4,192
Views
97
CrossRef citations to date
0
Altmetric
Report

Immunogenicity of mAbs in non-human primates during nonclinical safety assessment

, , , , , & show all
Pages 810-816 | Received 22 Apr 2013, Accepted 31 May 2013, Published online: 06 Jun 2013

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (8)

Richard Graveline, Morad Haida, Carolyne Dumont, Dominic Poulin, Florence Poitout-Belissent, Rana Samadfam, Sven Kronenberg, Franziska Regenass-Lechner, Rodney Prell & Marie-Soleil Piche. (2022) Development of a nonhuman primate challenge model to evaluate CD8+ T cell responses to an adenovirus-based vaccine expressing SIV proteins upon repeat-dose treatment with checkpoint inhibitors. mAbs 14:1.
Read now
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. (2021) An integrated approach for characterizing immunogenic responses toward a bispecific antibody. mAbs 13:1.
Read now
Delphine Valente, Christine Mauriac, Thorsten Schmidt, Ingo Focken, Jochen Beninga, Brian Mackness, Huawei Qiu, Pascale Vicat, Abdullah Kandira, Katarina Radošević, Srini Rao, John Darbyshire & Mostafa Kabiri. (2020) Pharmacokinetics of novel Fc-engineered monoclonal and multispecific antibodies in cynomolgus monkeys and humanized FcRn transgenic mouse models. mAbs 12:1.
Read now
Lykke Boysen, Birgitte M. Viuff, Lone H. Landsy, Shari A. Price, James T. Raymond, Jens Lykkesfeldt & Brian Lauritzen. (2019) Formation and glomerular deposition of immune complexes in mice administered bovine serum albumin: Evaluation of dose, frequency, and biomarkers. Journal of Immunotoxicology 16:1, pages 191-200.
Read now
Frank R. Brennan, Joy Cavagnaro, Kathleen McKeever, Patricia C. Ryan, Melissa M. Schutten, John Vahle, Gerhard F. Weinbauer, Estelle Marrer-Berger & Lauren E. Black. (2018) Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment. mAbs 10:1, pages 1-17.
Read now
Fiona Sewell, Kathryn Chapman, Jessica Couch, Maggie Dempster, Shawn Heidel, Lise Loberg, Curtis Maier, Timothy K. Maclachlan, Marque Todd & Jan Willem van der Laan. (2017) Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use. mAbs 9:5, pages 742-755.
Read now

Articles from other publishers (89)

Endry H. T. Lim, Alexander P. J. Vlaar, Sanne de Bruin, Simon Rückinger, Claus Thielert, Maria Habel, Renfeng Guo, Bruce P. Burnett, James Dickinson, Matthijs C. Brouwer, Niels C. Riedemann, Diederik van de Beek, Martin Witzenrath, Pieter van Paassen, Leo M. A. Heunks, Bruno Mourvillier, Matthijs C. Brouwer, Pieter R. Tuinman, José Francisco K. Saraiva, Gernot Marx, Suzana M. Lobo, Rodrigo Boldo, Jesus A. Simon-Campos, Alexander D. Cornet, Anastasia Grebenyuk, Johannes M. Engelbrecht, Murimisi Mukansi, Philippe G. Jorens, Robert Zerbib, Korinna Pilz, Niels C. Riedemann, Pierre Bulpa, Fabio S. Taccone, Greet Hermans, Marc Diltoer, Michael Piagnerelli, Nikolaas De Neve, Antonio T. Freire, Felipe D. Pizzol, Anna Karolina Marinho, Victor H. Sato, Clovis Arns da Cunha, Mathilde Neuville, Jean Dellamonica, Djillali Annane, Antoine Roquilly, Jean Luc Diehl, Francis Schneider, Jean Paul Mira, Jean Baptiste Lascarrou, Luc Desmedt, Claire Dupuis, Carole Schwebel, Guillaume Thiéry, Matthias Gründling, Marc Berger, Tobias Welte, Michael Bauer, Ulrich Jaschinski, Klaus Matschke, Roberto Mercado-Longoria, Belinda Gomez Quintana, Jorge Alberto Zamudio-Lerma, Juan Moreno Hoyos Abril, Angel Aleman Marquez, Peter Pickkers, Luuk Otterspoor, Luis Hercilla Vásquez, Carlos Rafael Seas Ramos, Alejandro Peña Villalobos, Gonzalo Gianella Malca, Victoria Chávez, Victor Filimonov, Vladimir Kulabukhov, Pinak Acharya, Sjoerd A. M. E. G. Timmermans, Matthias H. Busch, Floor L. F. van Baarle, Rutger Koning, Liora ter Horst, Nora Chekrouni, Thijs M. van Soest, Marleen A. Slim, Lonneke A. van Vught, Rombout B. E. van Amstel, Sabine E. Olie, Ingeborg E. van Zeggeren, Marcel C. G. van de Poll & Dorothee Neukirchen. (2023) Pharmacokinetic analysis of vilobelimab, anaphylatoxin C5a and antidrug antibodies in PANAMO: a phase 3 study in critically ill,  invasively mechanically ventilated COVID-19 patients. Intensive Care Medicine Experimental 11:1.
