Pathogen Clean Asia Summit
Date: May 15~16, 2013
Venue: Renaissance Shanghai Putuo Hotel
- Featuring the Thought Leaders in the Pathogen Safety Community in Asia
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 over 100 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.
2013 Leading Discussions
• 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
Renowned Speaker Faculty includes
Dr. Arifa Khan, PhD, Senior Investigator, Office of Vaccines Research and Review, CBER, FDA
Prof. Dr. Dr. Rolf G. Werner, Professorship Industrial Biotechnology, University of Tuebingen, Germany
Albrecht Groner, Head, Pathogen Safety, CSL Behring
Dr. Rosemary Versteegen, Chief Executive Officer, International Serum Industry Association
Katsushi Murai, Engineer, Technical Development, Japanese Blood Products Organization
Mikihiro Yunoki, Manager, Pathogenic Risk Management, Japanese Blood Products Organization
Arun Prasath, Senior Manager, Operations, Singapore Blood Cord Bank
Peter Gagnon, Senior Research Technology Specialists, Singapore Bioprocessing Technology Institute
Thomas Yuan, Director, Development Center for Biotechnology
Prof. In-Seop Kim, Department of Biological Sciences, College of Life Science and Nanotechnology, Hannam University
Scott M. Wheelwright, VP, and COO, Innovent Biologics, China
Jason Li, Senior Director, Downstream Processing, Genor Biopharma
Zhiwei Pan, Director, Cell Culture, Process Development, Zhejiang Teruisi Pharmaceutical
Dr. John Zeng, Vice President, R&D and Clinical Manufacturing, Shanghai Zerun Biotech
Ji Yu, Deputy General Manager, Hisun Biopharmaceuticals
Dr. Ke Wu, President, Shanghai BravoBio
For more information about speaking, sponsorship and exhibition opportunities, please visit: www.pathogenclean.com Or Contact: Victor Zhang, Partner, Deliver Consulting