Agenda

Day 1

16 May 2017, Tuesday

08:00
Main Conference Registration and Morning Coffee
主会议注册和晨间咖啡

08:50
Welcome Address and Ice Breaker from IBC Asia

Opening Keynote Sessions
开场主旨演讲

Joint Plenary Sessions with Biosimilars Conference and Biomanufacturing Conference
全体会议

09:00
Chairperson’s Opening Remarks
主席致开场辞

09:10
Keynote Speech: Global Biopharma Outlook and its implication on China market
主旨演讲:全球生物制药前景及对中国市场的影响

09:30
Industry Leaders’ Panel Discussion: State of China Biopharma Industry – What can We Look Forward to?
行业领袖专题讨论:中国生物制药的现状——我们该有怎样的预期?

  • Overview of the current and emerging local trends
  • Regulatory Updates: Changes to regulatory requirements in China
  • Global harmonization in quality and regulatory requirements – are we on track?
  • Highlighting opportunities and challenges in Biomanufacturing, cell line development and Biosimilars markets in China  

Moderator:
Ming Wang, President and CEO, Phanes Biopharmaceuticals, U.S. and China

Panelists:
Wu Youling, CEO, Zhejiang Teruisi Pharmaceutical, China
Fu Daotian, General Manager, Livzon Mabpharm, China
Li Shi, CEO, Shanghai Zerun Biotechnology Co. Ltd, China
Wu Chengbin, CEO, EpimAb Biotherapeutics Inc., China

10:10
Global Biopharma Expansion, Investments and Risk
全球生物制药扩张、投资及风险

  • Perspectives on the evolving risks and opportunities in the biopharmaceutical industry
  • Key changes in the pipeline of biopharma products over the past year and what to expect in the long-run
  • Insights on growth strategies and how to manage risks associated with geography and product development

Billy Cho, Director of Healthcare, Asia Pacific, Citi Bank, Hong Kong

10:30
Morning Networking and Refreshment Break
自由交流及茶歇

Optimization of Media and Clone Selection
在细胞系研发早期更好使用媒体基础优化效价

11:00
Chairperson’s Introduction

James (Jianguo) Yang, President/CEO, Abpro-China, China and U.S.

11:05
[Case Studies] Strategies for Developing a Chemically Defined Medium for High Cell Density Perfusion Process
以化学为培养基的高细胞密度灌注过程开发策略

  • Perfusion trends
  • Methodology in medium development
  • Scale down models for perfusion process
  • Criteria in perfusion media development

David Han, Head of Upstream & System RD China, Merck

11:35
A New, High Efficiency Seeding Method for Rapid Establishment of Monoclonal Cell Lines

  • Overview of the latest regulatory presentations on the topic of monoclonality
  • Review of current seeding methods and probability of clonality determination
  • The impact of a new, intelligent seeding approach on workflow, probability of clonality and regulatory assurance data

George Hutchinson, Head of Asia Pacific Business, Solentim Ltd., U.K.

12:05
Networking Lunch and VIP Tables
自由交流午餐及VIP

VIP Table 1: Data Integrity and Compliance
VIP
台1:数据完整性和合规
Hosted by Zhihao (Peter) Qiu, Branch Chief, Division of Inspectional Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality, CDER, FDA

VIP Table 2: Technology Transfer from One Site to Another
VIP
台2:不同地方之间的技术转移
Hosted by: Grace Zheng, Director of DSPD, Wuxi Biologics

VIP Table 3: Filling the Evidence Gap: Strategies for Generating High-Quality Real World Evidence (RWE)
VIP
台3:填补证据空白:获得高质量实际循证的策略

VIP Table 4: Statistical Considerations in Comparability Studies & Clinical Trials
VIP台4:比较研究和临床试验中的数据考量

VIP Table 5: Data Package to Support Production Cell Line Change During Clinical Development
Hosted by JuHong Liu, Acting Review Chief, Division of Biotechnology Review and Research IIOffice of Biotechnology Products, Office of Pharmaceutical Quality, CDER, FDA, U.S.