Crossref
Tingting Liu, Yongliang Tong, Jinli Gao, Wenjing Fang, Junliang Wu, Xionghua Peng, Xiaotian Fan, Xiaoqiang Chen, Jianhua Sun, Sheldon Cao, Zhaohui Li, Likun Gong, Qiuping Qin & Dianwen Ju. (2023) Development of a bridging ELISA for detection of antibodies against ZV0203 in cynomolgus monkey serum. Journal of Pharmacological and Toxicological Methods 119, pages 107210.
Crossref
Martin R. Edelmann. (2022) Radiolabelling small and biomolecules for tracking and monitoring. RSC Advances 12:50, pages 32383-32400.
Crossref
Blaise Pasquiers, Salih Benamara, Mathieu Felices, Laurent Nguyen & Xavier Declèves. (2022) Review of the Existing Translational Pharmacokinetics Modeling Approaches Specific to Monoclonal Antibodies (mAbs) to Support the First-In-Human (FIH) Dose Selection. International Journal of Molecular Sciences 23:21, pages 12754.
Crossref
Nazneen Bano, Christopher Ehlinger, Tong-yuan Yang, Michael Swanson & Schantz Allen. (2022) Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs). The AAPS Journal 24:5.
Crossref
Martin A. Rossotti, Kasandra Bélanger, Kevin A. Henry & Jamshid Tanha. (2021) Immunogenicity and humanization of single‐domain antibodies. The FEBS Journal 289:14, pages 4304-4327.
Crossref
Jochem Gokemeijer. 2022. Bioanalytical Aspects in Biological Therapeutics. Bioanalytical Aspects in Biological Therapeutics 141 158 .
Jan Voorberg, Tim Postmus & Saskia Schols. (2022) Next generation FVIII mimetic bispecific antibody for hemophilia A. Journal of Thrombosis and Haemostasis 20:6, pages 1301-1305.
Crossref
Brian Lauritzen, Mads Bjelke, Olle Björkdahl, Esther Bloem, Kevin Keane, Marianne Kjalke, Marie Rossen, Solvej Lund Lippert, Karin Nana Weldingh, Mikala Skydsgaard & Stine Kjellev. (2022) A novel next‐generation FVIIIa mimetic, Mim8, has a favorable safety profile and displays potent pharmacodynamic effects: Results from safety studies in cynomolgus monkeys. Journal of Thrombosis and Haemostasis 20:6, pages 1312-1324.
Crossref
Eric M. Mucker, Carolin Thiele-Suess, Patrick Baumhof & Jay W. Hooper. (2022) Lipid nanoparticle delivery of unmodified mRNAs encoding multiple monoclonal antibodies targeting poxviruses in rabbits. Molecular Therapy - Nucleic Acids 28, pages 847-858.
Crossref
Nikki DeAngelis, Catherine Ferrante, Gordon Powers, Jocelyn Sendecki, Bethany Mattson, Darlene Pizutti, Kathryn Packman, Weirong Wang, Kevin Trouba, Rupesh Nanjunda, John Wheeler, Ray Brittingham, Sheng-Jiun Wu, Jinquan Luo, Matthew V. Lorenzi & Raluca I. Verona. (2022) Discovery and pharmacological characterization of cetrelimab (JNJ-63723283), an anti–programmed cell death protein-1 (PD-1) antibody, in human cancer models. Cancer Chemotherapy and Pharmacology 89:4, pages 515-527.
Crossref
Muriel Bellot, C. Marc Luetjens, Morten Bagger, Courtney Horvath, Esther Sutter, Anthony DeLise, Dominique Brees, José M. Carballido, Ratnakar Pingili, Krishnan Ramanathan, Bernd C. Kieseier & Kerstin Hellwig. (2022) Effect of ofatumumab on pregnancy, parturition, and lactation in cynomolgus monkeys. Reproductive Toxicology 108, pages 28-34.
