Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

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Items 101–200 of 250

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2. Antibody-Based Inhibition of Pathogenic New World Hemorrhagic Fever Mammarenaviruses by Steric Occlusion of the Human Transferrin Receptor 1 Apical Domain
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4. Porous reduced graphene oxide modified electrodes for the analysis of protein aggregation. Part 1: Lysozyme aggregation at pH 2 and 7.4
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5. Advances in epidermal growth factor receptor specific immunotherapy: lessons to be learned from armed antibodies
   Fleury Augustin Nsole Biteghe, Neelakshi Mungra, Nyangone Ekome Toung Chalomie, Jean De La Croix Ndong, Jean Engohang‐Ndong, Guillaume Vignaux, Eden Rebecca Padayachee, Krupa Naran, Stefan Barth · 2020 · Oncotarget
6. Improving the In Vivo Efficacy of an Anti-Tac (CD25) Immunotoxin by Pseudomonas Exotoxin A Domain II Engineering
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7. Biomarkers for nonclinical infusion reactions in marketed biotherapeutics and considerations for study design
   Kirsten M. Mease, Amy L. Kimzey, Janice A. Lansita · 2017 · Current Opinion in Toxicology
8. Intracellular distribution of TM4SF1 and internalization of TM4SF1-antibody complex in vascular endothelial cells
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9. Recent advances in nanoscale materials for antibody-based cancer theranostics
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10. Maturity-related Variability of the Thymus in Cynomolgus Monkeys ( Macaca fascicularis )
    Paul W. Snyder, Nancy E. Everds, W. A. Craven, Jonathan A. Werner, Sarah H. Tannehill‐Gregg, Roberto E. Guzman · 2016 · Toxicologic Pathology
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12. The Role of Anti-Drug Antibodies in the Pharmacokinetics, Disposition, Target Engagement, and Efficacy of a GITR Agonist Monoclonal Antibody in Mice
    N. D. Brunn, Smita Mauze, Danling Gu, Derek Wiswell, Roanna Ueda, Douglas Hodges, Amy M. Beebe, Shuli Zhang, Enrique Escandón · 2015 · Journal of Pharmacology and Experimental Therapeutics
13. Functionally Active Fc Mutant Antibodies Recognizing Cancer Antigens Generated Rapidly at High Yields
    Kristina M. Ilieva, Judit Fazekas, Daniela Achkova, Tihomir S. Dodev, Silvia Mele, Silvia Crescioli, Heather J. Bax, Anthony Cheung, Panagiotis Karagiannis, Isabel Corrêa et al. · 2017 · Frontiers in Immunology
14. Cancer Immunotherapy: Factors Important for the Evaluation of Safety in Nonclinical Studies
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15. Conditionally Active, pH-Sensitive Immunoregulatory Antibodies Targeting VISTA and CTLA-4 Lead an Emerging Class of Cancer Therapeutics
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16. Investigative safety strategies to improve success in drug development
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17. Why Animal Studies are Still Being Used in Drug Development
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18. Better safe than sorry: dual targeting antibodies for cancer immunotherapy
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19. Tri-specific killer engager: unleashing multi-synergic power against cancer
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20. Immunological potential of cytotoxic T lymphocyte antigen 4 immunoglobulin in murine autoimmune cholangitis
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21. Addressing the Immunogenicity of the Cargo and of the Targeting Antibodies with a Focus on Deimmunized Bacterial Toxins and on Antibody-Targeted Human Effector Proteins
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22. Development of capillary size exclusion chromatography for the analysis of monoclonal antibody fragments extracted from human vitreous humor
    Jennifer C. Rea, Yun Lou, Joel Cuzzi, Yuhua Hu, Isabella de Jong, Yajun Jennifer Wang, Dell Farnan · 2012 · Journal of Chromatography A
23. Automated flow fluorescent noncompetitive immunoassay for measurement of human plasma levels of monoclonal antibodies used for immunotherapy of cancers with KinExA™ 3200 biosensor
    Haitham K. Alrabiah, Mohammed Abbas Ali Hamidaddin, Ibrahim A. Darwısh · 2018 · Talanta
24. Immune System
