Viral Safety for BioLogics
Excelsior Hotel Ernst,
Trankgasse 1-5 / Domplatz,
Cologne,, Germany
Keywords: Viral Safety for BioLogics, Informa Life Sciences, Excelsior Hotel Ernst,

Schedule of Presentations:

Tuesday, June 23, 2009
08:00:00 Registration and morning coffee
09:00:00 Chairperson’s opening remarks
09:05:00 Adventitious virus testing: from anecdote to evidence Thomas R. Kreil
09:45:00 Adventitious virus testing of cell lines and unprocessed bulk Michael Ruffing
10:25:00 Morning coffee and exhibition viewing time
10:55:00 Regulatory update on the “Guideline on Virus Safety Evaluation of Biotechnology Investigational Medicinal Products” Albert Stühler
11:35:00 Quality attributes of virus spike preparations used in virus clearance studies
12:15:00 Discussion forum
12:30:00 Spotlight presentation
13:00:00 Lunch and exhibition viewing time
14:00:00 New and rapid methods to detect viral contaminants Ranga Sampath
15:20:00 Afternoon tea and exhibition viewing time
15:40:00 GMPviral detection by qPCR: how to achieve speed, reliability, Health Authority approval and automation in a high-tech environment Emiliano Toso
16:30:00 Detergent Inactivation as a robust viral clearance step Bin Yang
17:10:00 End of Day One followed by welcome John Kolman
Wednesday, June 24, 2009
08:30:00 Morning coffee David P. Davis
09:00:00 Chairperson’s opening remarks
09:05:00 Emerging viruses and strategies to combat them Albrecht Groner
09:45:00 Implementing an effective virus risk management plan Martin Wisher
10:25:00 Morning coffee and exhibition viewing time
11:05:00 Building a risk-based approach to the virus safety testing of live vaccine and gene therapy-based products Andrew Bailey
11:45:00 Virus safety risk assessment: a case study in virus safety risk reduction in a clinical manufacturing facility
12:25:00 Spotlight presentation
12:55:00 Lunch and exhibition viewing time
14:00:00 Assessing different virus preparations and their impact on viral clearance results Joseph Hughes
14:40:00 Alternative Virus Validation Filtration Strategy Using Bacteriophage as a Model Virus Rachel Specht
15:20:00 Afternoon tea and exhibition viewing time
15:45:00 Application of generic virus reduction data – can in-house data support viral safety for re-developed or scaled-up process steps or other products?
16:25:00 Virus removal by steps of the cold ethanol fractionation process: A review Herbert Dichtelmüller
17:05:00 End of Conference
3D Tissue Models
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