摘要:
Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modem techniques grow the virus in mammalian cell culture e . g . on Vero, MDCK or PER.C6 cell lines. The inventor has realised that the conditions used for influenza virus culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections.
摘要翻译:用于制备人类疫苗的流感病毒传统上已经在含胚的鸡蛋上生长,尽管更多的现代技术在哺乳动物细胞培养物中生长病毒e。 G 。 在Vero,MDCK或PER.C6细胞系上。 发明人认识到,用于流感病毒培养的条件可增加除流感病毒以外的病原体可能在细胞系中生长并识别特定污染风险的风险。 因此,在制造过程中可以进行合适的测试,以确保安全性并避免医源性感染。
摘要:
The present invention relates to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as β-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.
摘要:
A fermenter for use in biotechnical processes in particular for culturing cells is disclosed. The object, to provide a fermenter vessel (1) the inner volume of which can be optically monitored and which fermenter vessel can also be efficiently sterilized is achieved by a fermenter vessel (1) having an outside wall (2) enclosing a vessel volume with a view port (7) being provided in the outside wall (2) for inspecting processes within the vessel volume, the view port (7) having a transparent member (8) wherein the transparent member (8) is provided with a heating device.
摘要:
Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modem techniques grow the virus in mammalian cell culture e . g . on Vero, MDCK or PER.C6 cell lines. The inventor has realised that the conditions used for influenza virus culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections.
摘要:
Various improvements to vaccines that include a serogroup C meningococcal conjugate antigen, including: (a) co-administration with acellular B.pertussis antigen; (b) co-administration with an inactivated poliovirus antigen; (c) supply in a kit together with a separate pneumococcal conjugate component, which may be in a liquid form; and (d) use in combination with a pneumococcal conjugate antigen but without an aluminium phosphate adjuvant. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae; and (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C.
摘要:
Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modem techniques grow the virus in mammalian cell culture e . g . on Vero, MDCK or PER.C6 cell lines. The inventor has realised that the conditions used for influenza virus culture can increase the risk that pathogens other than influenza virus may grow in the cell lines and have identified specific contamination risks. Suitable tests can thus be performed during manufacture in order to ensure safety and avoid iatrogenic infections.
摘要:
Antigens from individual influenza virus strains are not refrigerated before being combined to make multivalent influenza virus vaccines. Moreover, influenza vaccines are not refrigerated between packaging and administration. Thus the need for refrigeration is minimized, and the cold-chain does not have to be maintained between vaccine manufacture and administration.
摘要:
A scrogroup C meningococcal conjugate antigen which is free from aluminium phosphate is co-administered with a pneumococcal saccharide conjugate which may be in a liquid form. A kit may have: (a) a first immunogenic component that comprises an aqueous formulation of a conjugated capsular saccharide from Streptococcus pneumoniae ; and (b) a second immunogenic component that comprises a conjugated capsular saccharide from Neisseria meningitidis serogroup C and is free from aluminium phosphate.
摘要:
The present invention relates to vaccine products for the treatment or prevention of viral infections. Further provided are methods of reducing contaminants associated with the preparation of cell culture vaccines. Residual functional cell culture DNA is degraded by treatment with a DNA alkylating agent, such as β-propiolactone (BPL), thereby providing a vaccine comprising immunogenic proteins derived from a virus propagated on cell culture, substantially free of residual functional cell culture DNA.