The US Food and Drug Administration (FDA) has issued final guidance to help manufacturers develop cell-based viral vaccines to address emerging and pandemic threats such as new influenza strains.

FDA scientists spent more than a decade conducting research that will help with the production of cell culture-based vaccines, which have in the past been successfully used to protect against diseases such as rubella and polio.

Titled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,” the document will aid manufacturers who wish to use new cell substrates for vaccine production.

Currently, all licensed influenza vaccines are produced in chicken eggs.

FDA commissioner Margaret Hamburg, MD, said that the availability of this final guidance is an important tool to help manufacturers advance the development and production of cell-based vaccines.

In addition to providing advice to manufacturers about the scientific principles of cell substrate development, the guidance describes tests that may be used to evaluate cell substrates intended for use in viral vaccine production.