2017生物制药上游技术亚太区巡讲强势来袭

回首2016，美国FDA共批准了7个抗体药物上市，但也有高度期望的重磅药物因各种原因相继折戟。与此同时，国内共有88个生物制品获批进入临床试验，尤其抗体药物的竞争日益增强。谁将成为最后的赢家，不仅取决于速度，还将受制于技术路线，生产工艺和相关环节的风险管控。

德国默克公司作为一家有着340多年历史的医药化工公司，自2007年以来先后收购了雪兰诺公司、Millipore公司、Sigma公司，具备了从细胞株构建、大规模培养、下游纯化和制剂技术的整体解决方案。尤其是旗下品牌SAFC，在过去40多年的发展中，为多款最畅销生物药品提供了关键的细胞培养产品和技术。为了协助企业规避风险，提升生产效率，我们特邀业内专家就生物制药上游工艺相关议题进行交流与讨论。

鉴于您在生物制药行业的丰富经验，我们诚挚邀请您于6月2日莅临上海浦东嘉里大酒店会场指导与交流！

会议日程

演讲嘉宾

Weichang Zhou

CTO of WuxiAppTec

Perfusion Cell Cultures for Biologics Manufacturing

Biography

Weichang Zhou, Ph.D.

Chief Technology Officer, WuXi Biologics, Senior Vice President

Over 25 years of broad industrial experience and demonstrated accomplishments in biologics manufacturing process development; Senior Director of Commercial Cell Culture Development at Genzyme, Senior Director of Process Sciences and Engineering at PDL BioPharma; selected as a fellow of the American Chemical Society in 2013; Ph.D. from University of Hannover, Germany.

Dr. H. Fai Poon

CSO of Hisun Pharma – Biopharm

Development of a Scale Up Cell Culture Model Using Metabolomics and Multivariate Analysis

Content

Since there are geometric differences between scales, bioreactors at manufacturing scale often vary from bench scale performance. Such differences are typically manifested in different cell growth, protein productivity, and/or protein quality.

Here, we describe a case study in which a scale up cell culture process model is developed to mimic historical bench scale performance using metabolomics and multivariate analysis.

We identify gaps between scales, and process adjustments were then implemented at manufacturing scale, This resulted in an successful scaled up cell culture process.

Biography

Dr. Poon is currently the CSO of Hisun Pharma – Biopharm. He previously worked for SAFC, Roskamp Institute in USA. He completed his Ph.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 years of cell culture experience with focus on biopharmaceutical products.

He 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.

Dr. Zhou Xinhua

The CEO of Genor Biopharma Co. Ltd

Panel Discussion

Biography

Founder and first Chair of China Protein Drug Quality Alliance (CPDQA), the Chair of Biological Drug Product and Process Committee of China ISPE. He has over 20-years experience of process development, multiple project management capacity in cGMP and non-GMP reproducible purification/production of protein/antibody therapeutics from FIH to CPD with depth knowledge of CHO clone selection, cell culture optimization, viral clearance, real time analytical assays, formulation and product specification for drug substances and drug products.

Aletta Schnitzler

Head of Collaborations, Cell Therapy Bioprocessing, Merck

Solutions for Robust Cell Therapy Production

Content

The long-term view of regenerative medicine therapies predicts an increased need for expansion solutions that ease scalability, utilize animal origin-free materials and are compatible with limited downstream processing steps. As more cell therapeutics progress through clinical testing, current in vitro culture methods are proving cumbersome to scale and lack robustness. Moreover, high quality animal origin-free reagents and downstream processing devices support the future implementation of production solutions that will be required following clinical success. Here, we describe the implementation of single-use bioreactors and high quality media for expansion of cell therapies. We include examples from allogeneic mesenchymal stem cells, autologous T cells and induced pluripotent stem cells.

The presentation will include case studies that demonstrate process improvements when using qualified media, serum alternatives, bioreactors and downstream purification technologies. Additionally, we will highlight the inclusion of process control strategies that further increase the efficiency of cell therapy production.

