The FDA said in a statement that its goal is to facilitate the development and availability of safe and effective vaccines, including those to address emerging and pandemic threats.
Acting Commissioner Andrew von Eschenbach, M.D., Food and Drug, said in the release, "The guidance document released today is a vital part of our overall efforts to help manufacturers develop new vaccines that are critical to meeting global public health needs."
He added, "This guidance promises to help modernize the development of life-saving vaccines for influenza and other diseases and facilitate the development of more plentiful, reliable supplies."
In the guidance, the FDA provides manufacturers of viral vaccines with updated recommendations to the 1993 document "Points to Consider in the Characterization of Cell Lines Used to Produce Biologics."
The updated guidance conveys information for determining the suitability of a cell culture for manufacturing, as well as testing and validating the safety and purity of the cells used in the development and production of viral vaccines.
It also provides information on testing at different stages of production and quality-control test methods for cell substrate and adventitious agent issues.
According to the FDA, cell cultures are used to produce licensed vaccines that help protect against diseases such as measles, mumps and polio.
The agency said cell-based vaccine manufacturing holds the promise of a reliable and flexible alternate method of producing influenza vaccines.
Current vaccines are produced in chicken eggs by a technique developed more than 50 years ago.
