12.017 · Cited by 118 · see citing works
van Schie, K. A., Wolbink, G., & Rispens, T. (2015) · mAbs · doi:10.1080/19420862.2015.1048411 · Cited by 117 · see citing works
High-avidity autoantibodies to cytokines
Bendtzen, K., Hansen, M. B., Ross, C., et al. (1998) · Immunology Today · doi:10.1016/s0167-5699(98)01252-3 · Cited by 117 · see citing works
Maiese, W. M., Lechevalier, M. P., Lechevalier, H. A., et al. (1989) · The Journal of Antibiotics · doi:10.7164/antibiotics.42.558 · Cited by 110 · see citing works
Mehvar, R. (2000) · PubMed · Cited by 99 · see citing works
Kakavanos, R., Turner, C. T., Hopwood, J. J., Kakkis, E., & Brooks, D. A. (2003) · The Lancet · doi:10.1016/s0140-6736(03)13311-9 · Cited by 99 · see citing works
Ward, B., Landry, N., Trépanier, S., Mercier, G., Dargis, M., Couture, M., D'Aoust, M.-A., & Vézina, L. (2014) · Vaccine · doi:10.1016/j.vaccine.2014.08.079 · Cited by 98 · see citing works
Liu, Q., Huang, W., Zhang, H., Wang, Y., Zhao, J., Song, A., Xie, H., Zhao, C., Gao, D., & Wang, Y. (2014) · Gene Therapy · doi:10.1038/gt.2014.47 · Cited by 93 · see citing works
Seroepidemiological and Ecological Studies of the Adenovirus-Associated Satellite Viruses
Parks, W. P., Boucher, D. W., Melnick, J. L., Taber, L. H., & Yow, M. D. (1970) · Infection and Immunity · doi:10.1128/iai.2.6.716-722.1970 · Cited by 86 · see citing works
Anticytokine autoantibodies in infectious diseases: pathogenesis and mechanisms
Browne, S., & Holland, S. M. (2010) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(10)70196-1 · Cited by 86 · see citing works
Serum anti-glycan antibodies predict complicated Crohnʼs disease behavior: A cohort study†
Rieder, F., Schleder, S., Wolf, A., Dirmeier, A., Strauch, U., Obermeier, F., Lopez, R., Spector, L., Fire, E., Yarden, J., et al. (2010) · Inflammatory Bowel Diseases · doi:10.1002/ibd.21179 · Cited by 84 · see citing works
How to manage asparaginase hypersensitivity in acute lymphoblastic leukemia
Burke, M. J. (2014) · Future Oncology · doi:10.2217/fon.14.138 · Cited by 84 · see citing works
Holland, M. C., Würthner, J., Morley, P. J., Birchler, M., Lambert, J., Albayaty, M., Serone, A., Wilson, R., Chen, Y., Forrest, R. M., et al. (2013) · Journal of Clinical Immunology · doi:10.1007/s10875-013-9915-0 · Cited by 79 · see citing works
Self-citationAutoantibodies to coagulation factors: From pathophysiology to diagnosis and therapy
Cugno, M., Gualtierotti, R., Tedeschi, A., & Meroni, P. L. (2013) · Autoimmunity Reviews · doi:10.1016/j.autrev.2013.08.001 · Cited by 75 · see citing works
Neutralizing antibodies to interferon β-1a and interferon β-1b in MS patients are cross-reactive
Khan, O., & Dhib-Jalbut, S. S. (1998) · Neurology · doi:10.1212/wnl.51.6.1698 · Cited by 74 · see citing works
Immunogenicity of biological therapeutics
Krieckaert, C. L. M., Rispens, T. T., & Wolbink, G. (2012) · Current Opinion in Rheumatology · doi:10.1097/bor.0b013e3283521c4e · Cited by 72 · see citing works
Bartelds, G. M., de Groot, E. R., Nurmohamed, M. T., Hart, M. H. L., van Eede, P. H., Wijbrandts, C. A., Crusius, J. B. A., Dijkmans, B. A. C., Tak, P. P., Aarden, L. A., et al. (2010) · Arthritis Research & Therapy · doi:10.1186/ar3208 · Cited by 71 · see citing works
Liu, Y., Reidler, H., Pan, J., Milunic, D., Qin, D., Chen, D., Vallejo, R. P., & Yin, R. (2011) · Journal of Pharmacological and Toxicological Methods · doi:10.1016/j.vascn.2011.07.003 · Cited by 64 · see citing works
