CPMP's flu guidelines

Published: 1-Apr-2003


Informal guidelines have been drawn up by EMEA's Committee for Proprietary Medicinal Products on the production of live attenuated influenza vaccines.

In an introduction to the note, the committee says that existing inactivated flu vaccine guidelines do not address the requirements of producing these live medicines 'in embryonated eggs based on cold-adapted influenza virus master strains'.

As a result, the paper suggests that 'storage conditions of seed lots should be validated with respect to infectivity, genetic stability and sterility.'

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