產(chǎn)品列表PRODUCTS LIST
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
在線客服