Discover the future of bioprocessing
in the Asian market.
On June 21, 2016, Finesse will host its third CellWorld Shanghai Forum at the InterContinental Shanghai Pudong, located at Pudong’s Lujiazui Finance and Trade Zone. This forum was created as platform for biopharma leaders to discuss the future of the Asian biopharmaceutical industry and to share the lessons learned during their experience in Asia.
Key speakers from Asia and the U.S. will present and discuss the changing landscape of the biopharmaceutical industry in Asia, industry trends, and regulatory requirements. Presentations will include case studies in process development, and design and engineering companies will discuss design and construction of manufacturing facilities. Finesse will introduce innovative solutions for both upstream and downstream single-use bioprocessing with the use of novel measurement, automation, and manufacturing execution systems (MES).
|8:00||Conference registration opens 大会注册|
|9:00||Welcome and introduction 致欢迎辞和会议介绍|
|9:15||Made in China 2025 and The Biopharma Industry Keynote
~ Chris Chen, PhD, CEO, WuXi Biologics
陈智胜博士, 总裁, 药明生物
|9:45||Korea Biotech Vision 2016 Keynote
~ Kevin Keebung Rhee, PhD, Chief Researcher, Biofors Global Inc.
이기붕 (李基朋)博士, 首席研究员, Biofors Global Inc.
|10:15||Technology showcase and morning tea 技术展示和茶歇|
|10:45||Continuous Processing in Asia: Today, Tomorrow Keynote
~ Barbara Paldus, PhD, CEO, Finesse Solutions
Barbara Paldus博士, 总裁, 飞翔科技
|11:15||The Changing Landscape in Bioprocessing Panel Discussion
~ Chris Chen, PhD, Kevin Keebung Rhee, PhD, Mr. Rolf Blumenthal,
~ Barbara Paldus, PhD (Chair)
陈智胜博士, 李基朋博士, 罗尔夫 布鲁门塔尔
|13:30||Alvotech SmartFactory Case Study
~ Barbara Paldus, PhD, CEO Finesse Solutions
Barbara Paldus博士, 总裁,飞翔科技
|14:30||Moving Toward a SmartFactory with MES Case Study
~ Mr. Rolf Blumenthal, Senior Director Business Unit MES,
Werum IT Solutions GmbH
罗尔夫 布鲁门塔尔先生, MES业务高级总监, Werum IT Solutions GmbH
|15:00||Process Scale-Up and Technology Transfer
Using Single-use Technology Case Study
~ Ting Chen, PhD, Team Leader, AlphaMab Co., Ltd
陈亭博士, 项目总监, 康宁杰瑞生物
|15:30||Technology showcase and high tea 技术展示和茶歇|
|16:00||Online OUR Measurement in Cell Culture Process Development Case Study
~ Hang Zhou, PhD, Director of Cell Culture Process Development,
周航博士, 细胞培养工艺开发部 主任, 药明生物
|16:30||Biopharmaceutical Engineering Project Implementation Case Study
~ Mr. An Liu, Vice President, Tried Technologies Co., Ltd.
刘安先生, 执行副总, 创洁科技
|17:00||Ask Service Engineer System Clinic
|17:45||Closing remarks cocktails and dinner
Introducing the Speakers
Dr. Chris Chen is currently chief executive officer of WuXi Biologics (a business unit of WuXi Apptec), leading a 1000-member biologics service team in China. At WuXi Dr. Chen has built a world-class open-access integrated mAb discovery, development and manufacturing platform to service needs from global clients.
The Chinese government recently released the Made in China 2025 Initiative (MiC2025) to upgrade from low cost manufacturing to innovation and manufacturing efficiency. Dr. Chen will share his view on how MiC2025 will impact the biologics industry and biologics companies in China, and the new regulatory requirements needed to upgrade and meet global standards.
Dr. Kevin Keebung Rhee is chief researcher at Biofors Global Inc. Dr. Rhee leads an engineering team with expertise in turn-key bioprocessing management, delivering cost-effective solutions to biopharma companies.
