Development of Vero Cell-Derived Inactivated Japanese Encephalitis Vaccine

• Published in: Biologicals Vol. 30; no. 4; pp. 303 - 314
• Main Authors: Sugawara, Keishin, Nishiyama, Kiyoto, Ishikawa, Yuji, Abe, Motoharu, Sonoda, Kengo, Komatsu, Kazuhiro, Horikawa, Yoshikane, Takeda, Kengo, Honda, Tomitaka, Kuzuhara, Shoji, Kino, Yoichiro, Mizokami, Hiroshi, Mizuno, Kyosuke, Oka, Tetsuya, Honda, Kennosuke
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.2002
• Subjects: Animals; Antigens, Viral - analysis; Cercopithecus aethiops; Encephalitis Virus, Japanese - immunology; Encephalitis Virus, Japanese - isolation & purification; Encephalitis Virus, Japanese - ultrastructure; Enzyme-Linked Immunosorbent Assay; Fermentation; Japanese encephalitis vaccine, Vero cell, microcarrier; Japanese Encephalitis Vaccines - immunology; Japanese Encephalitis Vaccines - isolation & purification; Mice; Microscopy, Electron; Neutralization Tests; Safety; Vaccines, Inactivated - immunology; Vaccines, Inactivated - isolation & purification; Vero Cells; Virus Cultivation; Japanese encephalitis vaccine, Vero cell, microcarrier
• ISSN: 1045-1056; 1095-8320
• DOI: 10.1006/biol.2002.0345

We have established a manufacturing system for a Vero cell-derived inactivated Japanese encephalitis vaccine at a 500 l scale. The production system involves expansion of Vero cells using microcarrier, followed by virus infection. Except for an additional purification step, the downstream purification processes are similar to those used for the current mouse brain-derived vaccine; cell removal, concentration and removal of low-molecular weight impurities by membrane filtration, formalin-inactivation, sucrose density gradient ultracentrifugation, and Sulfate-Cellulofine column chromatography are conducted. The antigen obtained from the manufacturing system was highly purified and its physico-chemical and immunological properties were comparable with those of antigen derived from mouse brains. Our system is very simple and could be easily scaled-up to allow vaccine production at a several thousand litre scale. Copyright 2002 The International Association for Biologicals. Published by Elsevier Science Ltd. All rights reserved.