 |
 |
|
BioProcess International™ Conference & Exhibition Asia Pacific
2007年10月31日（水）〜11月2日（金）
韓国 グランドインターコンチネンタルソウル
スケジュール
Pre-Conference Seminars
Wednesday, October 31, 2007
| DAY ONE | DAY TWO | |
| Pre-Conference Seminar I: Biosimilars/ Follow-On Biologics |
| 8:00 | Registration & Morning Coffee |
| Market Landscape of Biosimilars/Follow-on Biologics |
| 8:30 | Chairman's Opening Remarks
Laureen Little, Ph.D., Principal Consultant, Editor/Publisher, BioQuality |
| 8:40 | Introduction of the Landscape and Regulatory Update on Biosimilars/Follow-on Biologics
Although industry discussions about biosimilars/follow-on biologics have been discussed in the biopharmaceutical arena for well over a decade, it has only been recently that regulators within Europe have opened up a regulatory pathway for obtaining marketing authorization of these products. Meanwhile, the US FDA is still struggling with establishing an approval pathway or indeed whether such a pathway should even exist. Establishment of any new pharmaceutical approval pathways within the US is the result of a somewhat tortuous process which includes "discussions" between the FDA, the US political representatives and Industry organizations. This talk will provide a background of existing regulations as well as an update of the "discussions" between the three critical players.
Laureen Little, Ph.D., Principal Consultant, Editor/Publisher, BioQuality |
| 9:10 | Development of First Biogenerics for Monoclonal Antibody: The ISU Abxis Approach
ISU Abxis has developed and successfully launched therapeutic antibody, Clotinab® which is a biogenerics of ReoPro®, first in Korea. The Abxis approach, which has focused on cell culture process development using WAVE bioreactor to reduce time and cost for manufacturing while keeping product comparability for successful development, will be presented.
Heungrok Park, Ph.D., Director of Research, ISU Abxis Co., Ltd. |
| 9:40 | Creating Competitive Advantage through Biogenerics - the Shantha Biotech Experience
Abstract to come.
Ranajit Sen, Assistant Vice President, Business Development, Shantha Biotechnics Ltd. |
| 10:10 | Morning Refreshment Break |
| Analytics of Biosimilars |
| 10:40 | Glycan Mapping for Biogenerics
Erythropoietin and some antibodies are the obvious examples since specific glycan structures are important for bioactivity and variations in glycan structures will occur and be affected from production source and conditions. We had just finished a small survey and practical bench marking on glycan mapping technology in some UK pharmaceutical companies and control labs on how often and what methods they normally used. Interesting and important information are obtained and we are now expanding this exercise with the USP to a wider audience. The eventual goal is to make recommendations and guidance to both industry and regulatory bodies on how to setup meaningful procedures for the characterisation and monitoring of quality of glycoprotein products.
Chun-Ting Yuen, Ph.D., Senior Scientist, Lab for Molecular Structure, National Institute for Biological Standards and Control |
| 11:10 | Analytical Characterization and Comparability of Biosimilar Drugs
Experience in the use of different analytical tools for the characterization of Biosimilar drugs and for studying comparability with different marketed products will be shared. Sensitive techniques have been developed to characterize and compare the impurity profiles and product related substances. Biological activity is compared through a variety of In vitro and in vivo biological assays. Data from comparative analysis of several Biosimilar drugs will be presented.
Dhananjay Patankar, Ph.D., Chief Technology Officer, Intas Pharmaceuticals, Inc. |
| 11:40 | Analytical Methods for Process Residuals in Biotechnology-Derived Products
The assessment of process residuals is one of the key considerations in the development of both innovator and follow-on biological products. Purification steps are incorporated to clear, or minimize, process residuals in the final drug substance. But the data depends upon the ability of several different analytical test methods to accurately, precisely and reliably measure specific process residuals. This talk will define the types of analytical assays that are typically used to test for biotechnology process residuals, and discuss critical technical elements to be considered in the selection and validation of process-defined test methods such as host cell protein ELISAs.
Nadine Ritter, Ph.D., Senior Consultant, Biologics Consulting Group, Inc. |
| 12:10 | Roundtable Discussion Innovation and Biogenerics - Can it Go Together?
- What are the issues related to development of innovative drugs vs. biogenerics?
- How do you deal with protecting your innovation on the one hand, but also getting into biogenerics on the other?
Speakers of the Day |
| 1:00 | Close of Pre-Conference Seminar I
|
| Pre-Conference Seminar II: Antibody & Protein Development & Engineering |
| 1:00 | Registration |
| 2:00 | Chairperson's Opening Remarks
Junho Chung, M.D., Ph.D., Associate Professor, Seoul National University College of Medicine |
| 2:10 | Fc Fusion Proteins in the Development of Novel Anti-Inflammatory Therapeutics
While therapeutic proteins offer high target specificity, protein stability often leaves much to be desired. One method of increasing stability is to fuse the protein to a stable protein domain, such as the immunoglobulin Fc region. Although an easy fix, it can create its own problems, some of which will be discussed.
