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Published on 9/26/2006 in the Prospect News Biotech Daily.

Sanofi-Aventis starts cell culture-based seasonal flu vaccine trial

By E. Janene Geiss

Philadelphia, Sept. 26 - Sanofi Pasteur, the vaccines business of the Sanofi-Aventis group, said it started its first clinical study Tuesday with a new generation of seasonal influenza vaccine produced using cell culture technology.

This trial represents one of the company's initiatives to diversify flu vaccine manufacturing technologies, the Lyon, France, pharmaceutical company said in a news release.

The trial will be conducted in the United States and is part of a contract awarded by the U.S. Department of Health and Human Services to accelerate the development of a new cell culture-based influenza vaccine.

The study is the first step toward filing a Biologics License Application with the Food and Drug Administration to support development of a cell culture-based trivalent split inactivated seasonal influenza vaccine.

This vaccine was developed using PER.C6 cell culture technology, licensed from Leiden, the Netherlands-based Crucell NV. Cell culture technology could allow Sanofi to diminish dependence on eggs while offering a reliable production technology.


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