生物医药品在市场上，以重要的医药品等级持续成长，多数为利用哺乳动物的细胞培养而进行生产。生物医药品的总销售额达将近1,300亿美元，占整体医药品市场约13%。＂ 本学会提供业界领袖们，一个克服开发健康细胞株并成功上市相关各种课题的平台。

（第4届亚洲细胞株开发与工程年会）

本活动将聚焦在细胞工程上受到关注的动向，并检证生物制程技术的有效最佳实务，同时深入探讨抗体开发的最新技术。我们将提供予所有规模的企业，提升效率与生产性、保证生产品质的最佳工具与制程。

学会主要议题：

• 醣化作用与标的转殖的未公开新数据
• 运用组学技术以改善/导引/工程特定产品的结构品质
• 细胞培养液开发、优化、流速策略
• 殖株筛选及选定上的进展
• 来自细胞株的双特异性抗体治疗药物之开发

Biopharma Development & Production (BDP) Week为药厂、生技企业、CMO（医药品制造受托机关）、CRO（医药品开发业务委托机关）、研究机关、投资公司、相关企业的代表齐聚一堂之活动，将是参加者们建立人脉、讨论现在的业界趋势、建立合作关系、获得中国与周边亚洲各国投资机会等最新情报的宝贵机会。

（第4届亚洲细胞株开发与工程年会）

建议参加理由：

• 提供在细胞株开发的所有阶段上，效率与品质的最大化以及成本降低的最新技术。
• 透过细胞培养液优化与转染技术的最佳实务，促进早期阶段的细胞开发，并导入最新的殖株筛选及选定技术。
• 获得有效的生物制程管理与优化策略以达到有效、安全且高成本效益的规模扩大。
• 获得标的探勘的新筛选策略、ADC的课题、抗体治疗药物的双特异性工程与有效性的促进等抗体开发相关的最新动向。

丰富的学习与人脉建立的机会：

• 关注议题的互动式圆桌讨论：
• 与药厂及生技企业干部们的1对1面谈
• 在交流午餐会与会VIP贵宾与建立商业夥伴关系
• 社交鸡尾酒会
• 名片交换以及与生物医药品开发及生产同业的破冰机会

更有以下的专题讨论会，千万不要错过：

• 制程技术移转与高品质的cGMP制造
• 抗体开发－技术创新与标的选定
• 生物制程开发：与生物制剂接触之材料的品质与安全性相关考察
• 因应蛋白质治疗药物配方开发的QbD策略

08:00 报到登记与晨间咖啡

08:50 IBC Asia引言：名片交换等

09:00 议长开会致词：Abdullah Baaj, CEO, Boston Oncology, USA

生物制药业界展望专题演讲研讨会

9:05 全球生物医药品业界展望：2015年以后的机会与课题

• Macro-analysis of the current biopharma environment and market drivers，What are the constraints, opportunities and challenges?
• Innovation in the industry- who is taking the lead? Who are the silent players?
• How is Big Pharma and Biologics Majors reacting to the Biosimilars opportunity?
• Where are the Next Generation MaBs Biosimilars likely to come from?
• Is there money to be made from Biosimilars?
• Pros and cons of serving multiple growing markets

Moderator:

Yariv Hefez, Vice President Business Development, Portfolio Management, Strategy and Partnering, Biosimilars Unit, Merck Serono, Switzerland

Panelists:Abdullah Baaj, CEO, Boston Oncology, USA

Racho Jordanov, President & CEO, JHL Biotech, Taiwan

Richard O'Keeffe, Executive Director, International Quality -Japan-Asia-Pacific (JAPAC) Regional Quality Head, Amgen,Singapore

9:45 中国成长中的生物科技市场相关最新动向

• Perspectives on China's biotech policies, regulation and markets
• Can Chinese Biosmilar brands compete effectively against Indian and Korean Biosimilars globally?
• Information on the local regulatory and Government policies，
• Private vs publicly funded biopharma research and development，
• Growth strategies and key for success in a highly competitive market

Moderator:

Shou-Bai Chao, Senior Vice President, Bio Ventures, Global Operations, AstraZeneca, China

Panelists:

Joe Zhou, CEO, Walvax Group, China
Li Shi, CEO, Shanghai Zerun Biotechnology, China
Michelle Yu Xia, Chairman, President & CEO, Akeso Biopharma, China
Scott Liu, CEO, Henlius Pharmaceuticals, USA

10:25 中国发展中的生物医药品业界政策与法规

• Update on China's Biosimilars guidelines and biologic regulations
• Biomanufacturing standards。
• Testing, GMP Inspections and product quality