VIP Table 6: mAb Therapeutics and Their Expression
Hosted by Cheng Zhang, Chief Scientific Technology Officer, Gmax BioPharm LLC, China

Exchange business cards and have an informal chat on the above topics. Stay tuned for table hosts updates! 

Innovative CHO Cell line Development Technologies and Approaches
创新CHO细胞系研发的技术和方法

13:00
[Case Studies] Accelerating Media Optimization with Platform Approach

  • Modular 3-phase approach for a successful media optimization for CHO cells
  • Media screening with pre-optimized panel of animal-origin free (AOF), chemically defined (CD) media and feeds
  • State-of-the-art media optimization, feed development and verification by STR culture with fully cGMP-compliant facilities

Eleni Mumtsidu, Director of Cell Culture Media, Sartorius Stedim Biotech, Asia

13:30
CHO Targeted Integration (TI) Cell Line Development and Cell Engineering for Rapid, High Level Production of mAbs with Controlled Glycosylation 
通过CHO定点整合细胞系研发和细胞工程来获得生产迅速,层级高的控制糖基化的单克隆抗体

  • A FLP/FRT recombinase mediated cassette exchange (RMCE)-based targeted integration platform for rapid cell line development and accurately control cell engineering
  • Precise control of GnTIII and ManII expression in CHO cells for producing mAbs with low fucose for enhanced ADCC
  • Production of mAbs with more homogeneous glycan structures
  • Developing biosimilar antibody producing cell lines with high similarity to innovator drugs

YuanSheng Yang, Staff Scientist, Bioprocessing Technology Institute, Singapore

14:00
Cell Line Development Workflows
细胞系研发的工作流程

  • Reduced cell line development timeliness
  • Importance of expression vector
  • Clone selection in high throughput bioreactor system

Scott J. Jacobia, Associate Director, R&D, Thermo Fisher Scientific, U.S.

14:30
Expression from Transient and Stable CHO Pool Platforms for Early Stage Therapeutics Development
CHO
细胞库平台从瞬态到稳态的表现来获取早期治疗方案的推进方案

  • CHO transfection automation
  • Stable CHO pool generation and scale-up
  • Product quality transient vs stable

Yves Durocher, Section leader of Mammalian Cell Expression, Human Health Therapeutics Portfolio, National Research Council Canada &Assistant Professor, Department of Biochemistry, University of Montreal, Canada

Revolution of Genome-editing Methods for Cell Line Engineering
基因组编辑工具在细胞系和宿主细胞工程上的革新应用

15:00
Engineering Cells to Facilitate Drug Discovery
细胞生物工程对药品研发的帮助

  • Screening for drug targets by genome-editing
  • Engineering therapeutics cells by genome-editing
  • Tissue engineering by genome-editing

Senyon Teddy Choe, Director/President, Mogam Institute for Biomedical Research, Korea & Professor, University of California, U.S.

15:30
Afternoon Networking & Refreshment Break

Assay Development and Screening

16:00
[Case Studies] Development of Functional Cell Lines for Bioassays

  • The role of bioassays in antibody discovery and development
  • The Report Gene Assay (RGA) has been widely used in bioassays
  • One case study using RGA cell lines to explore the therapeutic potential of a Fc-fusion protein
  • Another case study using RGA cell lines to screen functional antibody candidates

Lisa Shen, Head of R&D Department of Genetic Engineering, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd., China

R&D, Regulatory and Commercial Consideration for Cell Line
针对细胞系研发、政策监管、商业化的

16:30
Fast Road Map for Biologic RD
生物制剂研发的快速路径图

  • Biologic drug RD overview
  • RD bottlenecks from discovery to cell line and manufacturing development
  • Strategic partnership
  • Future RD landscape

James (Jianguo) Yang, President/CEO, Abpro-China, China and U.S.

