Patent application title: DECREASING POTENTIAL IATROGENIC RISKS ASSOCIATED WITH INFLUENZA VACCINES

Inventors: Jens-Peter Gregersen
Agents: NOVARTIS VACCINES AND DIAGNOSTICS INC.
Assignees: CHIRON BEHRING GMBH & CO.
Origin: EMERYVILLE, CA US
IPC8 Class: AA61K3900FI
USPC Class: 4242061

Abstract:

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 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.

Claims:

1. A process for preparing an influenza vaccine from influenza virus that has been grown in a culture of a mammalian cell line, comprising a step in which the vaccine and/or the culture is tested for the presence of an infectious agent that can grow in said cell line but that does not grow in embryonated hen eggs.

2. A process for preparing an influenza vaccine from influenza virus that has been grown in a culture of a mammalian cell line, comprising a step in which the vaccine and/or the culture is treated to remove and/or inactivate an infectious agent that can grow in the cell line but does not grow in embryonated hen eggs.

3. The process of claim 1 or claim 2, wherein the mammalian cell line is a MDCK cell line, a Vero cell line, or a PER.C6 cell line.

4. The process of any preceding claim, wherein the infectious agent is selected from the group consisting of: Pneumovirinae; Morbilliiviruses of the Paramyxoviridae family; Enteroviruses of the Picornaviridae family; mammalian Reoviridae; and Birnaviridae.

5. The process of claim 4, wherein the infectious agent is selected from the group consisting of: respiratory syncytial virus; measles virus; Coxsackie viruses; echoviruses; enteroviruses; orthoreoviruses; rotaviruses; and infectious bursal disease virus.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.