Crossref
Patrick G. Holder, Shion A. Lim, Christine S. Huang, Preeti Sharma, Yavuz S. Dagdas, Beyza Bulutoglu & Jonathan T. Sockolosky. (2022) Engineering interferons and interleukins for cancer immunotherapy. Advanced Drug Delivery Reviews 182, pages 114112.
Crossref
Nancy Chen, Kefeng Sun, Nagendra Venkata Chemuturi, Hyelim Cho & Cindy Q. Xia. (2022) The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution. The AAPS Journal 24:1.
Crossref
Yun Jung Kim, Eun Mi Koh, Chi Hun Song, Mi Sun Byun, Yu Ri Choi, Eun-Jeong Jeon, Kyunghwa Hwang, Sang Kyum Kim, Sang In Yang & Kyung Jin Jung. (2021) Preclinical immunogenicity testing using anti-drug antibody analysis of GX-G3, Fc-fused recombinant human granulocyte colony-stimulating factor, in rat and monkey models. Scientific Reports 11:1.
Crossref
Miriam Manook, Walter J. Flores, Robin Schmitz, Zachary Fitch, Janghoon Yoon, Yeeun Bae, Brian Shaw, Allan Kirk, Melissa Harnois, Sallie Permar, Alton B. Farris, Diogo M. Magnani, Jean Kwun & Stuart Knechtle. (2021) Measuring the Impact of Targeting FcRn-Mediated IgG Recycling on Donor-Specific Alloantibodies in a Sensitized NHP Model. Frontiers in Immunology 12.
Crossref
Zachary A. Schiller, Michael J. Rudolph, Jacqueline R. Toomey, Monir Ejemel, Alan LaRochelle, Simon A. Davis, Havard S. Lambert, Aurélie Kern, Amanda C. Tardo, Colby A. Souders, Eric Peterson, Rebecca D. Cannon, Chandrashekar Ganesa, Frank Fazio, Nicholas J. Mantis, Lisa A. Cavacini, John Sullivan-Bolyai, Linden T. Hu, Monica E. Embers, Mark S. Klempner & Yang Wang. (2021) Blocking Borrelia burgdorferi transmission from infected ticks to nonhuman primates with a human monoclonal antibody. Journal of Clinical Investigation 131:11.
Crossref
Edward Dere, Susan Crowell, Mauricio Maia, Chris Schuetz, Phillip Lai, Vladimir Bantseev & Helen Booler. (2020) Nonclinical Safety Assessment of FHTR2163, An Antigen-Binding Fragment Against HTRA1 for the Treatment of Geographic Atrophy. Toxicologic Pathology 49:3, pages 610-620.
Crossref
Steven T. Laing, Nardos Tassew, Devin Tesar, Yue Wang, Susan R. Crowell, Julia Gray, Mandy Kwong, Kelly M. Loyet, Roxanne Andaya, Aija Kusi & Robert F. Kelley. (2020) Retinal and Lens Degeneration in New Zealand White Rabbits Administered Intravitreal TSG-6 Link Domain-Rabbit FAb Fusion Proteins. Toxicologic Pathology 49:3, pages 634-646.
Crossref
Vladimir Bantseev, Joshua Horvath, Giulio Barteselli, Shrirang Ranade, Mauricio Maia, Daniela Bumbaca Yadav, Chris Schuetz, Amy Shelton & Helen S. Booler. (2020) Nonclinical Toxicology and Biocompatibility Program Supporting Clinical Development and Registration of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration. Toxicologic Pathology 49:3, pages 663-672.
Crossref
Yi Wen & Vibha Jawa. (2021) The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics. Journal of Pharmaceutical Sciences 110:3, pages 1025-1041.
Crossref
Kun Peng, Ketevan Siradze & Saloumeh Kadkhodayan Fischer. (2021) Characterization of robust immune responses to a bispecific antibody, a novel class of antibody therapeutics. Bioanalysis 13:4, pages 239-252.
Crossref
Anthony Peter Hall, Annick Cauvin, Sherri Dudal, James Raymond, Petrina Rogerson & Jacquelin Jolette. (2020) Case Studies Discussing the Pathology, Immunogenicity, and Proposed Mechanism of Toxicity of an Inhaled Anti-TGFβ Humanized Fab Antibody in Non-Human Primates and Mice. Toxicologic Pathology 49:2, pages 315-333.
