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Review

Quality-control issues and approaches in vaccine development

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Pages 227-238 | Published online: 09 Jan 2014

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

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Emmanuel Vidor & Benoit Soubeyrand. (2016) Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools. Expert Review of Vaccines 15:12, pages 1575-1582.
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Venkatesan Saravanan, Bharath Kumar Chagaleti, Pavithra Lakshmi Narayanan, Vijay Babu Anandan, Haritha Manoharan, G.V. Anjana, Ramalingam Peraman, S. Karthik Raja Namasivayam, M. Kavisri, Jesu Arockiaraj, Kathiravan Muthu Kumaradoss & Meivelu Moovendhan. (2023) Discovery and development of COVID ‐19 vaccine from laboratory to clinic . Chemical Biology & Drug Design.
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Mingxia Sun, Shanghui Wang, Zheng Fang, Man Zhao, Yanfei Gao, Tongqing An, Yabin Tu, Haiwei Wang & Xuehui Cai. (2022) A Sandwich ELISA for Quality Control of PCV2 Virus-like Particles Vaccine. Vaccines 10:12, pages 2175.
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Yanli Yang, Ming Li, Yi Zhao, Xuan Lin, Zhiguo Su, Fei Xin, Xiaojie Du, Kan Zheng, Rui Han, Yiping Pan, Sun He & Songping Zhang. (2022) Mechanism and inhibition of abnormal chromatographic behavior of serotype type a inactivated foot and mouth disease virus in high-performance size-exclusion chromatography. Journal of Chromatography A 1686, pages 463648.
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Raquel de M. Barbosa, Amélia M. Silva, Classius F. da Silva, Juliana C. Cardoso, Patricia Severino, Lyghia M. A. Meirelles, Arnobio A. da Silva-Junior, César Viseras, Joel Fonseca & Eliana B. Souto. (2022) Production Technologies, Regulatory Parameters, and Quality Control of Vaccine Vectors for Veterinary Use. Technologies 10:5, pages 109.
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Zehui Qu, Hongtao Kang, Chenxi Cui, Kaiwen Meng, Xinzheng Zhang, Liandong Qu, Yueping Zhang & Geng Meng. (2022) Purification-induced damage to calicivirus particles at near-atomic resolution. Journal of General Virology 103:5.
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Tyler Chozinski, B. Scott Ferguson, William Fisher, Shencheng GeQiang Gong, Hui Kang, John McDermott, Alexander Scott, Wentao Shi, Jeremiah J. Trausch, Thorsten Verch, Matthew Vukovich, Jinpeng Wang, J. Emma Wu & Qin Yang. (2022) Development of an Aptamer-Based Electrochemical Microfluidic Device for Viral Vaccine Quantitation. Analytical Chemistry 94:16, pages 6146-6155.
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Gabriela M. Escalante, Lorraine Z. Mutsvunguma, Murali Muniraju, Esther Rodriguez & Javier Gordon Ogembo. (2022) Four Decades of Prophylactic EBV Vaccine Research: A Systematic Review and Historical Perspective. Frontiers in Immunology 13.
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Tanja Opriessnig, Ashley A. Mattei, Anbu K. Karuppannan & Patrick G. Halbur. (2021) Future perspectives on swine viral vaccines: where are we headed?. Porcine Health Management 7:1.
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Angela Bechini, Paolo Bonanni, Beatrice Zanella, Giulia Di Pisa, Andrea Moscadelli, Sonia Paoli, Leonardo Ancillotti, Benedetta Bonito & Sara Boccalini. (2021) Vaccine Production Process: How Much Does the General Population Know about This Topic? A Web-Based Survey. Vaccines 9:6, pages 564.
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Qian Niu, Ling Ma, Shaobin Zhu, Lan Li, Qisheng Zheng, Jibo Hou, Hong Lian, Lina Wu & Xiaomei Yan. (2021) Quantitative Assessment of the Physical Virus Titer and Purity by Ultrasensitive Flow Virometry. Angewandte Chemie International Edition 60:17, pages 9351-9356.
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Qian Niu, Ling Ma, Shaobin Zhu, Lan Li, Qisheng Zheng, Jibo Hou, Hong Lian, Lina Wu & Xiaomei Yan. (2021) Quantitative Assessment of the Physical Virus Titer and Purity by Ultrasensitive Flow Virometry. Angewandte Chemie 133:17, pages 9437-9442.
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Vicki A. Montgomery, Changhong Y. Lindsey, Leonard A. Smith & Robert P. Webb. (2021) Development of an o-pthalaldehyde (OPA) assay to measure protein content in Ricin Vaccine E. coli (RVEc™). Vaccine 39:3, pages 564-570.
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Yanli Yang, Zhiguo Su, Guanghui Ma & Songping Zhang. (2020) Characterization and stabilization in process development and product formulation for super large proteinaceous particles. Engineering in Life Sciences 20:11, pages 451-465.