Sangho Park, Ph.D., Project Leader, IsuAbxis |
| 2:40 | Protein-based New Drug Discovery & Development Using Macromolecular Intracellular Transduction Technology
In our previous study with cell-permeable Cre and SOCS3, we demonstrated the first use of Macromolecule Intracellular Transduction Technology (MITT) to treat life-threatening diseases such as inflammation and cancer (Jo et al., (2001) Nature Biotechnology & Jo et al., (2005) Nature Medicine). Based on these scientific achievements, the latest advance of MITT and its wide application in new drug discovery/development will be discussed.
Daewoong Jo, Ph.D., Founder & Chief Executive Officer, Procell Therapeutics Inc. |
| 3:10 | Case Study of Development of Thrombopoietin
There has been a highly unmet medical need for many years for the treatment of thrombocytopenia. This presentation will describe 3SBio's experience in development of thrombopoietin, a megakaryocyte stimulator which is responsible for the production of platelet. We will review the preclinical efficacy and toxicity studies in mice, rats and rhesus monkeys and clinical study in patients with chemo-therapy induced thrombocytopenia and Idiopathic thrombocytopenic purpura.
Dongmei Su, MSc., Chief Technology Officer, Shenyang Sunshine Pharmaceuticals Co., Ltd |
| 3:40 | Afternoon Refreshment Break |
| 4:10 | Antibody as a Scaffold Displaying Peptide Motif
The placement of bioactive and or binding peptides within an antibody scaffold or their generation within the scaffold provides for the rapid development of immunological agents that can be used as biological tools or therapeutics. Often peptides themselves have compromised activity in vivo, and their binding may be difficult to monitor. However, their display within the context of an antibody addresses detection problems as well as problems associated with proteolysis of peptides and their rapid clearance since antibodies and antibody fragments exhibit relatively predictable pharmacokinetic behavior. Where it is desirable, for example, in a cancer setting, the Fc region of the antibody can bestow cell-killing properties onto the peptide sequence as a result of immune effector coupling. We believe that this approach can be applied to a wide range of peptides with binding activity to rapidly generate useful immunological reagents.
Junho Chung, M.D., Ph.D., Associate Professor, Seoul National University College of Medicine |
| 4:40 | Antibodomic Approach to Discover and Develop Novel Antibody Targets and Fully Human Antibody Leads
We are developing an antibodomic program that leads to discovery and development of novel antibody targets and fully human antibodomic medicines. New technologies are increasing the speed and efficiency of fully human antibody development. Several novel antibody targets and Antibodomic Medicines, such as human monoclonal antibody against a novel tumor target HAI-TMIP and first fully human monoclonal antibody against HBV and HIV, will be discussed.
Jian Ni, Ph.D., CEO and Chief Scientist, Human Antibodomics, Inc. |
| 5:10 | Interview with CEOs - 30 minute interview with CEOs of emerging antibody companies in Asia
Moderators:
Junho Chung, M.D., Ph.D., Associate Professor, Seoul National University College of Medicine
Guoliang Yu, Ph.D., Chief Executive Officer, Epitomics, Inc.
Panelists:
Changhoon Choi, Ph.D., Chief Executive Officer, ISU Abxis
Cheng Liu, Ph.D., Chief Executive Officer, Eureka Inc.
Jian Ni, Ph.D., 2 Human Antibodomics, Inc.
Jing Lou, M.D., Ph.D., Chief Executive Officer, Shenyang Sunshine Pharmaceuticals Co., Ltd
|
| 5:40 | Close of Pre-Conference Seminar II |
Main Conference - Day One
Thursday, November 1, 2007
| PRE-CONFERENCE SEMINARS | DAY TWO | |
| 8:00 | Registration & Morning Coffee |
| 8:30 | Chairperson's Opening Remarks
Scott M. Wheelwright, Ph.D., President And CEO, Strategic Manufacturing Worldwide, Inc. |
| | Keynote Presentation |
| 8:40 | Contract Manufacturing and the Economics of Biopharmaceutical Development
Bioprocess economics have changed as a result of process convergence and the uncertainty of new product success. Improved bioprocessing technologies allow construction of manufacturing facilities applicable to many biopharmaceuticals. Regulatory stringency and reduced effective product lifetime have reduced the probability of economic return from new biopharmaceuticals. These effects increase the overall economic advantages of biopharmaceutical contract manufacturing to the industry and society.
Donald F. Gerson, Ph.D., Chief Operating Officer & President, Celltrion Inc. |
| Regulatory, IP & Compliance |
| 9:10 | Featured Presentation Global Regulatory Challenges For Biotechnology Products
This presentation will discuss regulatory strategies for global licensure and manufacture of biological therapeutics. key areas of focus will include current challenges in the areas of differing worldwide technical and gmp standards, varying requirements for in-process controls and product specifications as well as the resulting complexities to supply chain and innovation.
