Isolation of Candidate Influenza Vaccine Viruses in Cell Culture

This Guideline lays down the quality recommendations for cells used to isolate candidate influenza vaccine viruses, the conditions under which the viruses are isolated and the subsequent passage of the viruses until the manufacturer's Master Seed is prepared under GMP conditions. This guideline replaces its draft version published under document reference EMA/CHMP/BWP/68803/2010. It should be read in conjunction with other relevant guideline documents like the introduction and general principles (4) and Part 1 of the Annex I to Directive 2001/83 or referneces like Ph. Eur. General chapter 5.2.3.

Get more information in the "Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture".

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