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Cell-based Viral Vaccines: FDA Issues Final Guidance
Vaccine
Market
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.
posted: 3/4/2010
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