Crossref
Sharana Mahomed, Nigel Garrett, Quarraisha A Karim, Nonhlanhla Y Zuma, Edmund Capparelli, Cheryl Baxter, Tanuja Gengiah, Derseree Archary, Natasha Samsunder, Nicole D Rose, Penny Moore, Carolyn Williamson, Dan H Barouch, Patricia E Fast, Bruno Pozzetto, Catherine Hankins, Kevin Carlton, Julie Ledgerwood, Lynn Morris, John Mascola & Salim Abdool Karim. (2020) Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial. BMJ Open 10:11, pages e042247.
Crossref
Rosie Z. YuYanfeng WangDan A. NorrisTae-Won KimPadma NarayananRichard S. GearyBrett P. MoniaScott P. Henry. (2020) Immunogenicity Assessment of Inotersen, a 2′- O -(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety . Nucleic Acid Therapeutics 30:5, pages 265-275.
Crossref
Erik Doevendans & Huub Schellekens. (2020) Protein Quality Testing in the Era of Personalized Medicine. Journal of Pharmaceutical Sciences 109:10, pages 2962-2968.
Crossref
Ekaterina Breous-Nystrom, Sven Kronenberg, Estelle Marrer-Berger, Adrian Roth, Thierry Lave & Thomas Singer. (2020) Transforming preclinical assessment to meet clinical relevance with advanced models. Current Opinion in Toxicology 23-24, pages 39-45.
Crossref
Laura A. Vitale, Li-Zhen He, Lawrence J. Thomas, Anna Wasiuk, Thomas O’Neill, Jenifer Widger, Andrea Crocker, Laura Mills-Chen, Eric Forsberg, Jeffrey Weidlick, Colleen Patterson, Russell A. Hammond, James Boyer, Crystal Sisson, Diego Alvarado, Joel Goldstein, Henry C. MarshJr.Jr. & Tibor Keler. (2020) Development of CDX-527: a bispecific antibody combining PD-1 blockade and CD27 costimulation for cancer immunotherapy. Cancer Immunology, Immunotherapy 69:10, pages 2125-2137.
Crossref
Christine Karbowski, Rebecca Goldstein, Brendon Frank, Kei Kim, Chi-Ming Li, Oliver Homann, Kelly Hensley, Benjamin Brooks, Xiaoting Wang, Qinghong Yan, Rocio Hernandez, Gregor Adams, Michael Boyle, Tara Arvedson & Herve Lebrec. (2020) Nonclinical Safety Assessment of AMG 553, an Investigational Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Acute Myeloid Leukemia. Toxicological Sciences 177:1, pages 94-107.
Crossref
Ngoc B. Pham & Wilson S. Meng. (2020) Protein aggregation and immunogenicity of biotherapeutics. International Journal of Pharmaceutics 585, pages 119523.
Crossref
Lykke Boysen, Birgitte M. Viuff, Lone H. Landsy, Jens Lykkesfeldt, James T. Raymond, Shari A. Price, Hermann Pelzer & Brian Lauritzen. (2020) Formation and Glomerular Deposition of Immune Complexes in Mice Administered Human Antibodies: Evaluation of Dose, Frequency, and Biomarkers. Toxicologic Pathology 48:4, pages 570-585.
Crossref
Kristy Fu, Kylie March, Aikaterini Alexaki, Giulia Fabozzi, Eirini Moysi & Constantinos Petrovas. (2020) Immunogenicity of Protein Therapeutics: A Lymph Node Perspective. Frontiers in Immunology 11.
Crossref
Jing Zhang, Jizu Yi & Pengfei Zhou. (2020) Development of bispecific antibodies in China: overview and prospects. Antibody Therapeutics 3:2, pages 126-145.
Crossref
Mazin Derzi, Ahmed M. Shoieb, Sharon L. Ripp, Gregory L. Finch, Leslie G. Lorello, Shawn P. O'Neil, Zaher Radi, Jameel Syed, Matthew S. Thompson & Michael W. Leach. (2020) Comparative nonclinical assessments of the biosimilar PF-06410293 and originator adalimumab. Regulatory Toxicology and Pharmacology 112, pages 104587.
Crossref
Sebastian P. Fuchs, José M. Martinez-Navio, Eva G. Rakasz, Guangping Gao & Ronald C. Desrosiers. (2020) Liver-Directed but Not Muscle-Directed AAV-Antibody Gene Transfer Limits Humoral Immune Responses in Rhesus Monkeys. Molecular Therapy - Methods & Clinical Development 16, pages 94-102.
Crossref
Mathieu Angin, Chrystelle Brignone & Frédéric Triebel. (2020) A LAG-3–Specific Agonist Antibody for the Treatment of T Cell–Induced Autoimmune Diseases. The Journal of Immunology 204:4, pages 810-818.