Senior Representative, China Food and Drug Administration (CFDA), China

10:50    人脉建立机会与休息时间。

弹性设施与新生物药品制造技术

11:30   议长开会致词：Pengfei Zhou, CEO, Wuhan YZY Biopharma Co Ltd, China

11:40   因应殖株选定及时程缩短的有效筛选策略

• Current challenges in streamlining selection and clonal isolation
• Review of latest technologies to overcome these challenges and suggestions to reduce timelines
• Combining image processing and document tracking system for effective clone- picking
• Clonal cell lines selection using Cell Metric™

Chaomei He, Principal Scientist, Momenta Pharmaceuticals, USA

针对生物生产品质提升的分析策略

12:10 链接细胞株产品品质特性的高通量（HTP）分析平台

• What are the major challenges met when using these HTP technologies, especially in mammalian cell line development?
• Novel HT technologies available for increased productivity and quality
• HTP analytical assays to facilitate product quality in the early stage of clone screening to hasten process development

Senior Representative, Lonza

12:40  提升细胞培养成果与产品品质的CHO细胞多组学分析与虚拟模型之集成

• Mammalian systems biotechnology framework
• Integrated bioinformatics platform for multi-omics profiling and analysis
• Genome-scale metabolic/regulatory modelling and in silico analysis of CHO cells
• Characterizing cell cultures and identifying metabolic and regulatory signatures for cell line development

Dong-Yup Lee, Assistant Professor, Department of Chemical and Biomolecular Engineering, NUS

13:10    午餐会与贵宾桌

• VIP Table 1: Peng Wang, President of R&D, Yabao Pharmaceutical Group, China
• VIP Table 2: Zou Ping, Vice Director, Shanghai CPGJ Pharma, China
• VIP Table 3: John Xu, CSO, Shanghai Benemae pharma & VP, Shanghai Mabicine, China

Exchange business cards and have an informal chat with the above guests during the networking lunch!

14:30 座谈会

Each leader will facilitate the discussion for 45 minutes. Leaders will then share key takeaways on the stage for 5 minutes each.

• 座谈会 1：因应提升速度、剂量、产品品质的新细胞株开发与生物制程方式——Cheng Zhang CSO, Gmax Biopharm, China
• 座谈会 2：因应有效且高成本效益的生物医药品生产的原材料及供应商管理策略——Chiali Liu, Manager, Microbial and Cell Culture Development, GSK, USA        
• 座谈会 3：重要的QbD概念于生物医药品的细胞培养与生物制程开发上的应用 ——Hung Fai Poon, Director, Cell Culture, Hisun Pharmaceuticals, China 

15:30 人脉建立机会与休息时间

因应成长优化的细胞培养液

16:10  既有组成培养液的个别优化

• Best practices in media formulation, optimization and preparation
• Implementing the most optimal conditions
• How can the host cell be made to effectively preadapt to suspension and serum-free media, and thus cutting short the overall developmental timeline?
• Optimizing medium for a fed batch culture or develop an optimized growth medium for large scale production
• Analytical tools and high-throughput protocols in increasing cell densities

Chuan He, Process Development, Senior Scientist, Beijing Mabworks Biotech, China

醣化作用的优化

16:50  因应品质提升的生物制程开发之高通量与高解析醣化作用分析

• How does the glycosylation profile impact quality of bioproducts
• How glycosylation variation can affect structure, effector function and product stability
• Importance of glycosylation analysis in bioprocess development
• Strategies and techniques to incorporate glycosylation analysis in bioprocessing for high quality products

Dr Peiqing Zhang, Assistant Professor, Department of Anatomy, Yong Loo Lin School of Medicine, NUS Singapore

17:30  议长总结&学会首日结束

18:00  社交鸡尾酒会

• VIP 1: Scott Liu, CEO, Henlius Pharmaceuticals, USA 
• VIP 2:  Feng Tian, Head and Director, Ambrx China
• VIP 3 : Wen-Chen Suen, Chief Scientific Officer, Biologics Division, HEC Pharm, China

Exchange business cards and visit the above guests!