Start-to-finish solutions for expansion and harvest are key enabling technologies for success in commercializing cell therapies.

Biography

Aletta C. Schnitzler is the Head of Collaborations, Cell Therapy Bioprocessing Aletta has been with MilliporeSigma for a combined 9 years in Life Science business fields. She currently manages technology, process development and collaboration projects, providing expertise in cell therapy manufacturing, media formulation and single-use systems. Previous roles at MilliporeSigma include scientist in R&D and Field Marketing supporting small-scale chromatography devices, cell culture media products for monoclonal antibody production, and more recently for cell therapy applications. Aletta received her Ph.D. in 2007 from Boston University School of Medicine in the fields of immunology and neuroscience, focusing on trophic factors that influence immune cell activation, as well as neural differentiation and maintenance of phenotype.

Albert Cheong

Head of MSAT Upstream Asia

Bioprocessing Raw Materials: Risk Mitigation Strategies

Content

Variability is inherently introduced by bioprocessing raw materials. A detailed initiative to fully characterize raw materials using orthogonal techniques can provide assurance that the raw materials are as fit for purpose as possible. This approach also acts as a thorough risk mitigation step. Our raw material characterization program is an initiative taken as a direct result of biopharmaceutical customers'' feedback. The initiative focuses on developing unique tests to ensure functionality of the raw material that ultimately influences supply chain and procurement decisions.

Biography

Mr Albert Cheong comes with 13 years of life sciences experience, working in academic research laboratories as well as in the biopharmaceutical industry. He initially started as a Research Associate supporting academic research laboratories working on cancer cell migration and prostate cancer metastasis, to elucidating the role of maternal determinants present in the zebrafish oocyte on the dorsal/ventral axis of the zebrafish. 

Prior to joining SAFC, Sigma-Aldrich Pte Ltd (a subsidiary of Merck KGaA), he was a Senior Scientist at Lonza Biologics Tuas Singapore Pte Ltd,leading a small team on cell line development, process development (STRs, ALRs, waves) and pre-clinical material supply projects for APAC customers. Prior to Lonza, he was with S*BIO Pte Ltd developing cell-based assays and assessing in-house synthesised small molecule inhibitors (JAK2i, HDACi, mTORi) as drug combination treatments using a panel of cancer cell lines. He was directly involved with the HDACi molecule, pracinostat, before it was sold to MEI Pharma and currently entering PhIII trials. His personal interests are hairstyling and is fascinated in the molecular aspects of aging.

Edmund Ang

Principal Scientist for BioReliance, Merck

Virus Risk Mitigation - Regulatory Compliance and Reducing Risks of Viral Contamination in Biomanufacturing

Content

Viral risk mitigation of biopharmaceuticals and biologics is accomplished by a multi-tiered approach involving safety testing approaches throughout the development and manufacturing process. Cell bank characterization, to exclude adventitious agents, is an essential part of the strategy for assurance of safety of biopharmaceuticals. The safety program starts with raw material control, and involves in-process and bulk lot release tests and evaluation of the manufacturing process to inactivate or remove viruses. 

Recent regulatory guidance has focused on quality by design approaches to mitigate viral risk in raw materials and overall manufacturing processes. With this approach industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed approach to risk mitigation. The overarching strategy of risk mitigation includes evaluation of raw materials, environmental controls, upstream and downstream processing, testing and regulatory considerations . This presentation will discuss historical events, pathogen risk and will report on rapid testing methods for the detection of known and novel agents and will report industry trends from working with global biopharmaceutical partners.

Biography

Dr Edmund Ang is the Principal Scientist for BioReliance services providing scientific and technical support and thought leadership on biologics safety testing to biopharma in the Asia Pacific region. He has extensive life science research and development experiences from both academic and industrial settings. He obtained his PhD in Cell Biology from the University of Edinburgh, Scotland, UK, followed by postdoctoral research on cell signalling at Stanford University, California, USA, and at the National Cancer Centre Singapore, before joining Ionis Pharmaceuticals and Eli Lilly working on cancer drug and biomarker discovery programs. He also has commercial experience with biotech including Roche Diagnostics and Thermo Fisher Scientific in the areas of cellular analysis, applied markets and bioproduction.

