Novartis Ag

Seqirus UK Limited

Other

Novartis Vaccines & Diagnostics, Gmbh

Jens-Peter Gregersen

Holger Kost

Holger Lübben

Jürgen Vorlop

Christian Frech

Holger Luebben

Juergen Vorlop

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 &#x3b2;-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.

Cell-derived viral vaccines with low levels of residual cell DNA

Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modern 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.

Decreasing potential iatrogenic risks associated with influenza vaccines

The present invention concerns a method for production of an active ingredient of a drug or diagnostic agent, in which The invention also concerns a method for production of a drug or diagnostic agent in which an active ingredient is produced according to the above method and mixed with an appropriate adjuvant, auxiliary, buffer, diluent or drug carrier.

Methods for producing an active constituent of a pharmaceutical or a diagnostic agent in an MDCK cell suspension culture

Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modern techniques grow the virus in mammalian cell culture e.g. on Vero, MDCK or PER.C6 cell lines. The inventor has realized 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.

Decreasing potential iatrogenic risks associated with vaccines and vaccine antigens

Influenza viruses for use in preparing human vaccines have traditionally been grown on embryonated hen eggs, although more modern techniques grow the virus in mammalian cell culture e.g. on Vero, MDCK or PER.C6 cell lines. The inventor has realized that the conditions used for influenza virus 5 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.

Growing community of inventors

Marburg, Germany

Jens-Peter Gregersen