9:00   议长开会致词

新细胞株开发平台与表现系统

9:05  细胞株开发平台：各种细胞株表现平台的分析

• Review of mammalian vs non-mammalian expression systems 
• Comparison of safety, cost and quality of various cell lines
• Future trends in moving away from CHO cell lines
• Novel Expression Systems- Case study of Amgen's targeted integration approach

Dayou Liu, Senior Scientist, Amgen,  USA

9:40  [座谈会]稳定表现系统与暂时表现系统的最大极限运用

• Review and discussion of stable vs transient cell lines- pros and cons
• Overcoming the regulatory hurdles involved
• Recent advances in transient transfection and cell culture methods
• Suspension cell culture lines vs in plated cell lines

Panelists:
Xiang Yang Zhu, CEO at Huaota Biopharm, China
Dayou Liu, Senior Scientist, Amgen,  USA
Cheng Zhang CSO, Gmax Biophar, China

10:20 人脉建立机会与休息时间

10:50  使用标的型基因工程的CHO细胞技术的进化

• Horizon's GS Null cells
• Industry need
• Engineering
• Critical Quality Attributes (CQAs) in cell production systems: what makes a "Good CHO"
• Using engineering to improve these CQAs
• Different engineering technologies
• Different targets
• Large scale engineering in one line
• Future plans to continue

Dr Jamie Freeman, Bioproduction Product Manager, Horizon Discovery, U.K

11:30  位置效应的克服”－因应细胞株开发的染色体热点之标的转殖

• Strategies for identification of chromosomal integration sites which provide high and stable gene expression
• Enhancing efficiency of targeted integration using cutting-edge technologies (Meganuclease, ZFN, TALEN and CRISP)
• Different vector designs for co-expression of light chain and heavy chain and impact on monoclonal antibody expression and quality   
• Yuan Sheng Yang, Senior Staff Research Scientist, Bioprocessing Technology Institute

有效的生物制程设计与规模扩大策略

12:10  提升品质与效率的生物制程设计策略

• Developing a QbD strategy in cell line and process development
• Considerations for the quality and safety of materials in contact with biologics
• Tips to accelerate biopharmaceutical development
• Define and align development activities for each stage
• Streamlining technlogy transfer processes
• Applying  single-use technologies

Zhiwei Pan, Senior Director, Cell Culture Process Development, Livzon mAbpharm, China

12:50 午餐会

• VIP Guests:
• VIP Table 1: Pengfei Zhou, CEO, Wuhan YZY Biopharma Co Ltd, China
• VIP Table 2: Andy Tsun, Senior Manager & Group Head, Novel Drug and Cell Line Development, Innovent Biologics, China
• VIP Table 3: Xiang Yang Zhu, CEO, Huaota Biopharm, China

Exchange business cards and have an informal chat with the above guests during the networking lunch!!

14:30  因应有效规模扩大的流速与生物反应器策略

• Which cell culture process to choose -Fed-batch vs continuous-perfusion culture review
• Case Study on Single-use disposable/ miniature bioreactors  for clone selection
• High-titre cell culture processes and scale up strategies

Hao Chen, Principal Scientist, Merck, USA

15:10   细胞培养制程规模扩大的成功确保

• Strategies to maximize productivity, enhance process reproducibility and facilitate scale-up
• Being aware of scale-up effects on process performance and product quality
• Questions and considerations when moving to production scale
• Tools and studies to help answer the questions
• Developing a strategy for efficient scale-up

Chiali Liu, Manager, Microbial and Cell Culture Development, GSK, USA       

15:50  人脉建立机会与休息时间

次世代生物制程趋势

16:20  [座谈会]次世代生物制程的动向

• Future of bioprocessing and trends
• Determining your key objectives: predictability, consistency, increased titers and higher quality
• Novel process controls, biosensor tools to increase efficiency of bioprocessing
• Smooth integration and linking of upstream and downstream processes
• Incorporating systems biology techniques
• Latest technologies and tools in bioprocessing to accelerate biopharmaceutical development

Moderator: 
Prof Rolf G Werner, Industrial Biotechnology Department, University of Tubingen, Germany

Panelists:
Chiali Liu, Manager, Microbial and Cell Culture Development, GSK, USA 
Hao Chen, Principal Scientist, Merck, USA
Zhiwei Pan, Senior Director, Cell Culture Process Development, Livzon mAbpharm, China

17:00    议长总结&学会第2天结束

生物制程的卓越营运之达成：实验设计法（DOE）于细胞培养上的应用

DoE is central to the Quality by Design (QbD) concept because it defines the design space of cell culture media and bioprocesses. Therefore, this workshop will focus on the application of DoE methods via the use of statistical software, bioprocess case studies, and hands-on software exercise and its application to multivariate analysis (MVA) during the optimization of culture media and bioprocesses. The case studies will focus on CHO cell culture with data to investigate the effects of factors such as medium components, pH, and temperature etc on cell culture productivity and protein critical quality attributes (CQA).

