"The guidance document ( Cell_Based_Vaccines_Guidance_Doc )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," said Acting Commissioner Andrew von Eschenbach, M.D., Food and Drugs. "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, 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.
