|Effective Viral Contamination Testing Programs for Biologics Product Manufacturing|
Tuesday, May 20, 2014 – 11 am EDT and Tuesday, May 27, 2014 – 11:00 CET
By registering for this webcast you will also receive a valuable whitepaper after the live broadcast, which provides a detailed summary of the session.
Viruses pose a threat at all stages of the biopharmaceutical manufacturing process from raw materials, to cell lines and cell culture, through bulk harvests and biomanufacturing. Biopharmaceutical manufacturers need comprehensive virus testing programs to ensure product safety throughout the various manufacturing stages.
In this webcast, experts will describe strategies and best practices for developing and implementing effective virus testing programs, including a review of regulatory guidance. In addition, participants will learn about test methods for virus detection and quantitation during various biopharmaceutical manufacturing phases. A range of testing technologies, including in vitro adventitious virus assays, PCR, ELISA, plaque assays, and electron microscopy, as well as sampling methods, will be discussed.
The panelists will provide an analysis of the advantages and limitations of each method, as well as methods that are most suitable for specific situations.
Key Learning Objectives:
• Develop a comprehensive plan for effective testing for viral contaminants
• Review current testing methods and revise current methods to ensure product safety
• Understand pros and cons for various methods for detecting viruses
Scientific Operations Director
Euan W. Milne
SGS Life Science Services
Paul Regulatory Consulting Services
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