October 9, 2006

FDA issues new guidelines for cell-based vaccine manufacturers

The FDA last week issued new guidelines on the use of cell-cultured vaccines to replace the age-old method of cultivating vaccines through chicken eggs.

FDA's guidelines, the first update in 13 years, are aimed at all manufacturers, explaining options for ensuring the safety and purity of different cell-culture types.

Cell-based vaccines are derived from human or animal cells.

The US government has granted millions for cell-culture research as it is deemed to be a faster way of manufacturing vaccines than the traditional way.

Sanofi Pasteur spokesman Len Lavenda, whose company entered a five-year government contract last year to speed development of cell-based flu shots, welcomed the news, saying that manufacturers should know about the FDA's licensure process early in the development process.

Sanofi, the leading flu-shot maker in the US, also opened its first safety study of a cell-based influenza vaccine.

Egg-based flu vaccines requires growing the flu virus inside tens of millions of eggs from specially raised hens, taking months in the process. On the other hand, a cell-based system can guarantee faster production if a new flu strain suddenly appeared as there are fewer limitations on cell numbers than eggs.