- 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
- 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
- Update on China's Biosimilars guidelines and biologic regulations
- Biomanufacturing standards。
- Testing, GMP Inspections and product quality
- 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™
- 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
- 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
- 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
- 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——
- 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
- 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
- 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
- VIP 1: , , 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
- 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
- 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
Xiang Yang Zhu, at Huaota Biopharm, China
Cheng Zhang CSO, Gmax Biophar, China
- 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
- 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
- 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
- VIP Guests:
- VIP Table 1:
- VIP Table 2: Andy Tsun, Senior Manager & Group Head, Novel Drug and Cell Line Development, Innovent Biologics, China
- VIP Table 3: Xiang Yang Zhu, , Huaota Biopharm, China
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- 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
- 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
- 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
会前专题研讨会A：2015年5月19日 - 上午9点 - 中午12点半 |
- 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
会前专题研讨会B：2015年5月19日 - 下午1点半 - 下午5点半 |
- 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
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.
会后专题研讨会C ―特别焦点日：2015年5月22日 |
- 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
- 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
- Challenges involving finding bispecific target pairs
- Optimising the antigen expression patterns
- Identifying the target criteria for different format types
- 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
- 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
- Assessing effector functions
- Ensuring similarity to original compound
- Strategies and integrated multi-assay approaches
- 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
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