Day 1

16 May 2017, Tuesday

Main Conference Registration and Morning Coffee

Welcome Address and Ice Breaker from IBC Asia

Opening Keynote Sessions

Joint Plenary Sessions with Biosimilars Conference and Biomanufacturing Conference

Chairperson’s Opening Remarks

Keynote Speech: Global Biopharma Outlook and its implication on China market

Industry Leaders’ Panel Discussion: State of China Biopharma Industry – What can We Look Forward to?

  • 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  

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

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

Global Biopharma Expansion, Investments and Risk

  • 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

Morning Networking and Refreshment Break

Optimization of Media and Clone Selection

Chairperson’s Introduction

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

[Case Studies] Strategies for Developing a Chemically Defined Medium for High Cell Density Perfusion Process

  • 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

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.

Networking Lunch and VIP Tables

VIP Table 1: Data Integrity and Compliance
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
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 Table 4: Statistical Considerations in Comparability Studies & Clinical Trials

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

[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

CHO Targeted Integration (TI) Cell Line Development and Cell Engineering for Rapid, High Level Production of mAbs with Controlled Glycosylation 

  • 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

Cell Line Development Workflows

  • 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.

Expression from Transient and Stable CHO Pool Platforms for Early Stage Therapeutics Development

  • 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

Engineering Cells to Facilitate Drug Discovery

  • 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.

Afternoon Networking & Refreshment Break

Assay Development and Screening

[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

Fast Road Map for Biologic RD

  • 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.

[Case Studies] Regulatory Expectations and Case Studies for Product Cell Line Development

  • 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.

Comparability Strategy Development Supporting Cell Line Change at Commercial Stage

  • 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.

Chairperson’s Summary and End of Main Conference Day One


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

Day 2

17 May 2017, Wednesday

Chairperson’s Opening Remarks

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

Process Development and Scale-up to assure High Yield and High quality

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

Chemically-Defined Media Development & Optimization for Industrial Cell Culture

  • 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

Systematic High Throughput Cell Culture for Process Development and Characterization

  • 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

Morning Networking and Refreshment Break

[Panel Discussion] Success-Oriented Late Stage Cell Line Development

  • 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

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

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

Small Scale Screening and Scale Up Challenges

  • 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

Networking Lunch and VIP Tables

VIP Table 1: Building Bioanalytical Capabilities
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)
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 Table 4: Challenges in Developing a Biosimilar Control Strategy

VIP Table 5: Regulatory Requirement and Updates for Cell Line Development in China

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
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! 

[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

Host Engineering for Improved Product Properties and Quality Attributes

  • 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

Developing Immune-oncology Antibodies for Therapeutics with Different Methodologies

  • 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.

Optimizing Technologies for Bispecific Antibodies (bsAb) and Its Application

  • 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

Efficiency Improvement of Therapeutic Antibodies

  • 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

Afternoon Networking

Combined Closing Plenary Sessions

[Panel Discussion] Where Are We Heading from Here and How Should We Get There?

  • 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

Joe Zhou, CEO, Genor Biopharma, China

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

Chairperson’s Summary and End of Main Conference


*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

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  


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



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.