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The “Pathogen Clean Asia Summit 2013” is the ONLY conference in Asia formulated and constructed to facilitate the recognition and awareness of pathogen and contaminant safety during whole bio-manufacturing process to meet with the evolving regulatory and patients’ needs for more qualified and safer bio-therapeutics. It will bring over100 professionals from process development, quality and regulatory compliance, bio-safety officer, microbiologist etc to discuss extensively on the TRIPOD underpinned the industry: sourcing and managing the qualified, consistent raw materials, implementing the effective and robust viral clearance studies, and robust in-process monitoring and testing.
• Latest regulatory pathogen safety requirement and compliance need from the US FDA Agency• Bioprocess strategies to ensure the quality and safety of protein therapeutics, mAbs, vaccines, plasma-derived products• Opportunities, risks and regulatory requirement for the application of animal-derived products
• Identify, assess and qualify raw materials and manage the changes
• Evaluate, characterize the cell substrate, viral seeds and medium optimization
• Risk analysis and barrier technologies for virus contamination in manufacturing process
• Latest methodologies, theories and innovation on equipment, technologies to purify biologics
• Advance on viral clearance studies and re-assessment the unit of operation for viral safety
• Latest virus screening and detection techniques and strategies for Mycoplasma, Hepatitis E contamination
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