Xue, L., & Rup, B. J. (2013) · The AAPS Journal · doi:10.1208/s12248-013-9497-z · Cited by 63 · see citing works
Self-citationRheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics
Tatarewicz, S. M., Miller, J. M., Swanson, S. J., & Moxness, M. S. (2010) · Journal of Immunological Methods · doi:10.1016/j.jim.2010.03.012 · Cited by 61 · see citing works
High avidity cytokine autoantibodies in health and disease: Pathogenesis and mechanisms
Watanabe, M., Uchida, K., Nakagaki, K., et al. (2010) · Cytokine & Growth Factor Reviews · doi:10.1016/j.cytogfr.2010.03.003 · Cited by 61 · see citing works
Annoni, A., Cantore, A., Valle, P. D., Goudy, K., Akbarpour, M., Russo, F., Bartolaccini, S., D’Angelo, A., Roncarolo, M. G., & Naldini, L. (2013) · EMBO Molecular Medicine · doi:10.1002/emmm.201302857 · Cited by 59 · see citing works
Brooks, D. A. (1999) · Molecular Genetics and Metabolism · doi:10.1006/mgme.1999.2894 · Cited by 58 · see citing works
Immunogenicity Assays for Antibody–Drug Conjugates: Case Study with Ado-Trastuzumab Emtansine
Carrasco‐Triguero, M., Yi, J., Dere, R. C., Qiu, Z. J., Lei, C., Li, Y., Mahood, C., Wang, B., Leipold, D. D., Poon, K. A., et al. (2013) · Bioanalysis · doi:10.4155/bio.13.64 · Cited by 56 · see citing works
Anti-CD3 Recombinant Diphtheria Immunotoxin Therapy of Cutaneous T Cell Lymphoma
Frankel, A. E., Zuckero, S. L., Mankin, A., Grable, M., Mitchell, K. G., Lee, Y., Neville, D. M., & Woo, J. H. (2009) · Current Drug Targets · doi:10.2174/138945009787354539 · Cited by 50 · see citing works
Warren, D. J., Bjerner, J., Paus, E., et al. (2005) · Clinical Chemistry · doi:10.1373/clinchem.2004.046979 · Cited by 48 · see citing works
Thompson, J., Hu, H., Scharff, J., et al. (1995) · Journal of Biological Chemistry · doi:10.1074/jbc.270.47.28037 · Cited by 47 · see citing works
Steenholdt, C., Palarasah, Y., Bendtzen, K., et al. (2013) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.12330 · Cited by 47 · see citing works
Rapid development of genotypic resistance to lamivudine when combined with zidovudine in pregnancy
Clarke, J. R., Braganza, R., Mirza, A., Stainsby, C. M., Ait‐Khaled, M., Wright, A., Lyall, H., Parker, D., McClure, M. O., Weber, J. N., et al. (1999) · Journal of Medical Virology · doi:10.1002/(sici)1096-9071(199911)59:3 · Cited by 44 · see citing works
Review: Neutralizing antibodies against interferon-beta
Sørensen, P. S. (2008) · Therapeutic Advances in Neurological Disorders · doi:10.1177/1756285608095144 · Cited by 43 · see citing works
Coagulation Factor IX for Hemophilia B Therapy
Orlova, N. A., Kovnir, S. V., Vorobiev, I. I., & Габибов, А. Г. (2012) · Acta Naturae · doi:10.32607/20758251-2012-4-2-62-73 · Cited by 43 · see citing works
Xue, L., Fiscella, M., Rajadhyaksha, M., et al. (2013) · The AAPS Journal · doi:10.1208/s12248-013-9492-4 · Cited by 39 · see citing works
Self-citationTillmann, H. L., Ganson, N. J., Patel, K., Thompson, A. J., Abdelmalek, M. F., Moody, T., McHutchison, J. G., & Hershfield, M. S. (2010) · Journal of Hepatology · doi:10.1016/s0168-8278(10)60309-1 · Cited by 37 · see citing works
Ballard, J. L., Weaver, F. A., Singla, N., et al. (2009) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2009.09.042 · Cited by 35 · see citing works
Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose
Arnold, D., & Misbah, S. (2008) · New England Journal of Medicine · doi:10.1056/nejmc080834 · Cited by 35 · see citing works
