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Presentation: Developing a Scientifically Guided, Risk-Based Virus Safety Concept for a Cell-Derived Vaccine

 
 
 
 
 
 
 
 
 
 
 
 
Dr Jens-Peter Gregersen, Technology Development, Virus Safety and New Projects, Novartis Vaccines & Diagnostics joined us at the World Vaccine Congress earlier this year in Washington. To open, he began by asking: what is a scientifically guided, risk based concept?
 
Scientifically guided
·         Scientific data where possible and reasonable
·         Judgements or decisions are reproducible and well-founded
Risk-based
·         Risks identified and prioritized or rated by criticality
·         Concentration on relevant risks
Concept
·         Comprehensive
·         Forward-looking and proactive
 
The development of a viral safety concept has five stages, each of which is detailed within this presentation.
 
Why not download the full presentation and find out more about developing a scientifically guided, risk based viral safety concept for a cell-derived vaccine:
·         How do you get objective data for unknown contamination events?
·         How do you adequately assess the risks for hundreds of potential adventitious agent contaminants?
·         What are the limiting factors for virus inactivation and virus removal and how can they be overcome?

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