Robust manufacturing and comprehensive characterization of recombinant hepatitis E virus-like particles in Hecolin

Highlights • Recombinant capsid protein of hepatitis E virus as vaccine antigen. • Multiple epitope characterization using monoclonal antibodies. • Successful scale up and robust manufacturing of vaccine antigen. • Product consistency demonstrated with orthogonal analytical methods. • In-depth chara...

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Veröffentlicht in:	Vaccine 2014-07, Vol.32 (32), p.4039-4050
Hauptverfasser:	Zhang, Xiao, Wei, Minxi, Pan, Huirong, Lin, Zhijie, Wang, Kaihang, Weng, Zusen, Zhu, Yibin, Xin, Lu, Zhang, Jun, Li, Shaowei, Xia, Ningshao, Zhao, Qinjian
Format:	Artikel
Sprache:	eng
Schlagworte:	Allergy and Immunology Animals Antibodies, Monoclonal, Murine-Derived - immunology Antigens Antigens, Viral - immunology Applied microbiology Biological and medical sciences Calorimetry Capsid protein Capsid Proteins - immunology Epitopes - immunology Female Fundamental and applied biological sciences. Psychology Genomes Heat tolerance Hepatitis Hepatitis E virus Human papillomavirus Methods Mice, Inbred BALB C Microbiology Miscellaneous Molecular Weight Mortality Particle Size Peptides Product consistency Proteins Recombinant vaccine Vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Synthetic - biosynthesis Vaccines, Synthetic - standards Vaccines, Virus-Like Particle - biosynthesis Vaccines, Virus-Like Particle - standards Viral Hepatitis Vaccines - biosynthesis Viral Hepatitis Vaccines - standards Viral infections Virology Virus-like particle
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Beschreibung
Zusammenfassung:	Highlights • Recombinant capsid protein of hepatitis E virus as vaccine antigen. • Multiple epitope characterization using monoclonal antibodies. • Successful scale up and robust manufacturing of vaccine antigen. • Product consistency demonstrated with orthogonal analytical methods. • In-depth characterization of recombinant virus-like particles.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2014.05.064