Regulation protects us: be it from food poisoning from a restaurant or from dangerous vaccines. It is a part of everyday business.
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 productionâ¦)
- 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.
One of the major questions of this presentation: is the ideal of viral safety possible and realistic? Tell us your views below!
Why not download the full presentation and discover more about Viral contamination and continuous quality and safety of cell line produced vaccines:
- Learning from large and small scale contaminations the importance of whole chain screening in the identification and subsequent prevention of contamination.
- Can the strategies that are employed during such events be improved for future application?
- Will the continuous quality and safety of cell line produced vaccines be achieved or is identification of contamination the best we can hope for?