Ten years ago, the Korean government announced its biotechnology plan, Bio-Vision 2016, which documented the goal to make South Korea one of the world’s top biotech nations by 2016. Dr. Rhee will discuss the status of Korea’s biotech industry in 2016 and how large Korean companies, such as Samsung and LG, play in the biopharma industry.
이기붕 (李基明) 博士是韩国Biofors Global Inc.公司首席研究员。李博士领导着一支专业的工程师团队，为生物医药公司提供具有成本优势的整体生物工艺解决方案。李博士的演讲将向大家介绍2016年韩国生物产业的发展现状和一些大公司（三星、LG）在产业中发挥的作用。
Dr. Barbara Paldus is currently chief executive officer of Finesse Solutions, Inc. She co-founded the company with Dr. Mark Selker in 2005 and today Finesse operates in over 20 countries with 125 people. Finesse is leveraging Silicon Valley’s innovation culture to develop revolutionary single-use sensors and SMART automation platforms to make customers’ bioprocess excellent.
Dr. Paldus will chair the panel discussion on the changing landscape in bioprocessing. Dr. Paldus will also share her view on how continuous processing can be implemented in Asia and provide instrument examples with different perfusion mechanisms. And finally, she will share experiences and lessons learned in the deployment of the first SmartFactory single-use manufacturing facility developed by Finesse for Alvotech in Iceland. The SmartFactory solution provides efficient facility implementation for biosimilar or vaccine development. Alvotech is one of the most forward thinking biosimilar manufacturing companies that has recently invested in single-use and SMART technology, from design to commissioning of the facility.
Barb Paldus博士担任飞翔科技公司总裁，她和Mark Selker博士在2005年共同创建公司，至今飞翔科技的业务地区已超过20个国家。公司凭借硅谷创新文化已成功开发具有革命性的一次性传感器和SMART自动化平台，帮助客户实现了卓越生物工艺水平。Barb将主持小组讨论与大家共同探讨变革中的生物工艺格局。
Mr. Rolf Blumenthal is senior director of the MES business unit and member of the extended management board responsible for business development in China at Werum IT Solutions GmbH. He has also been a steering committee member of the GAMP Forum for more than 15 years.
Mr. Blumenthal will discuss why data integrity and electronic records is key to providing reliable single-use GMP manufacturing data. How it will improve the economics of implementing products release by exception while meeting regulatory requirements through MES solutions.
罗尔夫 布鲁门塔尔先生在德国Werum IT Solutions GmbH公司担任高级副总监，负责公司MES业务在中国的市场拓展。Blumenthal 先生的报告将讨论为什么数据完整性和电子记录对基于一次性技术GMP生产的数据起到关键作用，如何通过MES在提升产品经济性的同时满足监管要求。
Dr. Ting Chen, of Alphamab Co. Ltd, leads a team of scientists working on cell culture process development and scale-up to GMP manufacturing processing. He also works with the manufacturing team on building a new GMP manufacturing facility.
Dr. Chen will present how they use single-use technology for process scale-up and transfer the process to manufacturing facilities across several provinces. His team develops processes in small glass vessels as well as larger single-use vessels. The GAMP manufacturing facility is using single-use technology.
Dr. Hang Zhou is director of cell culture process development at WuXi Biologics. He leads a team of perfusion process development for biologics including recombinant proteins and mAbs, from scale-down models to scale-up and GMP production (clinical).
Dr. Zhou will discuss the concept of OUR and the use of online OUR measurement and its application in cell culture process development. He will also share his view on how OUR potentially can be automated using advanced application software.
Mr. An Liu is vice president of sales at Tried Technologies Co., Ltd., an engineering company focus on the biopharma industry in China.
Mr. Liu will share Tried Technologies’ experiences in building a GMP production facility. He will walk through typical project implementation models (EPC/EPCM/DB) for a GMP facility from design, to engineering, to finally building and commissioning the facility, while also covering practical risks and design and construction issues of biopharmaceuticals engineering projects.