FDAnews
www.fdanews.com/articles/62813-sanofi-pasteur-begins-study-of-cell-based-flu-vaccine

SANOFI PASTEUR BEGINS STUDY OF CELL-BASED FLU VACCINE

September 26, 2006

Sanofi pasteur has initiated its first clinical study of a new generation of seasonal influenza vaccine produced using the PER.C6 cell-culture technology of Dutch biotechnology company Crucell. This trial represents one of sanofi pasteur's initiatives to diversify flu vaccine manufacturing technologies.

The trial is being conducted in the United States is part of a contract awarded by the U.S. Department of Health and Human Services to accelerate the development of a new cell- based influenza vaccine. The Phase I clinical trial will be conducted on 100 healthy adults, 18 to 64 years of age. Half of the study participants will receive the cell-based vaccine and the other half a traditional egg-based control vaccine.

This vaccine was developed using PER.C6 cell-culture technology, which could allow sanofi pasteur to reduce dependence on eggs while offering an additional reliable production technology. The production scale potential of the PER.C6 cell line has been demonstrated in a successful bioreactor run of 20,000 liters. This project breaks new ground in vaccines technology by demonstrating effective large-scale production capacity using cell culture on a commercial scale.