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25. Rethinking the necessity of long-term toxicity studies for biotherapeutics using weight of evidence assessment
    Payal Rana, Brett D. Hollingshead, Raja S. Mangipudy · 2024 · Regulatory Toxicology and Pharmacology
26. Manumycin A downregulates release of proinflammatory cytokines from TNF alpha stimulated human monocytes
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27. Anti-drug antibodies to LMB-100 are enhanced by mAbs targeting OX40 and CTLA4 but not by mAbs targeting PD1 or PDL-1
    Ronit Mazor, Emily M. King, Ira H Pastan · 2018 · Cellular Immunology
28. Exploiting mAb structure characteristics for a directed QbD implementation in early process development
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29. Therapeutic monoclonal antibodies with a focus on hereditary angioedema
    Bruce L. Zuraw, Marcus Maurer, Daniel J. Sexton, Marco Cicardi · 2022 · Allergology International
30. Immunotherapy of prostate cancer: identification of new treatments and targets for therapy, and role of WAP domain-containing proteins
    Christine Galustian, Annapurna Vyakarnam, Oussama Elhage, Oliver J. Hickman, Prokar Dasgupta A, Richard A. Smith · 2011 · Biochemical Society Transactions
31. Therapeutic Monoclonal Antibodies for Metabolic Disorders: Major Advancements and Future Perspectives
    Pratiksha Jamadade, Neh Nupur, Krushna Ch Maharana, Sanjiv Singh · 2024 · Current Atherosclerosis Reports
32. Advancements in Immunotherapy for Breast Cancer: Mechanisms, Efficacy, and Future Directions
    Archita Rai, Swati G Deshpande, Ashish Vaidya, Raju Kamlakar Shinde · 2024 · Cureus
33. Measuring T-cell responses against LCV and CMV in cynomolgus macaques using ELISPOT: Potential application to non-clinical testing of immunomodulatory therapeutics
    Cris Kamperschroer, Lynn M. O’Donnell, Patricia A. Schneider, Dingzhou Li, Marc D. Roy, Timothy Coskran, Thomas T. Kawabata · 2013 · Journal of Immunotoxicology
34. Utility of High Resolution 2D NMR Fingerprinting in Assessing Viscosity of Therapeutic Monoclonal Antibodies
    Subhabrata Majumder, Deep S. Bhattacharya, Alex Langford, Arun Alphonse Ignatius · 2022 · Pharmaceutical Research
35. Development of a flowchart for risk assessment and allocation of preparation of monoclonal antibodies
    Tiene G. M. Bauters, Johan Vandenbroucke · 2017 · Journal of Oncology Pharmacy Practice
36. Occupational Exposure Risks When Working with Protein Therapeutics and the Development of a Biologics Banding System
    Jessica C. Graham, Hugh Yao, Elise Franklin · 2021 · Applied Biosafety
37. Lost in Translation ( LiT ): IUPHAR Review 6
    Colin T. Dollery · 2014 · British Journal of Pharmacology
38. Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing
    Peter C. Ulrich, Guenter Blaich, Andreas Baumann, Rajni Fagg, Adam Hey, Andrea Kießling, Sven Kronenberg, Rikke Hvid Lindecrona, Silke Mohl, W. Richter et al. · 2018 · Regulatory Toxicology and Pharmacology
39. Recombinant cucurmosin-based immunotoxin targeting HER-2 with potent in vitro anti-cancer cytotoxicity
    Jiani Xiong, Caiyun Zhang, Shuifa Wu, Xiaofan Gu, Yu-Mei Cai, Chunseng Xu, Zhou Chen, Jiancheng Sun, Xiangxin Wu, Xiuhua You et al. · 2019 · Biochemical and Biophysical Research Communications
40. The application of human tissue for drug discovery and development
    Margaret Clotworthy · 2012 · Expert Opinion on Drug Discovery
41. Structure−Activity Relationships of New 1‐Aryl‐1H‐Indole Derivatives as SARS‐CoV‐2 Nsp13 Inhibitors
    Valentina Noemi Madia, Roberta Emmolo, Elisa Patacchini, Donatella Amatore, Stefania Maloccu, Davide Ialongo, Aurora Albano, Giuseppe Ruggieri, Emanuele Cara, Laura Zarbo et al. · 2025 · ChemMedChem
42. Extracellular domain of human 4-1BBL enhanced the function of cytotoxic T-lymphocyte induced by dendritic cell
    Chenxuan Wu, Hongxing Guo, Yijun Wang, Yingtang Gao, Zhengyan Zhu, Du Zhi · 2011 · Cellular Immunology
43. A Novel Highly Sensitive Chemiluminescence Enzyme Immunoassay with Signal Enhancement Using Horseradish Peroxidase-Luminol-Hydrogen Peroxide Reaction for the Quantitation of Monoclonal Antibodies Used for Cancer Immunotherapy
    Ibrahim A. Darwısh, Nourah Z. Alzoman, Nehal N. Khalil · 2023 · Chemosensors
44. Optimization of experimental conditions for functional in vitro characterization of humanized antibodies specific for staphylococcal enterotoxin B
