Virus-like particle-based human vaccines: quality assessment based on structural and functional properties

• Published in: Trends in biotechnology (Regular ed.) Vol. 31; no. 11; pp. 654 - 663
• Main Authors: Zhao, Qinjian, Li, Shaowei, Yu, Hai, Xia, Ningshao, Modis, Yorgo
• Format: Journal Article
• Language: English
• Published: Cambridge, MA Elsevier Ltd 01.11.2013; Cell Press; Elsevier Limited
• Subjects: Biological and medical sciences; bionanoparticle; bioprocessing; Biotechnology; comparability exercise; epitope mapping; epitopes; functional properties; Fundamental and applied biological sciences. Psychology; Hepatitis; Hepatitis B Vaccines - isolation & purification; Hepatitis B Vaccines - pharmacology; Hepatitis B virus; Hepatitis E virus; Human papillomavirus; Humans; Infections; Internal Medicine; Lipids; neutralizing antibody; Orthohepevirus A; Papillomaviridae; Papillomavirus Vaccines - isolation & purification; Papillomavirus Vaccines - pharmacology; patients; Physical properties; potency assay; subunit vaccine; Technology, Pharmaceutical - methods; Vaccine Potency; Vaccines; Vaccines, Synthetic - isolation & purification; Vaccines, Synthetic - pharmacology; Vaccines, Virus-Like Particle - isolation & purification; Vaccines, Virus-Like Particle - pharmacology; Vaccines, Virus-Like Particle - ultrastructure; Viral Hepatitis Vaccines - isolation & purification; Viral Hepatitis Vaccines - pharmacology; virion; virus-like particle vaccines; virus-like particles; viruses; Yeast; United States > US; bionanoparticle; neutralizing antibody; subunit vaccine; comparability exercise; epitope mapping; potency assay; Human; Vaccine; Virus like particle; Quality
• ISSN: 0167-7799; 1879-3096; 1879-3096
• DOI: 10.1016/j.tibtech.2013.09.002

•Human vaccines against three viruses employ recombinant virus-like particles (VLPs).•VLPs are excellent vaccine antigens because they faithfully mimic the native virions.•Post-purification reassembly of VLPs can improve antigenicity and vaccine efficacy.•Critical quality attributes of VLPs are assessed to guide vaccine production. Human vaccines against three viruses use recombinant virus-like particles (VLPs) as the antigen: hepatitis B virus, human papillomavirus, and hepatitis E virus. VLPs are excellent prophylactic vaccine antigens because they are self-assembling bionanoparticles (20 to 60nm in diameter) that expose multiple epitopes on their surface and faithfully mimic the native virions. Here we summarize the long journey of these vaccines from bench to patients. The physical properties and structural features of each recombinant VLP vaccine are described. With the recent licensure of Hecolin against hepatitis E virus adding a third disease indication to prophylactic VLP-based vaccines, we review how the crucial quality attributes of VLP-based human vaccines against all three disease indications were assessed, controlled, and improved during bioprocessing through an array of structural and functional analyses.