生物醫(yī)藥品在市場(chǎng)上，以重要的醫(yī)藥品等級(jí)持續(xù)成長(zhǎng)，多數(shù)為利用哺乳動(dòng)物的細(xì)胞培養(yǎng)而進(jìn)行生產(chǎn)。生物醫(yī)藥品的總銷售額達(dá)將近1,300億美元，占整體醫(yī)藥品市場(chǎng)約13%。＂?本學(xué)會(huì)提供業(yè)界領(lǐng)袖們，一個(gè)克服開發(fā)健康細(xì)胞株并成功上市相關(guān)各種課題的平臺(tái)。

（第4屆亞洲細(xì)胞株開發(fā)與工程年會(huì)）

本活動(dòng)將聚焦在細(xì)胞工程上受到關(guān)注的動(dòng)向，并檢證生物制程技術(shù)的有效最佳實(shí)務(wù)，同時(shí)深入探討抗體開發(fā)的最新技術(shù)。我們將提供予所有規(guī)模的企業(yè)，提升效率與生產(chǎn)性、保證生產(chǎn)品質(zhì)的最佳工具與制程。

學(xué)會(huì)主要議題：

• 醣化作用與標(biāo)的轉(zhuǎn)殖的未公開新數(shù)據(jù)
• 運(yùn)用組學(xué)技術(shù)以改善/導(dǎo)引/工程特定產(chǎn)品的結(jié)構(gòu)品質(zhì)
• 細(xì)胞培養(yǎng)液開發(fā)、優(yōu)化、流速策略
• 殖株篩選及選定上的進(jìn)展
• 來自細(xì)胞株的雙特異性抗體治療藥物之開發(fā)

Biopharma Development & Production (BDP) Week為藥廠、生技企業(yè)、CMO（醫(yī)藥品制造受托機(jī)關(guān)）、CRO（醫(yī)藥品開發(fā)業(yè)務(wù)委托機(jī)關(guān)）、研究機(jī)關(guān)、投資公司、相關(guān)企業(yè)的代表齊聚一堂之活動(dòng)，將是參加者們建立人脈、討論現(xiàn)在的業(yè)界趨勢(shì)、建立合作關(guān)系、獲得中國與周邊亞洲各國投資機(jī)會(huì)等最新情報(bào)的寶貴機(jī)會(huì)。

（第4屆亞洲細(xì)胞株開發(fā)與工程年會(huì)）

建議參加理由：

• 提供在細(xì)胞株開發(fā)的所有階段上，效率與品質(zhì)的最大化以及成本降低的最新技術(shù)。
• 透過細(xì)胞培養(yǎng)液優(yōu)化與轉(zhuǎn)染技術(shù)的最佳實(shí)務(wù)，促進(jìn)早期階段的細(xì)胞開發(fā)，并導(dǎo)入最新的殖株篩選及選定技術(shù)。
• 獲得有效的生物制程管理與優(yōu)化策略以達(dá)到有效、安全且高成本效益的規(guī)模擴(kuò)大。
• 獲得標(biāo)的探勘的新篩選策略、ADC的課題、抗體治療藥物的雙特異性工程與有效性的促進(jìn)等抗體開發(fā)相關(guān)的最新動(dòng)向。

豐富的學(xué)習(xí)與人脈建立的機(jī)會(huì)：

• 關(guān)注議題的互動(dòng)式圓桌討論：
• 與藥廠及生技企業(yè)干部們的1對(duì)1面談
• 在交流午餐會(huì)與會(huì)VIP貴賓與建立商業(yè)夥伴關(guān)系
• 社交雞尾酒會(huì)
• 名片交換以及與生物醫(yī)藥品開發(fā)及生產(chǎn)同業(yè)的破冰機(jī)會(huì)

更有以下的專題討論會(huì)，千萬不要錯(cuò)過：

• 制程技術(shù)移轉(zhuǎn)與高品質(zhì)的cGMP制造
• 抗體開發(fā)－技術(shù)創(chuàng)新與標(biāo)的選定
• 生物制程開發(fā)：與生物制劑接觸之材料的品質(zhì)與安全性相關(guān)考察
• 因應(yīng)蛋白質(zhì)治療藥物配方開發(fā)的QbD策略

08:00 報(bào)到登記與晨間咖啡

08:50 IBC Asia引言：名片交換等

09:00 議長(zhǎng)開會(huì)致詞：Abdullah Baaj, CEO, Boston Oncology, USA

生物制藥業(yè)界展望專題演講研討會(huì)