    Jennifer MacIntyre, Avanish Kumar Varshney, Xiaobo Wang, Scott Gatto, Clarence Friedman, Yan Liu, Kelvin M. Kerns, Oleg Kovalenko, Karissa Adkins, Richard S. Zollner et al. · 2015 · International Immunopharmacology
45. Clinical Immunotoxicology
    L. Peyton Myers · 2018 · Methods in molecular biology
46. Mechanism-Driven Design of Multispecific Antibodies for Targeted Disease Treatment
    Justyn Fine, Bunyarit Meksiriporn, Jiacheng Tan, Jamie B. Spangler · 2024 · Annual Review of Chemical and Biomolecular Engineering
47. Targeting Aging Hallmarks with Monoclonal Antibodies: A New Era in Cancer Immunotherapy and Geriatric Medicine
    Michele Dal Bo, Marta Gambirasi, Idris Vruzhaj, Erika Cecchin, Abbas Pishdadian, Giuseppe Toffoli, Amin Safa · 2025 · International Journal of Molecular Sciences
48. Is an in vitro whole blood cytokine assay useful to detect the potential risk of severe infusion reaction of monoclonal antibody pharmaceuticals?
    Yoshika Iwata, Asako Harada, Toshiko Hara, Chiyomi Kubo, Tomoaki Inoue, Mitsuyasu Tabo, Corinne C. Ploix, Tobias Manigold, Heather J. Hinton, Masayuki Mishima · 2016 · The Journal of Toxicological Sciences
49. Consequences and Indicators of Test Article-Related Immune Suppression in Nonhuman Primates
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50. Regulatory Forum Commentary*
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51. Effects of subchronic exposure of nonylphenol on the expression of immune-related factors and estrogen receptors in the spleen of rats
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52. Translational Safety Genetics
    Priyasma Bhoumik, Alberto Del Río-Espínola, Florian Hahne, Jonathan G. Moggs, Olivier Grenet · 2016 · Toxicologic Pathology
53. Synthetic Antibody Mimics Based on Cancer‐Targeting Immunostimulatory Peptides
    Dante B. Descalzi‐Montoya, Rachel A. Montel, Keith Smith, Eugenia Dziopa, Andrieh Darwich, Zheng Rong Yang, Constantine Bitsaktsis, Robert Korngold, David Sabatino · 2020 · ChemBioChem
54. Screening of Phytoconstituents from Traditional Plants against SARSCoV- 2 using Molecular Docking Approach
    Deepika Saini, Kumud Madan, Shilpi Chauhan · 2022 · Letters in Drug Design & Discovery
55. Multidisciplinary approaches to combat emerging viruses: diagnostics, therapeutic gene and vaccine delivery, and nanotherapeutics
    Xianqiang Yu, Qing He, Qingming Kong · 2024 · Frontiers in Microbiology
56. Development and validation of generic heterogeneous fluoroimmunoassay for bioanalysis of bevacizumab and cetuximab monoclonal antibodies used for cancer immunotherapy
    Mohammed Abbas Ali Hamidaddin, Haitham K. Alrabiah, Ibrahim A. Darwısh · 2018 · Talanta
57. Development of a BiTE®-mediated CD8+cytotoxic T-lymphocyte activity assay to assess immunomodulatory potential of drug candidates inCynomolgusmacaque
    Brendon T. Frank, Yu-Ling Wei, Kyung-Hoon Kim, Abraham Guerrero, Herve N. Lebrec, Mercedesz Balázs, Xiaoting Wang · 2018 · Journal of Immunotoxicology
58. Biologic Immunomodulatory Drugs and Infection in the Respiratory Tract of Nonhuman Primates
    Thierry Flandre, Alessandro Piaia, Maurice G. Cary · 2020 · Toxicologic Pathology
59. Immunogenicity of Therapeutic Proteins: A Regulatory Perspective
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60. Species Selection for Pharmaceutical Toxicity Studies
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61. Monoclonal Antibodies: An Emerging Class of Therapeutics in Non Small Cell Lung Cancer
    Laurent Guilleminault, É. Lemarié, Nathalie Heuzé‐Vourc'h · 2012 · Journal of Cancer Therapy
62. Biopharmaceuticals
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63. Highly sensitive in vitro cytokine release assay incorporating high-density preculture
    Shiho Ito, Kyoko Miwa, Chiharu Hattori, Tetsuo Aida, Yoshimi Tsuchiya, Kazuhiko Mori · 2021 · Journal of Immunotoxicology
64. Preclinical Development of Monoclonal Antibodies
    Kathleen B. Meyer-Tamaki · 2012 · Elsevier eBooks
65. Monoclonal Antibodies
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66. Immunotoxicology
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67. Conditionally Activatable Antibody Platforms: Mechanisms, Modalities, and Clinical Translation Potential
