Quality aspects on the isolation of candidate influenza vaccine viruses in cell culture - Scientific guideline

This document provides guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine
manufacture. The quality requirements of this guideline have been replaced by the guideline on influenza vaccines - quality module.

Keywords: Candidate vaccine virus, cell culture, isolation, quality recommendations, influenza

Current effective version

Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture

Adopted Reference Number: EMA/CHMP/BWP/368186/2011 Summary:

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.

Document history - First version (current)

Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture

Adopted Reference Number: EMA/CHMP/BWP/368186/2011 Summary:

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.

Overview of comments received on 'Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture'

Adopted Reference Number: EMA/CHMP/BWP/453628/2011

Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture

Draft: consultation closed Consultation dates: 20/05/2010 to 01/09/2010 Reference Number: EMA/CHMP/BWP/68803/2010

Concept paper on the need to update the current annex guideline on cell culture inactivated influenza vaccines with respect to the derivation of cell-isolated influenza vaccine viruses

Reference Number: EMEA/CHMP/BWP/481473/2008