Crossref
Diego Enrico, Angelo Paci, Nathalie Chaput, Eleni Karamouza & Benjamin Besse. (2020) Antidrug Antibodies Against Immune Checkpoint Blockers: Impairment of Drug Efficacy or Indication of Immune Activation?. Clinical Cancer Research 26:4, pages 787-792.
Crossref
Annalee W. Nguyen, Andrea M. DiVenere, James F. Papin, Sheila Connelly, Michael Kaleko & Jennifer A. Maynard. (2020) Neutralization of pertussis toxin by a single antibody prevents clinical pertussis in neonatal baboons. Science Advances 6:6, pages eaay9258.
Crossref
Yuliya Yakymiv, Stefania Augeri, Giulia Fissolo, Silvia Peola, Cristiano Bracci, Monica Binaschi, Daniela Bellarosa, Andrea Pellacani, Enza Ferrero, Erika Ortolan & Ada Funaro. (2019) CD157: From Myeloid Cell Differentiation Marker to Therapeutic Target in Acute Myeloid Leukemia. Cells 8:12, pages 1580.
Crossref
Veena A. Thomas & Joseph P. Balthasar. (2019) Understanding Inter-Individual Variability in Monoclonal Antibody Disposition. Antibodies 8:4, pages 56.
Crossref
Tracy L. Staton, Kun Peng, Ryan Owen, David F. Choy, Christopher R. Cabanski, Alice Fong, Flavia Brunstein, Kathila R. Alatsis & Hubert Chen. (2019) A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers. BMC Pulmonary Medicine 19:1.
Crossref
Krystal Teasley Hamorsky, J. Calvin Kouokam, Matthew W. Dent, Tiffany N. Grooms, Adam S. Husk, Steven D. Hume, Kenneth A. Rogers, Francois Villinger, Mary Kate Morris, Carl V. Hanson & Nobuyuki Matoba. (2019) Engineering of a Lectibody Targeting High-Mannose-Type Glycans of the HIV Envelope. Molecular Therapy 27:11, pages 2038-2052.
Crossref
Sophie Tourdot & Timothy P Hickling. (2019) Nonclinical immunogenicity risk assessment of therapeutic proteins. Bioanalysis 11:17, pages 1631-1643.
Crossref
David Crawford & Mitchell Friedman. (2019) Evaluation of the Developmental Toxicity of Vedolizumab, an α 4 β 7 Receptor Antagonist, in Rabbit and Nonhuman Primate . International Journal of Toxicology 38:5, pages 395-404.
Crossref
Paul Baldrick. (2019) Nonclinical Immunotoxicity Testing in the Pharmaceutical World: The Past, Present, and Future. Therapeutic Innovation & Regulatory Science, pages 216847901986455.
Crossref
Meiyu XuJia LiJun XieRan HeQin SuGuangping GaoPhillip W.L. Tai. (2019) High-Throughput Quantification of In Vivo Adeno-Associated Virus Transduction with Barcoded Non-Coding RNAs . Human Gene Therapy 30:8, pages 946-956.
Crossref
Evan A. Thackaberry, Florence Lorget, Cindy Farman & Vladimir Bantseev. (2019) The safety evaluation of long-acting ocular delivery systems. Drug Discovery Today 24:8, pages 1539-1550.
Crossref
Helen Prior, Thomas Monticello, Virginie Boulifard, Frank R. Brennan & Ian Kimber. (2019) Integration of Consortia Recommendations for Justification of Animal Use Within Current and Future Drug Development Paradigms. International Journal of Toxicology 38:4, pages 319-325.
Crossref
Rianne N. Esquivel, Ami Patel, Sagar B. Kudchodkar, Daniel H. Park, Karin Stettler, Martina Beltramello, Jeffrey W. Allen, Janess Mendoza, Stephanie Ramos, Hyeree Choi, Piyush Borole, Kanika Asija, Mamadou Bah, Shareef Shaheen, Jing Chen, Jian Yan, Amy C. Durham, Trevor R.F. Smith, Kate Broderick, Ghiabe Guibinga, Kar Muthumani, Davide Corti, Laurent Humeau & David B. Weiner. (2019) In Vivo Delivery of a DNA-Encoded Monoclonal Antibody Protects Non-human Primates against Zika Virus. Molecular Therapy 27:5, pages 974-985.
Crossref
Robert Dingman & Sathy V. Balu-Iyer. (2019) Immunogenicity of Protein Pharmaceuticals. Journal of Pharmaceutical Sciences 108:5, pages 1637-1654.
