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Review

Ensuring the quality, potency and safety of vaccines during preclinical development

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Pages 855-866 | Published online: 09 Jan 2014

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Yun Liao, Qinfang Jiang, Xinqian Huo, Li Yu, Jinling Yang, Heng Zhao, Dandan Li, Xingli Xu, Guorun Jiang, Caixing Zhang, Cong Li, Yun Li, Ying Zhang, Mingxiang Shao, Baofeng Liu, Lianzhong Shen, Shengtao Fan & Qihan Li. (2023) Preclinical safety evaluation of a bivalent inactivated EV71-CA16 vaccine in mice immunized intradermally. Human Vaccines & Immunotherapeutics 19:1.
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Sergio Rosales-Mendoza & Carlos Angulo. (2015) Bacillus subtilis comes of age as a vaccine production host and delivery vehicle. Expert Review of Vaccines 14:8, pages 1135-1148.
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Bernard Metz, Germie van den Dobbelsteen, Cécile van Els, Johan van der Gun, Lonneke Levels, Leo van der Pol, Nynke Rots & Gideon Kersten. (2009) Quality-control issues and approaches in vaccine development. Expert Review of Vaccines 8:2, pages 227-238.
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Yuxuan Zhang, Yao Wu, Chong Peng, Zixuan Li, Gang Wang, Hui Wang, Lanping Yu & Fangkun Wang. (2023) Both recombinant Bacillus subtilis Expressing PCV2d Cap protein and PCV2d-VLPs can stimulate strong protective immune responses in mice. Heliyon 9:12, pages e22941.
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Sudip Kumar Dutta & Thomas Langenburg. (2023) A Perspective on Current Flavivirus Vaccine Development: A Brief Review. Viruses 15:4, pages 860.
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Camille Houy, Marin Ming, Luciano Ettorre, Robbie Jin, Nemika Thangavadivel, Tricia Chen, Jin Su & Beata Gajewska. (2022) Epitope Profiling of Diphtheria Toxoid Provides Enhanced Monitoring for Consistency Testing during Manufacturing Process Changes. Vaccines 10:5, pages 775.
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Michael J. Engwall, Weston Sutherland & Hugo M. Vargas. 2022. Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays 1 16 .
Ziyan Wang, Chenliang Zhou, Fan Gao, Qianjun Zhu, Yuanxiang Jiang, Xinxing Ma, Yalin Hu, Likang Shi, Xiaoliang Wang, Chao Zhang, Baofeng Liu, Lianzhong Shen, Qunying Mao & Ge Liu. (2021) Preclinical evaluation of recombinant HFMD vaccine based on enterovirus 71 (EV71) virus-like particles (VLP): Immunogenicity, efficacy and toxicology. Vaccine 39:31, pages 4296-4305.
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Vladimir Savransky, Michael Lacy, Boris Ionin, Mario H. Skiadopoulos & Jeffry Shearer. (2019) Repeat-Dose Toxicity Study of a Lyophilized Recombinant Protective Antigen-Based Anthrax Vaccine Adjuvanted With CpG 7909. International Journal of Toxicology 38:3, pages 163-172.
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Cécile Artaud, Leila Kara & Odile Launay. 2019. Malaria Control and Elimination. Malaria Control and Elimination 165 176 .
Faez Amokrane Nait Mohamed, Abdelmounaim Nouri & Fatima Laraba-Djebari. (2017) Reactogenicity and safety assessment of an attenuated nanovaccine against scorpion envenomation: Preclinical study. Vaccine 35:48, pages 6657-6663.
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Gokul Swaminathan, Elizabeth A. Thoryk, Kara S. Cox, Jeffrey S. Smith, Jayanthi J. Wolf, Marian E. Gindy, Danilo R. Casimiro & Andrew J. Bett. (2016) A Tetravalent Sub-unit Dengue Vaccine Formulated with Ionizable Cationic Lipid Nanoparticle induces Significant Immune Responses in Rodents and Non-Human Primates. Scientific Reports 6:1.
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Hamid R. Amouzadeh, Michael J. Engwall & Hugo M. Vargas. 2015. Principles of Safety Pharmacology. Principles of Safety Pharmacology 385 404 .
Rick Perry, Georgia Farris, Jean-Guy Bienvenu, Charles DeanJrJr, George Foley, Chuck Mahrt & Brian Short. (2013) Society of Toxicologic Pathology Position Paper on Best Practices on Recovery Studies. Toxicologic Pathology 41:8, pages 1159-1169.
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Jessica L. Price, T. Scott Manetz, Jeffry D. Shearer & Robert V. House. (2013) Preclinical Safety Assessment of a Recombinant Plague Vaccine (rF1V). International Journal of Toxicology 32:5, pages 327-335.
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Karin Hardt, Ruprecht Schmidt-Ott, Steffen Glismann, Richard Adegbola & François Meurice. (2013) Sustaining Vaccine Confidence in the 21st Century. Vaccines 1:3, pages 204-224.
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Jeffry D. Shearer, T. Scott Manetz & Robert V. House. (2012) Preclinical safety assessment of recombinant botulinum vaccine A/B (rBV A/B). Vaccine 30:11, pages 1917-1926.
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Cristina Gil, Núria Climent, Felipe García, Carmen Hurtado, Sara Nieto-Márquez, Agathe León, M Teresa García, Cristina Rovira, Laia Miralles, Judith Dalmau, Tomás Pumarola, Manel Almela, Javier Martinez-Picado, Jeffrey D. Lifson, Laura Zamora, José M. Miró, Christian Brander, Bonaventura Clotet, Teresa Gallart & José M. Gatell. (2011) Ex vivo production of autologous whole inactivated HIV-1 for clinical use in therapeutic vaccines. Vaccine 29:34, pages 5711-5724.
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Shayne Cox GadA. Marguerite Dempster & Richard Haworth. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia.
Catherine Kaplanski, Jose Lebron, Jayanthi Wolf & Brian Ledwith. 2008. Immunotoxicology Strategies for Pharmaceutical Safety Assessment. Immunotoxicology Strategies for Pharmaceutical Safety Assessment 229 237 .
Mary Kate Hart, Mark Bolanowski & Robert V. House. 2008. Immunotoxicology Strategies for Pharmaceutical Safety Assessment. Immunotoxicology Strategies for Pharmaceutical Safety Assessment 217 228 .
Joël Ménard. (2007) A vaccine for hypertension. Journal of Hypertension 25:1, pages 41-46.
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David J Snodin & Peter R Ryle. (2006) Understanding and Applying Regulatory Guidance on the Nonclinical Development of Biotechnology-Derived Pharmaceuticals. BioDrugs 20:1, pages 25-52.
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