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68. A senescent tumor cell-derived nanovesicle directly primes splenic T cells to potentiate cancer radiotherapy
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69. An ELISA for detection of complement-bound circulating immune complexes in mice
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70. Murinization and H Chain Isotype Matching of the Anti-GITR Antibody DTA-1 Reduces Immunogenicity-Mediated Anaphylaxis in C57BL/6 Mice
    Nicole A. Belmar, Sarah W Chan, Melvin Fox, Josue A. Samayoa, Marcia M Stickler, Ninian Tran, Yoshiko Akamatsu, Diane L. Hollenbaugh, Fiona Harding, Hamsell M. Alvarez · 2017 · The Journal of Immunology
71. Preclinical Safety Considerations for the Development of Antibody-Based Therapeutics
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72. The Scientific Value of Non-Clinical Animal Studies in Drug Development
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73. A novel approach for first‐in‐human dose selection using population dose–response modelling to find a minimum anticipated biological effect level
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75. De novo protein design: a transformative frontier in clinical protein applications
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76. Immunogenicity Lessons Learned from the Clinical Development of Vatreptacog Alfa, A Recombinant Activated Factor VII Analog, in Hemophilia with Inhibitors
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77. Clinical development of subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies—pharmacokinetic-based bridging approach
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78. Immunomodulatory Methods
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79. Early De-risking Strategy for Novel Biotherapeutics
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80. Pharmacokinetics and Safety Assessment
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81. Developability Assessment Workflows to De-Risk Biopharmaceutical Development
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83. A Global Perspective on First-in-Man Dose Selection: Oncology and Beyond
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84. An antidote approach to reduce risk and broaden utility of antibody-based therapeutics
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85. Clinical Pathology Assays in Immunopathology
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86. Ethical and practical issues in phase 1 trials in healthy volunteers
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87. Monoclonal Antibodies in Phase 1 and 2 Studies for Immunological Disorders
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88. Product characterization and preclinical evaluation of the biodistribution and safety of umbilical cord mesenchymal stromal cell-derived extracellular vesicles
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89. The Diverse Roles of Monoclonal Antibodies in Cancer Immunotherapy and Their Relative Effectiveness: A Literature Review
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90. Potential risks of occupational exposure to innovative biopharmaceuticals: a review
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92. Non-signaling protein therapeutics: a mechanism-based regulatory framework to modernize biosimilar development and global harmonization
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93. Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks
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94. Assessment of chronic toxicity study designs and development of a weight-of-evidence-based decision-making model for biopharmaceuticals: A survey of Japanese pharmaceutical companies
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95. Advantame as an ultra-high-potency artificial sweetener: chemical properties, metabolism, safety assessment, metabolic effects, and food technology applications: a comprehensive review
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96. Benefit-Risk of Immunomodulators in Multiple Sclerosis. Alemtuzumab and Next?
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97. Safety and Efficacy Evaluation Using Nonhuman Primates
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98. Preclinical Development of Monoclonal Antibodies
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