The characterization of cell substrates, virus seed stocks and virus harvests, used in human vaccine production, for identity and purity is required by regulators worldwide. This presentation will give you an overview of the regulatory requirements given in the latest guidance documents from the US FDA, WHO, European Pharmacopoeia and ICH. It will highlight differences between these documents and describe new technologies for determining the identity of cell substrates and virus seed stocks as well as detecting adventitious agent contamination.
In this webinar, you will learn:
- about the importance of characterising cell banks and virus seed stocks in order to meet worldwide regulatory requirements.
- the difference between guidance documents from different organizations worldwide
- new technologies for determining the identity of cell substrates and virus seed stocks
- detecting adventitious agent contamination