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The U.S. Food and Drug Administration (FDA) today issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines. FDA's goal is to facilitate the development and availability of safe and effective vaccines, including those to address emerging and pandemic threats.
"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," 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.
Cell cultures are used to produce licensed vaccines that help protect against diseases such as measles, mumps and polio. Today's guidance outlines the best practices using current and emerging science.
Cell-based vaccine manufacturing holds the promise of a reliable and flexible alternate method of producing influenza vaccines, which are currently produced in chicken eggs by a technique developed more than 50 years ago.
With increasing demand for seasonal influenza vaccine and with the potential threat of a pandemic, as well as other emerging infectious diseases (for example, SARS), more flexible approaches that allow surge capacity in an emergency are critical. With cell-based manufacturing, cells can be frozen and stored and thawed as needed to produce more vaccine.
"This guidance document provides important advice for manufacturers on using cell cultures to produce needed vaccines against infectious diseases and to use modern technologies to assure that they meet the highest safety expectations," said Jesse Goodman, M.D., M.P.H., director, Center for Biologics Evaluation and Research, FDA. "The advice will assist manufacturers, including those that make influenza vaccine, both to develop new and better vaccines and to boost production capacity, making us better prepared for the threat of a future influenza pandemic and other infectious diseases."
A copy of the guidance, "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases," is available at: www.fda.gov/cber/gdlns/vaccsubstrates.pdf. The public has 90 days to comment on the draft document. When finalized, the guidance will represent FDA's current thinking on this topic.
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