Literature DB >> 30599169

Immunogenicity of Protein Pharmaceuticals.

Robert Dingman1, Sathy V Balu-Iyer2.   

Abstract

Protein therapeutics have drastically changed the landscape of treatment for many diseases by providing a regimen that is highly specific and lacks many off-target toxicities. The clinical utility of many therapeutic proteins has been undermined by the potential development of unwanted immune responses against the protein, limiting their efficacy and negatively impacting its safety profile. This review attempts to provide an overview of immunogenicity of therapeutic proteins, including immune mechanisms and factors influencing immunogenicity, impact of immunogenicity, preclinical screening methods, and strategies to mitigate immunogenicity.
Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  antibody(s); immune response(s); immunogenicity; immunology; pharmacodynamics; pharmacokinetics; protein(s)

Mesh：

Substances：

Year:  2018        PMID： 30599169      PMCID： PMC6720129          DOI： 10.1016/j.xphs.2018.12.014

Source DB:  PubMed          Journal:  J Pharm Sci        ISSN： 0022-3549            Impact factor:   3.534


  234 in total

Review 1.  Divided we stand: tracking cell proliferation with carboxyfluorescein diacetate succinimidyl ester.

Authors:  A B Lyons
Journal:  Immunol Cell Biol       Date:  1999-12       Impact factor: 5.126

2.  Epitope mapping of human anti-adeno-associated virus type 2 neutralizing antibodies: implications for gene therapy and virus structure.

Authors:  M Moskalenko; L Chen; M van Roey; B A Donahue; R O Snyder; J G McArthur; S D Patel
Journal:  J Virol       Date:  2000-02       Impact factor: 5.103

Review 3.  The impact of the non-classical MHC proteins HLA-DM and HLA-DO on loading of MHC class II molecules.

Authors:  H Kropshofer; G J Hämmerling; A B Vogt
Journal:  Immunol Rev       Date:  1999-12       Impact factor: 12.988

4.  Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group.

Authors:  C G Groth; L Bäckman; J M Morales; R Calne; H Kreis; P Lang; J L Touraine; K Claesson; J M Campistol; D Durand; L Wramner; C Brattström; B Charpentier
Journal:  Transplantation       Date:  1999-04-15       Impact factor: 4.939

5.  Epitope mapping of immunogenic and adhesive structures in repetitive domains of Mycoplasma bovis variable surface lipoproteins.

Authors:  K Sachse; J H Helbig; I Lysnyansky; C Grajetzki; W Müller; E Jacobs; D Yogev
Journal:  Infect Immun       Date:  2000-02       Impact factor: 3.441

6.  Correction of the coagulation defect in hemophilia A mice through factor VIII expression in skin.

Authors:  S S Fakharzadeh; Y Zhang; R Sarkar; H H Kazazian
Journal:  Blood       Date:  2000-05-01       Impact factor: 22.113

7.  Carboxyfluorescein succinimidyl ester-based proliferative assays for assessment of T cell function in the diagnostic laboratory.

Authors:  D Fulcher; S Wong
Journal:  Immunol Cell Biol       Date:  1999-12       Impact factor: 5.126

8.  Characterization of a major neutralizing epitope on human papillomavirus type 16 L1.

Authors:  W I White; S D Wilson; F J Palmer-Hill; R M Woods; S J Ghim; L A Hewitt; D M Goldman; S J Burke; A B Jenson; S Koenig; J A Suzich
Journal:  J Virol       Date:  1999-06       Impact factor: 5.103

9.  Structure of small virus-like particles assembled from the L1 protein of human papillomavirus 16.

Authors:  X S Chen; R L Garcea; I Goldberg; G Casini; S C Harrison
Journal:  Mol Cell       Date:  2000-03       Impact factor: 17.970

10.  Comparison of biological activity and safety of recombinant canine erythropoietin with that of recombinant human erythropoietin in clinically normal dogs.

