|
Conference Day One - 5 Sept 2007
|
| 08.00 | Registration and refreshments
|
| |
|
| 08.45 | Organiser's welcome remarks
|
| |
|
| THE BIOPHARMACEUTICAL BUSINESS OF CHINA |
|
| 09.00 | Keynote: The evolution of biopharmaceutical manufacturing
- The history and evolution of biopharmaceutical manufacturing
- Driving forces, technology innovations, future trends of biopharmaceutical manufacturing
- Will China become a future biopharmaceutical manufacturing
hub for the world? |
| |
|
| 09.30 | Panel discussion: Biopharmaceutical manufacturing opportunities and challenges in China
- Moving your manufacturing plants into China: what are the market opportunities, challenges and regulation restrictions: comparative analysis vs India
- Assessing local biopharmaceutical manufacturing developments and the technological gaps
- Availability of talents and where do you find them?
- Logistics and infrastructure readiness
- Outsourcing trends and drivers in China: what do you need to know
|
| | Sarah E Frew, Research Associate, Program on Life Sciences, Ethics and Policy, McLaughlin Rotman Centre for Global Health, UHN|UCMM, University of Toronto, Canada Ni Jian, CEO and Chief Scientist, Human Antibodomics, China Sun Li, Managing Director, Amoytop Biotech, China Ker Yin Lee, Executive Deputy General Manager, Shanghai United Cell Biotechnology, China
|
| GOOD MANUFACTURING PRACTICES, OPTIMIZATION, STANDARDS,
SAFETY & QUALITY I |
|
| 11.00 | Achieving quality and quantity by design in process
development for recombinant proteins, antibodies and gene
therapies
- Building biologic product quality by design in process development
- Implementing robust traceable processes through development
- Compare and contract design issues for recombinant biotherapeutics, antibodies and gene therapies
- The status of contract manufacturers in the US and what is expected from future CMOs of China
|
| | Jian Wei Zhu, Associate Director, Biopharmaceutical Development Program, SAIC Frederick, National Cancer Institute at Frederick, USA
|
| 11.30 | Strategies and tips for Chinese firms preparing for US FDA
inspection
- Understand why US FDA inspection is both necessary and desirable
- Gain an overview of the US FDA inspection process
- Find out the potential problem areas US FDA inspectors look for
|
| | Lei Zhang, Head of China Office, Biologics Consulting Group, China
|
| GOOD MANUFACTURING PRACTICES, OPTIMIZATION, STANDARDS,
SAFETY & QUALITY II |
|
| 12.00 | Networking luncheon
|
| |
|
| 13.30 | Assessing gaps between China and global GMP standards
and developing strategies in meeting global GMP standards
in China
- What’s the difference between China GMP and international GMP
- What’s the status of GMP compliance in China now?
-
A case study: Strategies implemented to help Tianyuan become GMP compliant to international standard |
| |
|
| 14.00 | Improving product safety: pathogen reduction using purpose designed affinity adsorbents
- Requirement for improved techniques for the removal of trace impurities and pathogens
- Ligand library screening to identify and select compounds with binding for specific impurities and pathogens
- Identifying ligands with a high affinity for prion proteins and host-cell proteins
- Reducing the risk of prion transmission via biological products derived from human or animal sources
|
| | Steve Burton, Chief Operating Executive, Prometic Biosciences, United Kingdom
|
| 14.30 | Speed networking sponsored by Emerson Process Management
Much like speed-dating, through a rotating cocktail table format, you will get the opportunity to meet all your fellow attendees face to face in just 30 minutes. Bring plenty of business cards along for a fast and furious interactive session. |
| |
|
| 15.00 | Afternoon refreshments
|
| |
|
| RAPID SCALE-UP PRACTICES FOR FERMENTATION AND CELL
CULTURE |
|
| 15.30 | Optimizing cell culture process development for vaccine
production
- The cell culture process development challenges for a new vaccine
- The evolution of cell culture in vaccine production
- Impact of disposable technology on facility design, start-up and validation of a cell culture facility
- Crystal balling the future of cell culture based vaccine production in China
|
| | Jonathan Liu, Director, Cell Culture Development, MedImmune, USA
|
| 16.00 | Implementation of disposable systems in cell culture for
antibody production
- Current trends of using disposable and single-use systems in bioprocess
- A case study of using disposable bioreactors for therapeutic antibody production
- Comparison of the disposable system with stainless steel
bioreactor |
| | Feng Li, Senior Engineer, Process Development, Genentech, USA
|
| 16.30 | Current status of large scale monoclonal antibody process development and production in China
- China's current manufacturing capacity and capability for monoclonal antibodies production
- Implementation of modern scale-up manufacturing practices in China and its impact on the industry
- A case study of setting up a world class antibody production facility in China
|
| | Hao Wang, Deputy Director, Cancer Institute of the Second Military Medical University, China
|
| 17.00 | Panel discussion: Implementing modern scale-up and processing technologies
to achieve efficient quality production in China
- Overcoming scale-up issues in downstream processing: Novel approaches of process design to decrease time and cost
- Implementing Process Analytical Technology (PAT) in China
- Reality and optimization: Implementing manufacturing technology scale-up from lab to commercial scale
- Product throughput and viral clearance
|
| | Feng Li, Senior Engineer, Process Development, Genentech, USA Joe Zhou, Scientific Director, Process Development, Amgen, USA
|
| 17.15 | Chairman's closing remarks
|
| |
|
| 17.30 | Networking cocktail
|
| |
|
|
Conference Day Two - 6 Sept 2007
|
| 08.00 | Registration and refreshments
|
| |
|
| 08.50 | Chairman's opening remarks
