  The US Food and Drug Administration (FDA) issued a new  guidance September 28 to help manufacturers develop safe and effective  cell-based viral vaccines. FDA's goal is to facilitate the development of  vaccines, including those to address emerging and pandemic threats.

  Entitled "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," the  guidance updates recommendations in the 1993 document, "Points to Consider in  the Characterization of Cell Lines Used to Produce Biologics."

  The updated guidance provides information for determining  the suitability of a cell culture for manufacturing, as well as for testing and  validating the safety and purity of the cells used to develop and produce viral  vaccines. It also provides information on testing at different production  stages, and describes quality-control test methods for cell substrate and  adventitious agent issues.

“This is a propitious time for a new guidance,” says Philip  Krause, MD, Deputy Director of the Division of Viral Products of the Office of  Vaccines. 

”There has been an expansion of the kinds of cells manufacturers  are considering for use in vaccine manufacture, and there have also been  improvements in the technology for testing cells,” he says.

  The new document is timely for another reason, too. Demands  for influenza vaccine will surely be rising, as flu season approaches; it is  easier to scale up cell-based vaccines, than it is egg-based vaccines, if and  when surge capacity is needed. Cells, unlike eggs, can be frozen for staroage  and then thawed when needed.

  Unlike the previous document, according to Krause, the new  guidance offers a lot of scientific rationale for recommendations and provides  the underlying principles for why they are made. This helps manufacturers think  about how to address issues associated with cells used in vaccine manufacture. 

  Basically, says Krause, it compiles into one place  long-standing methods and recommendations about vaccine development. The  guidance is available at: 

www.fda.gov/cber/gdlns/vaccsubstrates.pdf

News

The US Food and Drug Administration (FDA) issued a new guidance September 28 to help manufacturers develop safe and effective cell-based viral vaccines.