Delia

Senior R&D Scientist, Merck

Cell Culture Media Designed for Intensified Perfusion Processes

Content

Current market needs are driving the interest of the industry towards the application of intensified processes and continuous manufacturing. Most commonly intensified processes include the application of perfusion technology, which facilitates the accumulation of very high cell densities (>50x106vc/mL) in the bioreactor. The accumulation of biomass can be applied as a scale up bioreactor or to increase volumetric productivity in the production bioreactor. The increased volumetric productivity allows using smaller bioreactors and consequently decreases the capital investment in a plant. However, in order to maintain high cell densities, cell culture media needs to be exchanged continuously and it is currently considered the highest expenditure in an upstream continuous process. Optimization of cell culture media that results in lower perfusion rates will drive the cost of the upstream process significantly down.

In this work, we applied an integrated design approach that includes nutritional fundamentals, design of experiments and multivariate analysis to formulate a new chemically defined perfusion medium. This perfusion medium was developed using multiple CHO cell lines and proteins to ensure broad spectrum applicability. In addition, this perfusion medium has been evaluated for several perfusion applications that include seed train bioreactor, steady state perfusion and other protein production modalities.

Biography

Delia Lyons is a Senior R&D Scientist in Process Solutions at Merck KGaA. In her current role she manages the PD lab and perfusion systems in Saint Louis. Delia has 14 years of industrial experience in which she has gathered extensive knowledge in cell culture media development and optimization for fed-batch and perfusion systems.

After completing her master degree in biotechnology at the University of Barcelona, Delia spent 2 years at the Chemical Engineering Department at MIT working in animal cell culture in fed-batch and perfusion modes. During the rest of her career, first at GIBCO and now at SAFC Process Solutions, she has specialized in cell culture media development and process development at the bench-top bioreactor scale. Her current team at Merck KGaA is responsible for the development of catalog and custom perfusion cell culture media products.

David Han

Head of Upstream & System RD China, Merck

Overcoming Challenges of Cell Line Development

Content

CHO cells with their unique characteristics, represent the major expression system within the biopharmaceutical industry. However, till today one of the major challenges in cell line development is to identify those rare, high-producing clones in a huge population of non-expressing or low-expressing cell lines. This leads to laborious and time consuming cell line development processes. Additional challenges are to find clones that provide stable high titer production over >60 generations.

In this presentation we will provide insights about challenges faced with traditional expression systems and how the CHOZN-GS cellline with the glutamine synthethase knock-out via Zinc Finger Nucleases provides benefites for fast and efficient cell line development as well as stable and high titer expression.

Biography

David Han is the head of Upstream & System RD China at Merck. He is responsible for customized media development and process development in biologics areas and vaccine areas. He has more than ten years of industrial experience in biopharmaceutical industry, especially in CHO based recombinant protein drugs production from cell line generation to large scale production. Prior to joining Merck in 2014, David worked in AutekBio as the director of upstream process development and led a dozen of projects development. He obtained his PhD of Biotechnology and Pharmaceutical from Chinese Academy of Sciences, and his Bachelor of Biology from Shandong University.

问题征集

会议酒店地址

会议酒店：上海浦东嘉里大酒店 大宴会厅（三楼）

浦东新区花木路1388号

交通：地铁7号线花木路站（5口出）

报名方式

1）您可以拨打电话或发邮件至会务负责人，在获得确认后，即可参会。

董甜甜（13716483322 ）   

E-mail：tiantian.dong@merckgroup.com 

2）或联系如下销售人员。

王润江（180 0116 3697）   

E-mail：jones.wang@merckgroup.com

李铖龙（158 2138 1219）   

E-mail：gavin.lee@merckgroup.com

余 超（138 1887 2708）   

E-mail：gin.yu@merckgroup.com

雷 杰（189 2516 2450）  

E-mail：leo.lei@merckgroup.com

会议报名回执

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