Crossref
Lotte A. Minnema, Thijs J. Giezen, Helga Gardarsdottir, Toine C. G. Egberts, Hubert G. M. Leufkens & Aukje K. Mantel‐Teeuwisse. (2019) Post‐marketing dosing changes in the label of biologicals. British Journal of Clinical Pharmacology 85:4, pages 715-721.
Crossref
Kendall S. Frazier. 2019. Toxicologic Pathology for Non-Pathologists. Toxicologic Pathology for Non-Pathologists 201 250 .
Kendall S. Frazier & Leslie A. Obert. (2018) Drug-induced Glomerulonephritis: The Spectre of Biotherapeutic and Antisense Oligonucleotide Immune Activation in the Kidney. Toxicologic Pathology 46:8, pages 904-917.
Crossref
Jane Harper, Katherine J. Adams, Giovanna Bossi, Debbie E. Wright, Andrea R. Stacey, Nicole Bedke, Ruth Martinez-Hague, Dan Blat, Laure Humbert, Hazel Buchanan, Gabrielle S. Le Provost, Zoe Donnellan, Ricardo J. Carreira, Samantha J. Paston, Luise U. Weigand, Martina Canestraro, Joseph P. Sanderson, Sophie Botta Gordon-Smith, Kate L. Lowe, Karolina A. Rygiel, Alex S. Powlesland, Annelise Vuidepot, Namir J. Hassan, Brian J. Cameron, Bent K. Jakobsen & Joseph Dukes. (2018) An approved in vitro approach to preclinical safety and efficacy evaluation of engineered T cell receptor anti-CD3 bispecific (ImmTAC) molecules. PLOS ONE 13:10, pages e0205491.
Crossref
Floriane Groell, Olivier Jordan & Gerrit Borchard. (2018) In vitro models for immunogenicity prediction of therapeutic proteins. European Journal of Pharmaceutics and Biopharmaceutics 130, pages 128-142.
Crossref
Frank-Jan Warnders, Marjolijn N. Lub-de Hooge, Elisabeth G. E. de Vries & Jos G. W. Kosterink. (2018) Influence of protein properties and protein modification on biodistribution and tumor uptake of anticancer antibodies, antibody derivatives, and non-Ig scaffolds. Medicinal Research Reviews 38:6, pages 1837-1873.
Crossref
Marjorie A. Peraza, Karen E. Rule, Michael H.I. Shiue, Gregory L. Finch, Stéphane Thibault, Paul R. Brown, David W. Clarke & Michael W. Leach. (2018) Nonclinical assessments of the potential biosimilar PF-06439535 and bevacizumab. Regulatory Toxicology and Pharmacology 95, pages 236-243.
Crossref
Haruna Sasaki-Iwaoka, Makoto Ohori, Akira Imasato, Katsunari Taguchi, Kyoko Minoura, Tetsu Saito, Kiyoshi Kushima, Emiko Imamura, Satoshi Kubo, Shigetada Furukawa & Tatsuaki Morokata. (2018) Generation and characterization of a potent fully human monoclonal antibody against the interleukin-23 receptor. European Journal of Pharmacology 828, pages 89-96.
Crossref
Weirong Wang, Jocelyn Leu, Rebecca Watson, Zhenhua Xu & Honghui Zhou. (2018) Investigation of the Mechanism of Therapeutic Protein-Drug Interaction Between Methotrexate and Golimumab, an Anti-TNFα Monoclonal Antibody. The AAPS Journal 20:3.
Crossref
Gregory Z. Ferl, Arthur Reyes, Liping L. Sun, Melissa Cheu, Amy Oldendorp, Saroja Ramanujan & Eric G. Stefanich. (2018) A Preclinical Population Pharmacokinetic Model for Anti-CD20/CD3 T-Cell-Dependent Bispecific Antibodies. Clinical and Translational Science 11:3, pages 296-304.
Crossref
Vladimir BantseevRebecca EricksonDouglas LeipoldCaroline AmayaPaul E. MillerHelen BoolerEvan A. Thackaberry. (2018) Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics. Journal of Ocular Pharmacology and Therapeutics 34:1-2, pages 204-213.
Crossref
Akiko Ishii-Watabe, Hiroko Shibata, Kazuko Nishimura, Jun Hosogi, Muneo Aoyama, Kazuhiro Nishimiya & Yoshiro Saito. (2018) Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan. Bioanalysis 10:2, pages 95-105.
Crossref
Noriko Iwamoto, Akinobu Hamada & Takashi Shimada. (2018) Antibody drug quantitation in coexistence with anti-drug antibodies on nSMOL bioanalysis. Analytical Biochemistry 540-541, pages 30-37.
