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GEN News Highlights : Sep 29, 2006

FDA Issues Guidance for Cell-Based Viral Vaccines

Recommendations designed to help manufacturers develop new and better vaccines and boost production capacity.

The FDA issued new guidance regarding development of safe and effective cell-based viral vaccines. The 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 is a vital part of our overall efforts to help manufacturers develop new vaccines that are critical to meeting global public health needs,” asserts acting FDA commissioner, Andrew von Eschenbach, M.D.

The public has 90 days to comment on the draft document. When finalized, the guidance will represent the FDA’s current thinking on this topic. The current document, “Guidance for Industry: Characterization & Qualification of Cell Substrates & Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention & Treatment of Infectious Diseases,” is now availble.

Through this 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.” It presents information for determining the suitability of a cell culture for manufacturing, plus testing and validating the safety/purity of the cells used in developing and producing 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, says the FDA.

“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,” says Jesse Goodman, M.D., director, Center for Biologics Evaluation & 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.”