FDA issues guide to ease production of cell-based vaccines

Oct 2, 2006 (CIDRAP News) – In a major push to modernize and speed the production of vaccines for pandemic influenza and other emerging threats, the US Food and Drug Administration (FDA) last week issued new guidance on how to safely and effectively develop new cell-based vaccines.

The document, released Sep 28, updates 13-year-old guidelines on cell culture manufacturing, currently used to make vaccines for other diseases such as measles, mumps, and polio, according to an FDA press release.

The currently used egg-based method of producing influenza vaccines hasn't changed much in 50 years and is more laborious than cell culture production techniques. To produce a vaccine, the virus strain must be adapted to grow in eggs, and huge quantities of special fertilized eggs must be available.

With cell culture technology, manufacturers grow vaccine components in human or animal cells so the viruses don't need to be adapted. Cells can be frozen and stored for use when needed, allowing production to be quickly ramped up in the event of an emergency.

"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," said Jesse Goodman, MD, MPH, in the press release. Goodman directs the FDA Center for Biologics Evaluation and Research.

The guidance helps vaccine makers determine the suitability of a cell culture for manufacturing, as well as test and validate the safety and purity of the cells. The document also advises when to test at different stages of production and defines quality-control testing methods for cell substrate and adventitious agents.

The US Department of Health and Human Services (HHS) has made cell-based vaccine manufacturing a central focus of its pandemic plan. In May it awarded $1 billion among five companies to develop cell-based technologies for making flu vaccines.

In April 2005, HHS awarded Sanofi Pasteur a $97 million contract to develop a cell-based flu vaccine. The company was the first to receive a federal contract for commercial-scale use of new flu vaccine technology.

Last week, Sanofi Pasteur announced the launch of the first clinical trial of its first seasonal influenza vaccine made using cell culture technology.

See also:


May 4 CIDRAP News article "US awards $1 billion for cell-based flu vaccines"

Jun 27, 2005, CIDRAP News article "Momentum builds for cell-culture flu vaccines"

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