Crossref
L. Mihalcik, J.L. Bussiere, V. Jawa, M. Lepherd, D.T. Mytych, A. Sharma, M.P. Sirivelu & N. Everds. 2018. Comprehensive Toxicology. Comprehensive Toxicology 498 517 .
Liming Liu. (2017) Pharmacokinetics of monoclonal antibodies and Fc-fusion proteins. Protein & Cell 9:1, pages 15-32.
Crossref
Sven Kronenberg, Elisabeth Husar, Christine Schubert, Christian Freichel, Thomas Emrich, Martin Lechmann, Anna Maria Giusti & Franziska Regenass. (2017) Comparative assessment of immune complex-mediated hypersensitivity reactions with biotherapeutics in the non-human primate: Critical parameters, safety and lessons for future studies. Regulatory Toxicology and Pharmacology 88, pages 125-137.
Crossref
Christophe Arnoult, Guillaume Brachet, Diana Cadena Castaneda, Nicolas Azzopardi, Christophe Passot, Celine Desvignes, Gilles Paintaud, Nathalie Heuzé-Vourc’h, Hervé Watier & Valérie Gouilleux-Gruart. (2017) Crucial Role for Immune Complexes but Not FcRn in Immunization against Anti–TNF-α Antibodies after a Single Injection in Mice. The Journal of Immunology 199:2, pages 418-424.
Crossref
Huub Schellekens, Mohammed Aldosari, Herre Talsma & Enrico Mastrobattista. (2017) Making individualized drugs a reality. Nature Biotechnology 35:6, pages 507-513.
Crossref
Kirsten M. Mease, Amy L. Kimzey & Janice A. Lansita. (2017) Biomarkers for nonclinical infusion reactions in marketed biotherapeutics and considerations for study design. Current Opinion in Toxicology 4, pages 1-15.
Crossref
Shruti Agrawal, Paul Statkevich, Gaurav Bajaj, Yan Feng, Sally Saeger, Dharmesh D. Desai, Jong-Soon Park, Ian M. Waxman, Amit Roy & Manish Gupta. (2017) Evaluation of Immunogenicity of Nivolumab Monotherapy and Its Clinical Relevance in Patients With Metastatic Solid Tumors. The Journal of Clinical Pharmacology 57:3, pages 394-400.
Crossref
Mark J. Prescott, Jan A. Langermans & Ian Ragan. (2017) Applying the 3Rs to non-human primate research: Barriers and solutions. Drug Discovery Today: Disease Models 23, pages 51-56.
Crossref
Breno C.B. Beirão, Teresa Raposo, Saurabh Jain, Ted Hupp & David J. Argyle. (2016) Challenges and opportunities for monoclonal antibody therapy in veterinary oncology. The Veterinary Journal 218, pages 40-50.
Crossref
Franziska Regenass-Lechner, Roland F. Staack, Jean-Luc Mary, Wolfgang F. Richter, Michael Winter, Gregor Jordan, Nicole Justies, Anja Langenkamp, Rosario Garrido, Mudher Albassam, Thomas Singer & Elke-Astrid Atzpodien. (2016) Immunogenicity, Inflammation, and Lipid Accumulation in Cynomolgus Monkeys Infused with a Lipidated Tetranectin-ApoA-I Fusion Protein. Toxicological Sciences 150:2, pages 378-389.
Crossref
Alison Smith, Hugh Manoli, Stacey Jaw, Kimberley Frutoz, Alan L. Epstein, Leslie A. Khawli & Frank-Peter Theil. (2016) Unraveling the Effect of Immunogenicity on the PK/PD, Efficacy, and Safety of Therapeutic Proteins. Journal of Immunology Research 2016, pages 1-9.
Crossref
Sebastian P Fuchs & Ronald C Desrosiers. (2016) Promise and problems associated with the use of recombinant AAV for the delivery of anti-HIV antibodies. Molecular Therapy - Methods & Clinical Development 3, pages 16068.
Crossref
Theresa Yuraszeck & Megan Gibbs. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia 1 15 .
Sue TownsendBrian J. FennellJames R. ApgarMatthew LambertBarry McDonnellJoanne GrantJason WadeEdward FranklinNiall FoyDeirdre Ní ShúilleabháinConor FieldsAlfredo Darmanin-SheehanAmy KingJanet E. PaulsenTimothy P. Hickling, Lioudmila TchistiakovaOrla CunninghamWilliam J. J. Finlay. (2015) Augmented Binary Substitution: Single-pass CDR germ-lining and stabilization of therapeutic antibodies. Proceedings of the National Academy of Sciences 112:50, pages 15354-15359.
