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Presentation: Viral contamination and continuous quality and safety of cell line produced vaccines

Dr Isabelle Sainte-Marie, Head of the Viral Safety Unit, AFSSAPS joined us at the World Vaccine Congress in Washington in 2012 to discuss viral contamination and continuous quality and safety of cell line produced vaccines.
 
There are, of course, core principles of viral safety. Despite this, it is very important that a risk assessment is carried out, in which a variety of factors should be taken into account:

• species of origin
• nature of organ, tissue, fluid
• potential contaminants from raw material, etc.
• potential contaminants from manufacturing process (reagents, handling)
• Controls carried out (on raw material, during production…)
• virus inactivation/removal during manufacture
• Infectivity and pathogenicity of potential contaminants
• route of administration of medicinal product.
• amount of starting material to produce a dose

Important in the consideration of the risks of any vaccine development is the potential sources of contamination: Cell substrates and virus sees, Raw materials and Environmental contamination.

Within viral safety there are several methods available for testing: in vitro, in vivo, retroviruses and more specific tests depending on the origin of the cells and raw materials used.  Dr Sainte-Marie discussed the limitation of general methods within this presentation.
To finish, this presentation concludes on the development of novel screening systems and viral safety of cell substrates vaccines.
 

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