Carrasco‐Triguero, M., Mahood, C., Milojic-Blair, M., et al. (2012) · Bioanalysis · doi:10.4155/bio.12.165 · Cited by 34 · see citing works
Myler, H. A., Hruska, M. W., Srinivasan, S., Cooney, E. L., Kong, G., Dodge, R. W., Krishna, M., Zhu, J., Felix, T., Gleason, C. R., et al. (2015) · Bioanalysis · doi:10.4155/bio.15.36 · Cited by 34 · see citing works
Self-citationInterleukin‐1–inhibitory IgG in sera from some patients with rheumatoid arthritis
Suzuki, H., Akama, T., Okane, M., et al. (1989) · Arthritis & Rheumatism · doi:10.1002/anr.1780321206 · Cited by 33 · see citing works
Chen, K., Page, J. G., Schwartz, A. M., Lee, T. N., DeWall, S. L., Sikkema, D. J., & Wang, C. (2013) · Journal of Immunological Methods · doi:10.1016/j.jim.2013.04.011 · Cited by 33 · see citing works
Protein-Based Matrix Interferences in Ligand-Binding Assays
Gorovits, B., McNally, J., Krinos‐Fiorotti, C., & Leung, S. S. (2014) · Bioanalysis · doi:10.4155/bio.14.56 · Cited by 32 · see citing works
Self-citationAraujo, J., Zocher, M., Wallace, K., et al. (2011) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2011.03.008 · Cited by 30 · see citing works
Silent hypersensitivity toEscherichia coliasparaginase in children with acute lymphoblastic leukemia
Strullu, M., Corradini, N., AUDRAIN, M. A. P., Orsonneau, J., Bouige, D., Thomaré, P., Vermot‐Desroches, C., Mansuy, A., Legrand, A., Rozé, J., et al. (2010) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.3109/10428194.2010.494316 · Cited by 30 · see citing works
Human heterophilic antibodies display specificity for murine IgG subclasses
Bjerner, J., Olsen, K. H., Børmer, O. P., et al. (2005) · Clinical Biochemistry · doi:10.1016/j.clinbiochem.2005.02.008 · Cited by 30 · see citing works
The Origins, Specificity, and Potential Biological Relevance of Human Anti-IgG Hinge Autoantibodies
Brezski, R. J., Knight, D. M., & Jordan, R. E. (2011) · The Scientific World JOURNAL · doi:10.1100/tsw.2011.107 · Cited by 29 · see citing works
Immune response to enzyme replacement therapy in Fabry disease: Impact on clinical outcome?
Hollak, C. E. M., & Linthorst, G. E. (2008) · Molecular Genetics and Metabolism · doi:10.1016/j.ymgme.2008.10.013 · Cited by 28 · see citing works
Pediatric Constipation Therapy Using Guidelines and Polyethylene Glycol 3350
Bell, E. A., & Wall, G. C. (2004) · Annals of Pharmacotherapy · doi:10.1345/aph.1d297 · Cited by 26 · see citing works
Miller, L. L., Korn, E. L., Stevens, D., et al. (1999) · Blood · doi:10.1182/blood.v93.10.3250.410k35_3250_3258 · Cited by 24 · see citing works
Mandy, W. J. (1967) · PubMed · Cited by 22 · see citing works
Tatarewicz, S. M., Juan, G., Swanson, S. J., et al. (2012) · Journal of Immunological Methods · doi:10.1016/j.jim.2012.05.009 · Cited by 20 · see citing works
Matsuo, T., Suzuki, S., Matsuo, M., et al. (2005) · Pathophysiology of Haemostasis and Thrombosis · doi:10.1159/000088543 · Cited by 20 · see citing works
Switching clotting factor concentrates: considerations in estimating the risk of immunogenicity
Matino, D., Lillicrap, D., Astermark, J., Dolan, G., Kessler, C. M., Lambert, T., Makris, M., O’Donnell, J. S., Pipe, S. W., Santagostino, E., et al. (2013) · Haemophilia · doi:10.1111/hae.12283 · Cited by 20 · see citing works
Cousens, L. P., Mingozzi, F., van der Marel, S., Su, Y. A., Garman, R. D., Ferreira, V., Martin, W. D., Scott, D. W., & Groot, A. S. D. (2012) · Human Vaccines & Immunotherapeutics · doi:10.4161/hv.21405 · Cited by 18 · see citing works