Crossref
Kendall S. Frazier, Jeffery A. Engelhardt, Pierluigi Fant, Silvia Guionaud, Scott P. Henry, Michael W. Leach, Calvert Louden, Marshall S. Scicchitano, James L. Weaver & Tanja S. Zabka. (2015) Scientific and Regulatory Policy Committee Points-to-consider Paper*. Toxicologic Pathology 43:7, pages 915-934.
Crossref
Jie Liu, Lijuan Wang, Feifei Zhao, Serena Tseng, Cyndhavi Narayanan, Lei Shura, Stephen Willingham, Maureen Howard, Susan Prohaska, Jens Volkmer, Mark Chao, Irving L. Weissman & Ravindra Majeti. (2015) Pre-Clinical Development of a Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. PLOS ONE 10:9, pages e0137345.
Crossref
Kevin O. Saunders, Lingshu Wang, M. Gordon Joyce, Zhi-Yong Yang, Alejandro B. Balazs, Cheng Cheng, Sung-Youl Ko, Wing-Pui Kong, Rebecca S. Rudicell, Ivelin S. Georgiev, Lijie Duan, Kathryn E. Foulds, Mitzi Donaldson, Ling Xu, Stephen D. Schmidt, John-Paul Todd, David Baltimore, Mario Roederer, Ashley T. Haase, Peter D. Kwong, Srinivas S. Rao, John R. Mascola & Gary J. Nabel. (2015) Broadly Neutralizing Human Immunodeficiency Virus Type 1 Antibody Gene Transfer Protects Nonhuman Primates from Mucosal Simian-Human Immunodeficiency Virus Infection. Journal of Virology 89:16, pages 8334-8345.
Crossref
Peter J.K. van Meer, Melanie L. Graham & Henk-Jan Schuurman. (2015) The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals. European Journal of Pharmacology 759, pages 3-13.
Crossref
Kevin O. Saunders, Amarendra Pegu, Ivelin S. Georgiev, Ming Zeng, M. Gordon Joyce, Zhi-Yong Yang, Sung-Youl Ko, Xuejun Chen, Stephen D. Schmidt, Ashley T. Haase, John-Paul Todd, Saran Bao, Peter D. Kwong, Srinivas S. Rao, John R. Mascola & Gary J. Nabel. (2015) Sustained Delivery of a Broadly Neutralizing Antibody in Nonhuman Primates Confers Long-Term Protection against Simian/Human Immunodeficiency Virus Infection. Journal of Virology 89:11, pages 5895-5903.
Crossref
Marie-Soleil Piché, Barbara Mounho-Zamora, Lynne LeSauteur & Leigh Ann Burns-Naas. 2015. The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment. The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment 519 542 .
Thomas Gelzleichter & Eric Wakshull. 2015. The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment. The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment 457 467 .
Jan Willem van der Laan, Carla Herberts, David Jones, Susan J Thorpe, Richard Stebbings & Robin Thorpe. 2014. Molecular Immunotoxicology. Molecular Immunotoxicology 189 208 .
Melody Sauerborn. 2014. Handbook of Therapeutic Antibodies. Handbook of Therapeutic Antibodies 665 680 .
Susanna Penco, Elena Venco & Alfredo Lio. (2014) Lost in Translation: The Need for Better Tools. Alternatives to Laboratory Animals 42:4, pages P41-P45.
Crossref
Changyu Wang, Kent B. Thudium, Minhua Han, Xi-Tao Wang, Haichun Huang, Diane Feingersh, Candy Garcia, Yi Wu, Michelle Kuhne, Mohan Srinivasan, Sujata Singh, Susan Wong, Neysa Garner, Heidi Leblanc, R. Todd Bunch, Diann Blanset, Mark J. Selby & Alan J. Korman. (2014) In Vitro Characterization of the Anti-PD-1 Antibody Nivolumab, BMS-936558, and In Vivo Toxicology in Non-Human Primates . Cancer Immunology Research 2:9, pages 846-856.
Crossref
Jennifer L. Rojko, Mark G. Evans, Shari A. Price, Bora Han, Gary Waine, Mark DeWitte, Jill Haynes, Bruce Freimark, Pauline Martin, James T. Raymond, Winston Evering, Marlon C. Rebelatto, Emanuel Schenck & Christopher Horvath. (2014) Formation, Clearance, Deposition, Pathogenicity, and Identification of Biopharmaceutical-related Immune Complexes. Toxicologic Pathology 42:4, pages 725-764.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.