Authors:  J F Randolph; T Stokol; J M Scarlett; J N MacLeod
Journal:  Am J Vet Res       Date:  1999-05       Impact factor: 1.156
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  18 in total

1.  Covalent Labeling/Mass Spectrometry of Monoclonal Antibodies with Diethylpyrocarbonate: Reaction Kinetics for Ensuring Protein Structural Integrity.

Authors:  Patanachai K Limpikirati; Bo Zhao; Xiao Pan; Stephen J Eyles; Richard W Vachet
Journal:  J Am Soc Mass Spectrom       Date:  2020-04-30       Impact factor: 3.109

2.  A humanized minipig model for the toxicological testing of therapeutic recombinant antibodies.

Authors:  Tatiana Flisikowska; Jerome Egli; Angelika Schnieke; Antonio Iglesias; Krzysztof Flisikowski; Marlene Stumbaum; Erich Küng; Martin Ebeling; Roland Schmucki; Guy Georges; Thomas Singer; Mayuko Kurome; Barbara Kessler; Valeri Zakhartchenko; Eckhard Wolf; Felix Weber
Journal:  Nat Biomed Eng       Date:  2022-09-22       Impact factor: 29.234

3.  Immunogenicity risk assessment for biotherapeutics through in vitro detection of CD134 and CD137 on T helper cells.

Authors:  Sivan Cohen; Srividya Myneni; Anna Batt; Joyce Guerrero; Jochen Brumm; Shan Chung
Journal:  MAbs       Date:  2021 Jan-Dec       Impact factor: 5.857

4.  De novo design of functional zwitterionic biomimetic material for immunomodulation.

Authors:  Bowen Li; Zhefan Yuan; Priyesh Jain; Hsiang-Chieh Hung; Yuwei He; Xiaojie Lin; Patrick McMullen; Shaoyi Jiang
Journal:  Sci Adv       Date:  2020-05-29       Impact factor: 14.136

Review 5.  Immunogenicity of Bioproducts: Cellular Models to Evaluate the Impact of Therapeutic Antibody Aggregates.

Authors:  Myriam Nabhan; Marc Pallardy; Isabelle Turbica
Journal:  Front Immunol       Date:  2020-05-05       Impact factor: 7.561

6.  Investigation of monoclonal antibody dimers in a final formulated drug by separation techniques coupled to native mass spectrometry.

Authors:  G Rouby; N T Tran; Y Leblanc; M Taverna; N Bihoreau
Journal:  MAbs       Date:  2020 Jan-Dec       Impact factor: 5.857

7.  Trastuzumab immunogenicity development in patients' sera and in laboratory animals.

Authors:  Lobna Abdel Aziz Kilany; Ayman Abdel Samie Gaber; Mohammad Mabrouk Aboulwafa; Hamdallah Hafez Zedan
Journal:  BMC Immunol       Date:  2021-02-19       Impact factor: 3.615

8.  An integrated approach for characterizing immunogenic responses toward a bispecific antibody.

Authors:  Sivan Cohen; Shan Chung; Christoph Spiess; Victor Lundin; Eric Stefanich; Steven T Laing; Vanessa Clark; Jochen Brumm; Ying Zhou; Catherine Huang; Joyce Guerrero; Srividya Myneni; Rajbharan Yadav; Ketevan Siradze; Kun Peng
Journal:  MAbs       Date:  2021 Jan-Dec       Impact factor: 5.857

Review 9.  The Emerging Jamboree of Transformative Therapies for Autoimmune Diseases.

Authors:  José M Carballido; Camille Regairaz; Celine Rauld; Layla Raad; Damien Picard; Michael Kammüller
Journal:  Front Immunol       Date:  2020-03-31       Impact factor: 7.561

10.  Population Pharmacokinetics and Pharmacodynamics of Burosumab in Adult and Pediatric Patients With X-linked Hypophosphatemia.

Authors:  Sun Ku Lee; Nathalie H Gosselin; Julie Taylor; Mary Scott Roberts; Kathleen McKeever; Jack Shi
Journal:  J Clin Pharmacol       Date:  2021-08-27       Impact factor: 2.860
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