The Asia Biopharma Continuous Manufacturing & Process Innovation Conference 2019

 

September 19-20, 2019 ∣ Holiday Inn Shanghai Jinxiu

Weblink: https://www.bagevent.com/event/5520024?bag_track=bagevent

 

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:

 

DAY 1| September 19

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:

https://www.bagevent.com/event/5520024?bag_track=bagevent

 

Contact us

 

Ricky Li

Tel: +86 17612157947

Email: rickyli@chujietech.com