ICH guidelines and PhEur monographs on derivation and characterisation of cell substrates used for production of biotechnological/biological products. International Conference on Harmonisation.

ABSTRACT

This presentation gives an overview of the guidance which is available in the EU as it would be applicable to licensing requirements for influenza vaccines produced on banked cells. Whereas ensuring compliance of cell banks would be relatively straightforward, ensuring compliance of new virus seeds (and possibly harvests) with requirements concerning adventitious viral contamination needs further evaluation.