9:05 全球生物醫(yī)藥品業(yè)界展望：2015年以后的機(jī)會(huì)與課題

• 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 中國成長(zhǎng)中的生物科技市場(chǎng)相關(guān)最新動(dòng)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 中國發(fā)展中的生物醫(yī)藥品業(yè)界政策與法規(guī)

• 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 ?? 人脈建立機(jī)會(huì)與休息時(shí)間。

彈性設(shè)施與新生物藥品制造技術(shù)

11:30 ? 議長(zhǎng)開會(huì)致詞：Pengfei Zhou, CEO, Wuhan YZY Biopharma Co Ltd, China

11:40 ? 因應(yīng)殖株選定及時(shí)程縮短的有效篩選策略

• 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

針對(duì)生物生產(chǎn)品質(zhì)提升的分析策略

12:10 鏈接細(xì)胞株產(chǎn)品品質(zhì)特性的高通量（HTP）分析平臺(tái)

• 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? 提升細(xì)胞培養(yǎng)成果與產(chǎn)品品質(zhì)的CHO細(xì)胞多組學(xué)分析與虛擬模型之集成

• 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 ?? 午餐會(huì)與貴賓桌

• 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 座談會(huì)

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

• 座談會(huì) 1：因應(yīng)提升速度、劑量、產(chǎn)品品質(zhì)的新細(xì)胞株開發(fā)與生物制程方式——Cheng Zhang CSO, Gmax Biopharm, China
• 座談會(huì) 2：因應(yīng)有效且高成本效益的生物醫(yī)藥品生產(chǎn)的原材料及供應(yīng)商管理策略——Chiali Liu, Manager, Microbial and Cell Culture Development, GSK, USA ? ? ? ?
• 座談會(huì) 3：重要的QbD概念于生物醫(yī)藥品的細(xì)胞培養(yǎng)與生物制程開發(fā)上的應(yīng)用 ——Hung Fai Poon, Director, Cell Culture, Hisun Pharmaceuticals, China?

15:30 人脈建立機(jī)會(huì)與休息時(shí)間

因應(yīng)成長(zhǎng)優(yōu)化的細(xì)胞培養(yǎng)液

16:10 ?既有組成培養(yǎng)液的個(gè)別優(yōu)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

醣化作用的優(yōu)化

16:50? 因應(yīng)品質(zhì)提升的生物制程開發(fā)之高通量與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? 議長(zhǎng)總結(jié)&學(xué)會(huì)首日結(jié)束

18:00? 社交雞尾酒會(huì)

• 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 ? 議長(zhǎng)開會(huì)致詞

新細(xì)胞株開發(fā)平臺(tái)與表現(xiàn)系統(tǒng)

9:05? 細(xì)胞株開發(fā)平臺(tái)：各種細(xì)胞株表現(xiàn)平臺(tái)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? [座談會(huì)]穩(wěn)定表現(xiàn)系統(tǒng)與暫時(shí)表現(xiàn)系統(tǒng)的最大極限運(yùn)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 人脈建立機(jī)會(huì)與休息時(shí)間

10:50? 使用標(biāo)的型基因工程的CHO細(xì)胞技術(shù)的進(jìn)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? 位置效應(yīng)的克服”－因應(yīng)細(xì)胞株開發(fā)的染色體熱點(diǎn)之標(biāo)的轉(zhuǎn)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

有效的生物制程設(shè)計(jì)與規(guī)模擴(kuò)大策略

12:10? 提升品質(zhì)與效率的生物制程設(shè)計(jì)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 午餐會(huì)

• 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 ?因應(yīng)有效規(guī)模擴(kuò)大的流速與生物反應(yīng)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 ? 細(xì)胞培養(yǎng)制程規(guī)模擴(kuò)大的成功確保

• 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? 人脈建立機(jī)會(huì)與休息時(shí)間

次世代生物制程趨勢(shì)

16:20 ?[座談會(huì)]次世代生物制程的動(dòng)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 ?? 議長(zhǎng)總結(jié)&學(xué)會(huì)第2天結(jié)束

?

生物制程的卓越營運(yùn)之達(dá)成：實(shí)驗(yàn)設(shè)計(jì)法（DOE）于細(xì)胞培養(yǎng)上的應(yīng)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.

制程技術(shù)移轉(zhuǎn)與CGMP制造的最佳實(shí)務(wù)

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.

抗體開發(fā)的最新動(dòng)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

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