FDA RELEASES GUIDANCE ON DEVELOPING PANDEMIC VACCINES

The FDA issued a new guidance Sept. 28 to help makers of cell-based viral vaccines improve the development and availability of vaccines, including those to address emerging and pandemic threats.

As demands for influenza vaccine and threats of infectious diseases, such as SARS, increase, increased flexibility is needed to allow surge capacity in an emergency, the agency said. Cell-based vaccine manufacturing provides this flexibility — allowing cells to be frozen for storage and then thawed as needed to produce more vaccine.

The guidance, "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," offers advice on using cell cultures and modern technology to ensure that these vaccines meet the highest safety expectations.

The new guidance replaces the 1993 document, "Points to Consider in the Characterization of Cell Lines Used to Produce Biologics." The updates include information on:

• Determining the suitability of a cell culture for manufacturing;
• Testing and validating the safety and purity of cells used in the development and production of viral vaccines;
• Testing at different stages of production; and
• Quality-control test methods for cell substrate and adventitious agent tissues.

Cell-based vaccines could provide a reliable and flexible method for manufacturing influenza vaccines, which are currently produced in chicken eggs using a 50-year-old technique, said the agency.