|
| |
|
| ADDRESSING BOTTLENECKS IN DOWNSTREAM PROCESSING |
|
| 09.00 | Development and future of biopharmaceutical processes
- The challenges of developing better products faster and at a lower cost
- New and emerging technologies to allow for a risk-based approach to product development
- The regulatory pathway for harmonizing global product development, regulatory submission and quality
|
| |
|
| 09.30 | Downstream processing 2007: From old paradigms to
sustainable standards
- Initial recovery: keeping the pace with fermentation
- Capturing: debottlenecking chromatographic unit operations
- Polishing: integrated concepts throughout the process
- Virus safety: new guidelines provide chances, not threats
- Process economy: disposables ways out of the fixed-cost trap
|
| | Uwe Gottschalk, Vice President, Purification Technologies, Sartorius Biotech, Germany
|
| 10.00 | Case Study: Development of downstream process for commercial monoclonal antibody development
- Current practice of viral clearance in downstream processing
- Scale-down model versus large-scale process
- Challenges of high titer cell culture compared with operations of low titer cell cultures in the past
|
| | Joe Zhou, Scientific Director, Process Development, Amgen, USA
|
| 10.30 | Morning refreshments
|
| |
|
| MANUFACTURING NEXT GENERATION THERAPIES IN CHINA |
|
| 11.00 | Addressing challenges in developing and manufacturing of
modern vaccines in China
- Modern technical approaches to address processing challenges
- Fermentation based vaccine manufacturing technology and disposable platforms
- Addressing particular challenges in downstream processing
|
| |
|
| 11.30 | Developing and producing biosimilar and recombinant protein therapeutics in China
- Biosimilar drug industry development and market promises in China
- Overview of regulations for biosimilars to register and market in China
- Best practices to yield quality recombinant protein therapeutics in processes
- The future of biosimilar products from China
|
| | Sun Li, Managing Director, Amoytop Biotech, China
|
| 12.00 | Modern development and production of antibody therapeutics
in China
- From antibiotics to antibody: China’s antibody industry evolution and current landscape
- Developing technology competency for antibody R&D and manufacturing in China
- The future of the antibody industry
|
| | Ni Jian, CEO and Chief Scientist, Human Antibodomics, China
|
| 12.30 | From generics to innovation: Our Chinese experience
- Why innovation, why now, why United Biotech
- The narrow and winding road to innovation
- Looking ahead – opportunities and challenges
|
| | Ker Yin Lee, Executive Deputy General Manager, Shanghai United Cell Biotechnology, China
|
| 13.00 | Networking luncheon
|
| |
|
| 14.00 | Enabling Operational Excellence to optimize plant performance
- Enabling operational excellence - Connecting the intelligent life science plant
- Optimized manufacturing process and optimized production process
- Automation and business integration for plant efficiency
|
| | Patrick Deruytter, Director, Engineering Services, Asia Pacific, Emerson Process Management, Singapore
|
|
|
| OUTSOURCE YOUR BIOPHARMCEUTICAL MANUFACTURING TO
CHINA |
|
| 14.30 | China’s bio-manufacturing outsourcing opportunities and
challenges
- CMO market overview
- Outsourcing supply and demand
- Outsourcing trends and strategies
- Biotechnology outsourcing to Asia
|
| |
|
| 15.00 | Panel Discussion: Outsourcing bio-manufacturing to China: Critical issues when selecting a CMO and managing quality while outsourcing
- Gain critical insight into contract manufacturing capacity and capability in China
- Understand opportunities for process development and testing in China
- Identify the competitive advantages and challenges of contract manufacturing of biologics in China
- Learn the critical evaluation criteria for selecting the best CMO partners and CMO views on setting realistic expectations and goals for win-win relationships
- Learn how to protect your IP rights and what CMOs in China are doing to help their clients prevent piracy
- Understand how to monitor the manufacturing process to ensure compliance with your corporate product safety and quality standards
|
| |
|
| 15.45 | Afternoon refreshments and China CMO showcase
|
| |
|
| 16.45 | Chairman's closing remarks and book prize draw
|
| |
|
| 17.00 | Close of congress
|
| |
|
|
Post-conference masterclass - 4 Sept 2007
|
| 08.30 | Registration
|
| |
|
| 09.00 | Gain US market access with the right US
FDA drug approval strategies!
USA alone accounts for 55% of the world drug expenditure. The unreasonable high price of biologic drugs on the US market has been the driving force behind the US congress evaluating new laws to pave the way for affordable versions of biologic drugs through biogenerics and the development of alternate drug sources.
Are you a Chinese pharmaceutical looking to penetrate the lucrative US biologics market? This Masterclass is designed to provide you with a rational strategy and a clear understanding of US FDA regulations to help you take advantage of this golden opportunity for Chinese biomanufacturers to fill the great demand for affordable and high quality biologic drugs. An ex-FDA suit will show you how!
Key topics:
1) US FDA requirements and processes for approval for biologic drugs
2) Strategies for developing the right biologic drugs for the US market
3) In depth coverage of technical issues for the manufacturing of monoclonal antibodies (which account for 65% of all biologic drugs in US)
4) Understanding ICH S6 guide for preclinical studies for biologics
5) Basics of cGMP, GLP and preparation for US FDA inspection
6) Immunogenicity issues in biologic drug development
7) Qualification and validation of assays
8) Strategically plan for manufacturing biologic drug for each phase of clinical trials (discussion of scale up, comparability issues) |
| |
|