17:00
[Case Studies] Regulatory Expectations and Case Studies for Product Cell Line Development
[
案例研究]细胞系产品研发的监管期待和案例研究

  • Balancing speed and productivity: product cell line development to suit early clinical studies and commercial production
  • Strategies to documenting high probability of monoclonality of production cell lines
  • Measures to ensure consistent product quality when changes are observed for a production cell bank

JuHong Liu, Acting Review Chief, Division of Biotechnology Review and Research II, Office of Biotechnology Products, Office of Pharmaceutical Quality, CDER, FDA, U.S.

17:30 
Comparability Strategy Development Supporting Cell Line Change at Commercial Stage
细胞系在商业化阶段发生更改的情况下所能提供支持的比较策略研发

  • Commercial cell line development strategy
  • Impact of cell line change on both CMC and regulatory
  • Comparability strategy development

Yun Bai, Senior Director, Process Sciences and Manufacturing, Ambrx Inc, U.S.

18:00
Chairperson’s Summary and End of Main Conference Day One
主席总结,当日议程结束

 

*Session outline may change to accommodate market-specific or company development.
会议大纲可能会根据市场具体情况和公司的发展状态做出适当调整

Day 2

17 May 2017, Wednesday

08:50
Chairperson’s Opening Remarks
主席致开场辞

WeiDong Jiang, CSO and Vice President, Henlix Biopharmaceuticals, U.S.

Process Development and Scale-up to assure High Yield and High quality
通过流程研发和增产来保证高产出和高质量

09:00
Cell Line Development: Taking Biological Therapeutics from DNA to Production
细胞系发展:生物治疗学 - 从DNA到生产

  • Cell Line Selection - Stability and Productivity
  • Robust and Scalable Processes
  • Future Perspectives

SongHooi Teh, Lead Scientist, Lonza, Singapore

09:30
Chemically-Defined Media Development & Optimization for Industrial Cell Culture
针对工业细胞系的化学培养基研发和优化

  • Challenges in industrial cell culture media development and optimization
  • Rational Culture Media Design™ -  A Method Integrating the Art and Science of Process Improvement
  • Case studies: Rational Culture Media Design™ approach in developing chemically-defined media for commercialization of biologics including therapeutic antibody and vaccine

Jessie H.-T. Ni, Ph.D. Chief Scientific Officer, Irvine Scientific

10:00
Systematic High Throughput Cell Culture for Process Development and Characterization
为流程研发和特性而进行系统性高产出的细胞培养

  • High throughput (HT) technologies review
  • Systematic HT cell culture in process development
  • Upstream process characterization with HT technologies

Yuan Wen, Director of Process Development, WuXi Biologics, China

10:30
Morning Networking and Refreshment Break
自由交流及茶歇

11:00
[Panel Discussion] Success-Oriented Late Stage Cell Line Development
专题讨论]以成功为导向的晚期细胞系研发

  • How to achieve high yield, scalable, robust and simple fed-batch process
  • Achieving stable cell line with cGMP compliance
  • Quality expectation driven by public demand and government regulations
  • Reducing downstream risk of adventitious agent contamination

Moderator:
Timothy Xia, Vice President, GenScript Co., Ltd.

Panelists:
Yun Bai, Senior Director, Process Sciences and Manufacturing, AmbrxInc, China
QiWei Wu, Vice President, Technical Operation, Process Development, Mabspace Biosciences Co. Ltd., China
John (XianFang) Zeng, Executive Vice President, Shanghai Zerun Biotechnology, China

11:30
Small Scale Screening and Scale Up Challenges
小规模筛选和扩大规模的挑战

  • Two stages of Scale-up
  • Stage I : From Screen to Process Development
  • Stage II : From Process Development to Manufacturing
  • Case Study: From 3L to 2K L

Frank Li, Associate Manager of Upstream Process Development, APAC End to End\ Biodevelopment Delivery, Merck, China