• Basic statistical concepts required for DoE
• How to design and analyze experiments for media and process optimization using mixture, factorial, fractional factorial, and response surface design
• How to interpret the output of experimental design software
• How to use the popular DoE software in designing and using MVA software to analyze experiments

Hung Fai Poon, R&D Director, Cell Culture Hisun Pharma (Hangzhou), China
Dr. Poon is currently the director of Cell Culture in Hisun Pharmaceuticals. He previously worked for SAFC, Roskamp Institute in USA. He completed hisPh.D. in Biological Chemistry at University of Kentucky, and MBA from University of South Florida. He has years of experience in the field of biological,analytical research, bioinformatics and proteomics. He has more than 10 yearsof cell culture experience with focus on biopharmaceutical products.He has published more than 30 peer-reviewed articles, and contributes to more than 5 book chapters. He is currently the associate Editor for Journal of Chemistry, Biochemistry and Molecular Biology, and Journal of Bioinformatics and Biometrics.

制程技术移转与CGMP制造的最佳实务

The workshop will cover the key aspects of bioprocess technology transfer for cGMP manufacturing. It will be a short practical course focusing on smooth scale-up, well-prepared technical transfer, and examine how new trends and developments in bioprocessing technology is best developed and translated to a GMP-robust manufacturing environment.

• Process development and optimization
• Project management and communication
• Raw material and supply chain management
• Confirmation batches and process fit analysis
• Document review and approval
• Deviation and investigation
• Case Studies

Hao Chen, Principal Scientist, Merck, USA
Workshop leader Bio:  Dr. Hao Chen is a Principal Scientist in BioProcess Development at MerckResearch Laboratories (Kenilworth, NJ, USA). He currently leads the Upstream & Recovery Process Development group for process development, scale-up,tech transfer, and initial process characterization. His group supports cell culture and fermentation projects from preclinical to commercial stage,including regulatory filings. Prior to Merck, he worked on upstream process/medium development and tech transfer for cell culture and fermentation in various companies including Becton Dickinson (BD) andAmylin Pharmaceuticals. Dr. Chen received his Ph.D. degree in Chemical Engineering from Purdue University. He also holds an MS in Biochemical Engineering and a BS in Fine Chemical Engineering, from Zhejiang University.

抗体开发的最新动向

9:00   Chairperson's Opening Remarks

Weidong Jian, CSO & VP, Henlius Biopharmaceuticals, USA

9:10   Strategies for Novel Antibodies and Biosimilars Development

• Selecting the right and appropriate clones for novel antibodies and biosimilars
• Developing a high expression, cost-effective cell line for antibodies 
• Case studies on Biosimilars development -Maintaining quality and quantity in biosimilars cell line  development

Pei Ye, Vice President, Beijing Mabworks Biotech, China

9:50   Novel Methods in Antibody Discovery and Characterization

• Screening for the Optimal Antibody Development Candidate Outline Profile (DCOP)
• Strategies in antibody characterization to ascertain the identification of antibody drug candidates
• ADCs, bispecifics analytic strategies  and characterization
• Case study: Biobetters and bispecific mAb initiatives

Weidong Jian, CSO & VP at Henlius Biopharmaceuticals, USA

10:30   Morning Networking and Refreshment Break

11:00   Strategies in Cell line engineering of Bi specific antibodies

• Challenges involving finding bispecific target pairs
• Optimising the antigen expression patterns
• Identifying the target criteria for different format types

Pengfei Zhou, CEO, Wuhan YZY Biopharma Co Ltd, China

11:40  Boosting Productivity and Efficiency of Biotherapeutics

• Achieve high titers via expression vector and secretory pathways
• Using efficient resins and sequential chromatography to attain high yields
• Attaining product efficacy and long serum half life for low doses
• High concentration liquid formulation techniques and convenient application processes

Prof Rolf G Werner, Industrial Biotechnology Department, University of Tubingen, Germany

12:20  Networking Lunch

13:30  Novel Strategies in Monoclonal Antibodies Targeting GPCRs

• Difficulties in generating functional antibodies against GPCRs and possible methods to overcome this
• An integrated Mab platform to generate functional Mabs against GPCRs
• Development of the Mabs towards biotherapeutics 

Cheng Zhang, CSO, Gmax Biopharm

14:10   Strategies in Fc Effector Function Analysis in Antibodies

• Assessing effector functions
• Ensuring similarity to original compound
• Strategies and integrated multi-assay approaches

Jingyi Xiang, Head of Bioanalytics,  Eureka pharma, USA

14:50   Afternoon Refreshments

15:20   Engineering of Antibody Drug Conjugates (ADCs) technologies 

• Established ADC technologies including monoclonal antibody formats, linkers and payloads
• Analyzing ADC performance- in vitro potency versus in vivo efficacy, and safety considerations
• ADC process development and scale up CMC strategies
• Strategies to enhance ADCC activity in ADCs

16:00   Chairman Closing Remarks and End of Post-Conference Special Focus Day