To boost development of cell-based viral vaccines FDA issued final guidance. Today’s guidance outlines the best practices using current and emerging science to safely expand the types of cells that may be used to produce vaccines.
According to a recent market study “Global Pandemic Influenza Preparedness Market Forecast 2010-2015“, cell-based development will be the core of the intermediate and long-term pandemic influenza preparedness strategy for larger, more flexible, and less vulnerable manufacturing surge capacity for production of seasonal and pandemic influenza vaccines. Cell-based production capability provides unprecedented manufacturing flexibility. The transition from egg-based to cell-based production sets the stage for the development of next generation vaccines. Recombinant and universal influenza vaccines will almost inevitably be produced in cell culture facilities, not in living, embryonated eggs fresh from the farm.
The new document Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications will help manufacturers developing safe and effective cell-based viral vaccines to address emerging and pandemic threats, such as for influenza vaccines.
Currently, all licensed influenza vaccines are produced in chicken eggs. Cell cultures are now used to produce licensed vaccines that help protect against diseases such as rubella and polio.
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