Sauerborn, M., & Schellekens, H. (2009) · Current Opinion in Biotechnology · doi:10.1016/j.copbio.2009.10.007 · Cited by 16 · see citing works
Matar, A. J., Pathiraja, V., Wang, Z., et al. (2012) · Transplant Immunology · doi:10.1016/j.trim.2012.05.003 · Cited by 14 · see citing works
Impact of Matrix-Associated Soluble Factors on The Specificity of The Immunogenicity Assessment
Bautista, A., Wullner, D., Moxness, M., et al. (2010) · Bioanalysis · doi:10.4155/bio.10.24 · Cited by 14 · see citing works
A New Serum Factor in Normal Rabbits
Mandy, W. J. (1967) · The Journal of Immunology · doi:10.4049/jimmunol.99.4.815 · Cited by 14 · see citing works
Soos, J. M., Polsky, R., Keegan, S., et al. (2003) · Clinical Immunology · doi:10.1016/s1521-6616(03)00180-3 · Cited by 13 · see citing works
Li, X., Johnson, R., & Gorovits, B. (2009) · The AAPS Journal · doi:10.1208/s12248-009-9165-5 · Cited by 11 · see citing works
Self-citationMyler, H. A., Felix, T., Zhu, J., et al. (2014) · Bioanalysis · doi:10.4155/bio.14.37 · Cited by 8 · see citing works
Self-citationGlaros, E. N., Turner, C. T., Parkinson-Lawrence, E. J., et al. (2002) · Molecular Genetics and Metabolism · doi:10.1016/s1096-7192(02)00148-8 · Cited by 7 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- Erles K, Sebokova P, Schlehofer JR. Update on the prevalence of serum antibodies (IgG and IgM) to adeno-associated virus (AAV). J Med Virol. 1999;59(3):406-11.
Cited by
Sorted by citations
Hoang Thi, T. T., Pilkington, E. H., Nguyen, D. H., Lee, J. S., Park, K. D., & Truong, N. P. (2020) · Polymers · doi:10.3390/polym12020298 · Cited by 668 · see citing works
Gene Therapy for Retinal Degenerative Diseases: Progress, Challenges, and Future Directions
Drag, S., Dotiwala, F., & Upadhyay, A. K. (2023) · Investigative Opthalmology & Visual Science · doi:10.1167/iovs.64.7.39 · Cited by 145 · see citing works
Nakagawa, H., Iizuka, H., Nemoto, O., Shimabe, M., Furukawa, Y., Kikuta, N., & Ootaki, K. (2020) · Journal of Dermatological Science · doi:10.1016/j.jdermsci.2020.06.005 · Cited by 66 · see citing works
- Authors
- Gorovits, B., Clements-Egan, A., Birchler, M., Liang, M., Myler, H., Peng, K., Purushothama, S., Rajadhyaksha, M., Salazar-Fontana, L., Sung, C., & Xue, L.
- Affiliations
- Pfizer (United States) (US)
- GlaxoSmithKline (United States) (US)
- Bristol-Myers Squibb (United States) (US)
- Genentech (US)
- UCB Pharma (United Kingdom) (GB)
- Regeneron (United States) (US)
- Sanofi (United States) (US)
- Corresponding author
- Gorovits, Boris
- Venue
- The AAPS Journal
- Published
- 2016-01-28
- Volume
- 18
- Issue
- 2
- Pages
- 311-320
- ISSN
- 1550-7416 (ISSN-L)
- PMC
- PMC4779092
- OpenAlex
- W2288666258
- Cited by
- 85
- References
- 98
- Citations by year
- 2026: 5 · 2025: 14 · 2024: 5 · 2023: 9 · 2022: 6 · 2021: 6 · 2020: 5 · 2019: 13 · 2018: 11 · 2017: 6 · 2016: 5
- FWCI
- 1.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- The AAPS Journal (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Genentech
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Keywords
- pre-existing antibodies, biologic therapy, anti-drug antibodies, immunogenicity, cross-reactive antibodies, carbohydrate epitopes, rheumatoid factor, heterophile antibodies, patient safety
- MeSH terms
- Animals, Antibodies, Monoclonal, Autoantibodies, Biological Products, Biological Therapy, Humans
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