12:00
Networking Lunch and VIP Tables
自由交流午餐及VIP

VIP Table 1: Building Bioanalytical Capabilities
VIP
台1:完善生物分析能力
Hosted by James Jia-Ming Yang, Associate Director, ADQC, Livzon MabPharm Inc., China 

VIP Table 2: Accelerating Biologics Development from DNA to First-In-Human (FIH)
VIP
台2:实现生物制剂研发从DNA到首次应用于人体的跨越式发展
Hosted by Zhou Weichang Zhou, Chief Technology Officer and Senior Vice President, Biologics Development and Manufacturing, Wuxi Biologics

VIP Table 3: Strengthening Market Access Environments in Asia & China
VIP
台3:优化亚洲及中国国家的市场准入环境

VIP Table 4: Challenges in Developing a Biosimilar Control Strategy
VIP
台4:制定生物仿制药控制策略中的挑战

VIP Table 5: Regulatory Requirement and Updates for Cell Line Development in China
VIP台5:细胞株建设在中国的法规更新

Hosted by MinMin Qin , Director/CSO, Technology Center for Antibody Therapeutics, National Translational Medicine Center for Molecular Medicine (Xian) & Distinguished Professor, Fourth Military Medical University, China

VIP Table 6: From Discovery to CHO cells
VIP台6:从药物发现到CHO细胞
Hosted by Andy Tsun, Director, Director of Functional Biology, Drug Discovery, Innovent Biologics Inc, China

Exchange business cards and have an informal chat on the above topics. Stay tuned for table hosts updates! 

13:00
[Case Studies] Discover Ways to Shorten the Cell Line Development Process and Empower Immuno-Oncology Research

  • Accelerate the process with OptoFluidic Manipulation by isolating thousands of single cells in individual nanofluidic chambers with the BeaconTM platform
  • Characterization of CHO cells within 5 days based on growth rate, titer and Qp in a manner that is predictive of performance in bioreactors
  • Easy selection and export of top-producing clones with better than 99% clonality and a complete visual record

Keith Breinlinger, VP of Engineering, Berkeley Lights, Inc, U.S.

Optimizing Technologies for Antibody Therapy

13:30
Host Engineering for Improved Product Properties and Quality Attributes
改进产品属性和质量属性的主机工程

  • Novel technologies for host engineering
  • Glycoengineering for enhanced ADCC
  • Optimizing product quality via cellular pathway modulations

MinMin Qin, Director/CSO, Technology Center for Antibody Therapeutics, National Translational Medicine Center for Molecular Medicine (Xian) & Distinguished Professor, Fourth Military Medical University, China

14:00
Developing Immune-oncology Antibodies for Therapeutics with Different Methodologies
研发肿瘤免疫抗体用于使用不同手段完成的疗法

  • Generating antibody clones from different methods
  • Testing for in vitro functions in whole cell assays
  • Testing for in vivo functions in several different animal models

WeiDong Jiang, CSO and Vice President, Henlix Biopharmaceuticals, U.S.

14:30
Optimizing Technologies for Bispecific Antibodies (bsAb) and Its Application
为双特异性抗体bsAb及其应用而进行技术优化

  • Control of quality (glycoforms) and potency of the clones in early cell line development
  • Improvement done for current technology
  • Combat low productivity with more efficient product systems
  • Impact of cell line development process on antibody expression

Jim Qiu, Executive Vice President, Wuhan YZY Biopharma, China

15:00
Efficiency Improvement of Therapeutic Antibodies
治疗性抗体的效率改善

  • Need to decrease therapeutic cost in oncology
  • Need to increase efficiency of therapy in oncology
  • Empowerment of therapeutic antibodies
  • Defucosylation technologies in cell line engineering

Rolf G. Werner, Professor, University Tuebingen, Germany

15:30
Afternoon Networking

Combined Closing Plenary Sessions

16:10
[Panel Discussion] Where Are We Heading from Here and How Should We Get There?
未来的发展方向是什么?我们如何达到目标?

