发明授权
- 专利标题: IMPROVED METHODS FOR THE PRODUCTION OF NON-COVALENTLY COMPLEXED AND MULTIVALENT PROTEOSOME SUB-UNIT VACCINES
- 专利标题(中): 改进的方法生产非共价复合的多价疫苗反对蛋白酶体亚基
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申请号: EP96932269.2申请日: 1996-09-18
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公开(公告)号: EP0854729B1公开(公告)日: 2004-03-10
- 发明人: LOWELL, George, H. , ZOLLINGER, Wendell, D. , WOOD, James, F.
- 申请人: United States Army Medical Research Materiel Command (USAMRMC) , ID Biomedical Corporation of Quebec
- 申请人地址: MCMR-JA- John F. Moran, Ft. Detrick Frederick, MD 21702-5012 US
- 专利权人: United States Army Medical Research Materiel Command (USAMRMC),ID Biomedical Corporation of Quebec
- 当前专利权人: United States Army Medical Research Materiel Command (USAMRMC),ID Biomedical Corporation of Quebec
- 当前专利权人地址: MCMR-JA- John F. Moran, Ft. Detrick Frederick, MD 21702-5012 US
- 代理机构: Goldin, Douglas Michael
- 优先权: US003859P 19950918
- 国际公布: WO1997010844 19970327
- 主分类号: A61K39/385
- IPC分类号: A61K39/385 ; A61K39/116 ; A61K39/02 ; A61K39/095 ; C07K1/00 ; A23J1/00 ; C12N1/00 ; A61K39/112
摘要:
A continuous method for preparing proteosome-amphiphilic determinant vaccines for parenteral or mucosal administration using diafiltration or ultrafiltration technology. The amphiphilic determinants include lipopolysaccharides from gram negative bacteria, e.g. S. flexneri, P. shigelloides and S. sonnei. Proteosomes are obtained from group B type 2b meningococci. The active proteosome-amphiphilic determinant complexes (non-covalent complexes) of the vaccine are formed using diafiltration or ultrafiltration to remove the detergent under non-static conditions. The use of diafiltration or ultrafiltration decreases processing time and the opportunity for contamination and further permits the use of ambient temperature and efficient scale-up. In addition, the process permits the reliable and continuous monitoring of the dializate which enhances the efficiency of the entire process. The time of dialysis for the production of a lot of vaccine is reduced from 7-10 days to less than 72 hours and usually less than 48 or 24 hours. The use of the process optimizes the presence of each antigenic component in the preparation of multivalent vaccines.
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