The risk of viral contamination is a feature common to all biotechnological products derived from human or animal plasma and mammalian cell lines. Safety concepts have to guarantee the absence of endogeneous and adventitious viral contaminants. Cell line characterization, raw material testing as well as a validated concept for the elimination of any potential viral contaminants within the production itself are necessary elements to ensure viral safety.
Target Group
Staff working in areas from production, quality control and product|method development with interest in the viral safety of biologicals.
Topics in seminars and discussion forums include:
* Virus Safety for Biologicals: Regulatory Requirements|Guidelines * Virus Inactivation and Removal Technologies:New Methods and Current Trends * Methods for detecting Viral Contaminants * Validation of Virus Removal and Inactivation * Current Perspective | Experience Reports on Virus Validation Studies * Methods and Models for TSE Removal and Inactivation | Methods for Detection * TSE Validation Studies
Workshop
Design of a Virus Clearance Study for a CHO cell derived process
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