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The Asia Biopharma Continuous Manufacturing & Process Innovation Conference 2019

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The Asia Biopharma Continuous Manufacturing & Process Innovation Conference 2019

 
September 19-20, 2019 ∣ Holiday Inn Shanghai Jinxiu
 
Continuous manufacturing is considered as a new trend in future, it has the potential to increase the efficiency, flexibility, agility and robustness of manufacturing by reducing the number of steps and holds, utilizing smaller equipment and facilities, improving product quality and enabling real-time release. China has a big market in bio-manufacturing, many Chinese bio companies are catching their eyes on continuous bioprocessing. In this process, the single use technologies have been widely adopted when accomplish a completed continuous manufacturing.
 
Under this background, The Asia Biopharma Continuous Manufacturing & Process Innovation Conference 2019 invites experts from FDA, Universities, Biopharmaceuticals, Research Institutes, and Solution Providers in bioprocessing to share their latest endeavors in developing up- and down-stream continuous bioprocesses from lab to GMP, and in exploring strategies and technology enablers for continuous bioprocessing of novel products, process intensification and advanced process controls.
 
Key topics:
♦ Regulatory Updates and Quality Consideration in CM
♦ Asia Biologics Trend and Manufacturing Challenges
♦ Continuous Bioprocessing and Single Use Technologies in Up-and Down-Stream
♦ Integrated continuous manufacturing case study
♦ Cell Culture, Perfusion/Chromatography application
♦ Bio-Manufacturing 4.0, Automation and Digitalization
♦ CMC Requirements in CM
 
Agenda at a glance:
 
08:50 Welcoming Address and Opening Remarks by Chairman
Dr. Scott Liu, President and CEO, Henlius Biotech
09:00 The CMC Requirement in FDA Bioproduct Evaluation and Approval with Continuous Manufacturing
Dr. Liu Juhong, Previous Review Chief, CMC Biologics, FDA
09:30 Recent Trends and Technique Innovation of Biopharmaceutical Manufacturing in Japan
Prof. Lee Ineui, Project Professor, Kobe University, Previous CMC Technical Regulatory Affairs in Chugai pharmaceuticals
10:00 Topic to be confirmed
Dr. Scott Liu, President and CEO, Henlius Biotech
10:30 Coffee Break & Business Networking(15mins)
10:45 History and Developing Trends of Biopharma Manufacturing: Highly Specialized Platform
Dr. Shun LUO, CEO, Thousand Oaks Biopharmaceuticals Group
11:15 ISKIDTM – Integrated Process Platform and Equipment Design for Continuous Manufacturing
Dr. Min Zhu, Sr. Director of Protein Science, Boehringer Ingelheim
11:40 Effectively Integrating Automation into Single Use Bioprocessing
Mr. Kevin Seaver, GM, Bioprocess Automation and Digital, GE Healthcare
12:10 Panel Discuss (topic to be confirmed)
12:40 Lunch Buffett & Business Networking
14:00 Current Challenges of Biologics Manufacturing in China and New Manufacturing Trend
Dr. Xu Wei, VP of Manufacturing, Innovent Biologic
14:30 Applying New Biologics Manufacturing Technologies: Case Study from Amgen Singapore Site (TBC)
Dr. Yusdy Pan, Principal Scientist, Amgen Singapore (TBC)
15:00 Continuous Bioprocessing – The Alignment of Future Strategies to Industry 4.0
Mr. Peter Levison, Executive Director Business Development, Pall Corporation
15:30 Coffee Break & Business Networking(15mins)
15:45 Large Scale Intensified Cell Culture Processes – New Development Tools and Case studies
Gerben Zijlstra, Global Tech Expert, Sartorius Stedim Biotech GmbH
16:15 Avengers 5: The Quest for Continuous Infinity Stones: An Obligatory Study of Continuous Bioprocess Economics
Donald Palahnuk, Vice President, LSPD-TT (MST), TopAlliance Biosciences
16:40 Comparison of ddPCR and qPCR in Quantification of Advanced Therapy Products in Biological Samples—Sponsored by Bio-Rad
KOHARA Sakae, Research Director, Shin Nippon Biomedical Laboratories (SNBL Japan)
17:10 Continuous Biomanufacturing: New challenges and Perspectives
Prof. Dong Qiang Lin, Zhejiang University
17:30 Panel Discuss (topic to be confirmed)
Chairman: Miriam Monge, Head of mAb and Recombinant Protein Market Segment, Sartorius
18:00 End of Day One
DAY 2| September 20
09:00 Commercialized Continuous Manufacturing of Biopharmaceuticals: High Risk - High Return
Dr. Liu Xun, Vice President for Processing, Shanghai Hengrui Pharmaceutical
09:30 End to End Platform and Solutions for Continuous Manufacturing: Case Study and Updates from WuXiUP
Peter Shen, VP Process Development and Clinical Manufacturing, WuXi Biologics
10:00 Developing and Applying Integrated Continuous Bioprocessing Platform to Biologics Development and GMP Production in a Highly Flexible Modular Manufacturing Facility
Dr. Chris Huang, CTO, Transcenta Group
10:30 Coffee Break & Business Networking(20mins)
10:50 From “Batch Mode” to “Continuous” Bioprocessing: How the Virus Filter Fits in?
Dr. Julie Kozaili, Scientist, Asahi Kasei
11:20 High productivity harvest: new strategy for intensifying harvest and dispacing depth filtration in fed-batch cell culture
Huan Xiong, Field Application Scientist, Upstream, Repligen
11:40 Glycoengineering of CHO Cells for Continuous Production of Recombinant Therapeutics with Enhanced Efficacy
Dr. Song Zhiwei, Senior Principal Scientist, A*STAR, Singapore
12:10 Panel Discussion: COG Comparison for Single Use Technology: Batch VS Continuous?
12:40 Lunch Buffett & Business Networking
14:00 Facility of CBM (Continuous Bio MFG)
Michael Lee, CEO, PKU Bio Company
14:30 Large Scale Manufacturing and Quality by Design:  Batch vs Continuous (TBC)
David C. H. Jan, Ph. D, SVP Manufacturing, Teruisi Pharmaceutical Inc
15:00 Regulatory updates and Quality Consideration for Cell and Gene Products Manufacturing
To be confirmed
15:30 Coffee Break & Business Networking(20mins)
15:50 Bioprocessing 4.0 – Digital Technologies are Transforming Biologics Manufacturing
Thorsten. Bart Moors, Vice President for Biopharma, Siemens (Inviting)
16:20 Intelligent Bio-Manufacturing: The Perfect Combination of Efficiency and Compliance
Dr. Jennifer Jiang, Head of Life science, Schneider Electric
16:50 Topic Open for Sponsor
Contact: rickyli@chujietech.com
17:10 Case Study of Cell and Gene Therapy Medicine Manufacturing Process Design Strategy and Automation
Novartis (TBC)
17:30 Closing Remarks
17:45 END OF DAY TWO
DAY 3| September 21
Site Visiting
Location: Wuxi Biologics Factory based in Shanghai Zhangjiang
Time: 9:00 AM~12:00 AM | September 21
Limited Attendees: 20
Requirement: Only open to biopharmaceuticals
Please contact: rickyli@chujietech.com for site visiting.
 
How to register ACMC 2019?
Please click the link:
 
Contact us
 
Ricky Li
Tel: +86 17612157947
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