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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
