期刊
TRENDS IN BIOTECHNOLOGY
卷 31, 期 11, 页码 654-663出版社
ELSEVIER SCIENCE LONDON
DOI: 10.1016/j.tibtech.2013.09.002
关键词
subunit vaccine; comparability exercise; potency assay; bionanoparticle; epitope mapping; neutralizing antibody
资金
- Institute Reconstruction Fund [2011FU125Z04]
- National science Foundation of China [81172885, 81273327]
- Xiamen City Municipal platform fund on viral biotherapeutics [3502Z20131001]
- Burroughs Wellcome Investigator Award
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 60 nm 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.
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