  • Top 3 emerging trends with greatest growth potential
  • People and technology: how’re these forces working together
  • Taking local innovations and initiatives globally
  • The way forward: capitalizing on new technologies, collaboration and government initiatives

Moderator:
Joe Zhou, CEO, Genor Biopharma, China

Panellists:
Qian Xue Ming, CEO,Mabspace Biosciences, China
Zhu Xiang Yang, CEO, Huabo Biopharm (Shanghai) Co. Ltd, China

17.00
Chairperson’s Summary and End of Main Conference
主席总结,议程结束

 

*Session outline may change to accommodate market-specific or company development.

Pre Conference Workshop

Workshop A: 15 May 2017, 09:00 - 12:30

Designing CHO Cells and Plasmid Vectors for Efficient Manufacturing of Monoclonal Antibodies
设计CHO细胞和质粒载体以获得单克隆抗体的高效生产

Cell line development is one of the first and most important steps during both antibody development and manufacturing. It is a tedious and time-consuming process which could determine the timeline of a product reaching market, the volumetric yield and upstream cost of goods, and the efficacy and safety of the manufactured drug substance. This interactive workshop is aimed at all professionals interested to learn and discuss about novel technologies for cell line development to improve efficiency of antibody development and manufacturing.

Key learning outcome:  

  • Advantages and disadvantages of commercially available CHO cell expression systems for antibody development and manufacturing
  • Developing plasmid vectors for high antibody production levels using commonly used CHO cell lines, eg. CHO K1, CHO S, CHO DG44 and CHO GS-/-
  • A case study comparing novel targeted integration-based cell line development with traditional random integration-based cell line development
  • A method for precision engineering of the glycosylation pathway in CHO cells to produce monoclonal antibodies with (1) homogeneous and desirable glycan structures for enhanced efficacy and manufacturing, and (2) glycan structures highly similar to innovator drugs for efficient biosimilar development  

Profile

YuanSheng Yang
Staff Scientist
Bioprocessing Technology Institute, Singapore

Dr. Yuansheng Yang received his doctorate degree from Vanderbilt University’s Department of Chemical Engineering in 2005. Upon graduation, he joined the Animal Cell Technology group, Bioprocessing Technology Institute (BTI) in Singapore as a research scientist. He had been an adjunct assistant professor of Nanyang Technological University from 2012 to 2015. He currently leads a group working on vector design, cell line development, cell engineering, and bioprocess optimization to enhance the yield and quality of biopharmaceutical drugs produced using CHO cells. He has published over 40 papers and filed several patents related to developing cell lines for high level expression of monoclonal antibodies and other recombinant proteins.

 

Workshop B: 15 May 2017, 13:30 - 15:00

Continued Bioprocess for Monoclonal Antibody Production

Continued bioprocess is the major trend in biopharmaceutical production, including continued cell culture process and continued downstream process. Application of continued cell culture process can be found in both international and domestic commercial production, using traditional or innovation cell separation technologies. Major challenges in continued cell culture process include clogging of the cell separation apparatus, more media usage, etc., while advantages are smaller bioreactors and clean rooms, higher productivity, higher efficiency, higher flexibility and longer batch time. Overall cost and control advantage of continued process will need to be evaluated case by case.

Key learning outcome:  

  • Impact of culture condition on the product quality
  • Advantages and limitations of Quality by design (QbD) modernized approach to pharmaceutical development
  • Optimizing process characterization through risk assessment and well-defined control strategy

 

Profile:

Jason Li
Vice President, Manufacturing
Genor Biopharma, China

Jason Li has been with Genor Biopharma for 9 years. He has led the efforts of process development, preclinical studies, pilot plant, clinical manufacturing, technology transfer and commercial manufacturing. He had worked in process development of Amgen Thousand Oaks. He majored in Chemical and Biochemical Engineering in Tianjin University as well as University of Maryland Baltimore County.