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Peter L. Stern. (2020) Key steps in vaccine development. Annals of Allergy, Asthma & Immunology 125:1, pages 17-27.
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Katharine T. Briggs, Marc B. Taraban & Y. Bruce Yu. (2020) Quality assurance at the point-of-care: Noninvasively detecting vaccine freezing variability using water proton NMR. Vaccine 38:31, pages 4853-4860.
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Yanli Yang, Yanmin Song, Xuan Lin, Shuai Li, Zhengjun Li, Qizu Zhao, Guanghui Ma, Songping Zhang & Zhiguo Su. (2020) Mechanism of bio-macromolecule denaturation on solid-liquid surface of ion-exchange chromatographic media – A case study for inactivated foot-and-mouth disease virus. Journal of Chromatography B 1142, pages 122051.
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Ajab Khan, Anam Ahsan, Muhammad Asim Farooq, Mirza Muhammad Faran Ashraf Baig & Qurat-ul-ain Aslam. 2020. Drug Stability and Chemical Kinetics. Drug Stability and Chemical Kinetics 167 185 .
Vanina Alzogaray, Mariela Urrutia, Paula Berguer, Andrés Rossi, Vanesa Zylberman, Romina Pardo, Hernán R. Bonomi & Fernando A. Goldbaum. (2019) Characterization of folding-sensitive nanobodies as tools to study the expression and quality of protein particle immunogens. Journal of Biotechnology 293, pages 17-23.
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B. Soubeyrand. (2018) De la fabrication d’un vaccin à sa mise à disposition en pharmacie. Revue des Maladies Respiratoires 35:10, pages 1005-1019.
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Scott Preiss, Nathalie Garçon, Anthony L. Cunningham, Richard Strugnell & Leonard R. Friedland. (2016) Vaccine provision: Delivering sustained & widespread use. Vaccine 34:52, pages 6665-6671.
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Christopher Ladd Effio, Stefan A. Oelmeier & Jürgen Hubbuch. (2016) High-throughput characterization of virus-like particles by interlaced size-exclusion chromatography. Vaccine 34:10, pages 1259-1267.
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Mengran Yu, Songping Zhang, Yan Zhang, Yanli Yang, Guanghui Ma & Zhiguo Su. (2015) Microcalorimetric study of adsorption and disassembling of virus-like particles on anion exchange chromatography media. Journal of Chromatography A 1388, pages 195-206.
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Yanli Yang, Hao Li, Zhengjun Li, Yan Zhang, Songping Zhang, Yi Chen, Mengran Yu, Guanghui Ma & Zhiguo Su. (2015) Size-exclusion HPLC provides a simple, rapid, and versatile alternative method for quality control of vaccines by characterizing the assembly of antigens. Vaccine 33:9, pages 1143-1150.
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Ozan S. Kumru, Sangeeta B. Joshi, Dawn E. Smith, C. Russell Middaugh, Ted Prusik & David B. Volkin. (2014) Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies. Biologicals 42:5, pages 237-259.
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Leo van der Pol & Jean-Pierre Amorij. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia 1 26 .
Jean-Pierre Amorij, Gideon F.A. Kersten, Vinay Saluja, Wouter F. Tonnis, Wouter L.J. Hinrichs, Bram Slütter, Suzanne M. Bal, Joke A. Bouwstra, Anke Huckriede & Wim Jiskoot. (2012) Towards tailored vaccine delivery: Needs, challenges and perspectives. Journal of Controlled Release 161:2, pages 363-376.
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Jessica O. Josefsberg & Barry Buckland. (2012) Vaccine process technology. Biotechnology and Bioengineering 109:6, pages 1443-1460.
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Qinjian Zhao, Victoria Towne, Martha Brown, Yang Wang, Dicky Abraham, C. Brent Oswald, Juan A. Gimenez, Michael W. Washabaugh, Ronald Kennedy & Robert D. Sitrin. (2011) In-depth process understanding of RECOMBIVAX HB® maturation and potential epitope improvements with redox treatment: Multifaceted biochemical and immunochemical characterization. Vaccine 29:45, pages 7936-7941.
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Bram Slütter, Peter Christiaan Soema, Zhi Ding, Rolf Verheul, Wim Hennink & Wim Jiskoot. (2010) Conjugation of ovalbumin to trimethyl chitosan improves immunogenicity of the antigen. Journal of Controlled Release 143:2, pages 207-214.
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Neil RavenscroftJun X Wheeler & Christopher Jones. (2010) Bioanalysis of meningococcal vaccines. Bioanalysis 2:2, pages 343-361.
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Daming Zhu, Allan Saul, Shuhui Huang, Laura B. Martin, Louis H. Miller & Kelly M. Rausch. (2009) Use of o-phthalaldehyde assay to determine protein contents of Alhydrogel-based vaccines. Vaccine 27:43, pages 6054-6059.
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