Wassim Nashabeh, Ph.D., Director, Regulatory Affairs, Genentech Inc. |
| 9:40 | Global Intellectual Property Challenges for Biotechnology Products
Intellectual property (IP) and regulatory exclusivities are essential for the development and commercialization of innovative biologics and yet the pathways for obtaining IP protection for and regulatory approval of biologics, including antibodies, are not straightforward. This presentation will discuss IP strategies for biologics in view of significant patent law changes and regulatory reforms, including for follow-on biologics/biosimilars.
Janet McNicholas, Partner, Bell, Boyd & Lloyd LLC (IP) |
| 10:10 | Efficient and Effective cGMP Program during the Drug Development
cGMP regulations are minimum requirements for manufacturing of drug products regardless of their stage of development. However, due to the nature of drug development processes and associated business risks, an efficient and effective cGMP work processes should be designed and implemented to accommodate evolving process/product knowledge while minimizing the business risks and assuring product quality, safety and efficacy.
Brian Kim, Ph.D., Vice President of Quality, Tanox, Inc. |
| 10:40 | Morning Refreshment Break and Opening of Exhibit Hall |
| Large Scale Manufacturing & Contract Outsourcing |
| 11:10 | Role of Asia in Biomanufacturing as Part of Global Initiative for Cost-Effective Biopharmaceutical Development
Biopharmaceuticals are becoming an important class of therapeutic agent especially against cancer and immune diseases. However, the cost for treatment for this class of therapeutic agent is beyond the reach of majority of people in the world today. The need to develop biopharmaceuticals cost-effectively becoming more important and Asia could play an important role in reducing the cost of development. The opportunities and challenges for completing the value chain from biologics development in the western hemisphere to manufacturing in Asia will be part of the presentation. The paper will also explore some potential collaborative models that can be adopted that will help enhance the role of Contract Biomanufacturing Companies in Asia.
Mohd Nazlee Kamal, Ph.D., Chief Executive Officer, InnoBiologics S/B |
| 11:40 | Opportunities and Challenges in Outsourcing Biopharmaceutical Manufacturing
The opportunities for companies that are developing biopharmaceuticals to outsource their biopharmaceutical manufacturing are increasing as more players enter the market, which is driven by the increase in the number of biopharmaceuticals moving towards commercial sale. In this presentation we will walk through the anatomy of a typical outsourcing project, describing real life examples of the different challenges faced in moving a project from concept to full scale practice. We will also explore the players in the CMO market in Asia and highlight specific opportunities for client companies and vendors in this expanding arena.
Scott M. Wheelwright, Ph.D., President & CEO, Strategic Manufacturing Worldwide, Inc. |
| 12:10 | Large Scale Manufacturing of Kogenate™ - The Largest Recombinant Protein Made in Biopharmaceutical Industry
rFVIII is a therapeutic protein for the treatment of Hemophilia A, which is an X-linked recessive bleeding disorder that affects 1 in 10,000 males throughout the world. rFVIII is a human protein with 2332 amino acids and a molecular weight of more than 300 KD. So far the rFVIII is the largest protein genetically engineered by biotech industry. Due to the complexity and instability of the protein, there are many difficulties and challenges to manufacture rFVIII. This presentation provides a broad view of how Bayer has manufactured the rFVIII in the past decade. It covers the characteristics of rFVIII molecule; challenges in manufacturing processes, key process technologies and complexity in quality assurance and quality control system. At the end, a new generation of Kogenate™ currently in clinical development is also introduced and discussed.
DQ Wang, Ph.D., Department Head, Formulation, Freeze-Drying and Delivery, Bayer Healthcare |
| 12:40 | Networking Luncheon |
| 2:00 | Chairperson's Opening Remarks
Siddharth J. Advant, Ph.D., Director, Project Management, Diosynth Biotechnology |
| 2:05 | India's Vaccine Development, Regulatory Issues and Manufacturing Capabilities
Indian vaccine industry is traditionally driven by institutional procurement with low prices and unpredictable budgets. However, vaccine manufacturers shifted their focus towards global markets. Many companies have obtained WHO pre-qualification for supply of vaccines to UNICEF and other international agencies. Ability to produce high quality vaccines, low operational costs, a strong science base and low clinical trial costs are favoring India to become the global hub for vaccine development and manufacture. Changing regulatory environment and intellectual property regimes are attracting MNCs and foreign investments to India. Indian vaccine industry is focusing on late stage products rather than early stage vaccines which require huge R&D investments.. India is going to play a key role not only in supplying traditional childhood vaccines but also new combination and conjugate vaccines to global vaccination programs.
G.S. Reddy, BVSc., Chief General Manager, Indian Immunologicals |
| Disposables For Biopharmaceutical Manufacturing |
| 2:35 | Talk Title TBA
Speaker TBA |
| 3:05 | Integration, Implementation and Validation of Single-use Bioprocessing Technologies
Single use disposable technology is a proven alternative solution for the biopharmaceutical industry (upstream, downstream, formulation and filling) offering several significant advantages over standard reusable stainless steel systems. Key factors for successful single use system integration are:
- Process Knowledge
- Validation Support
- Experience with Single Use Systems
- Strong Technical Capability
- Single Use Product Portfolio offering
- Full Documentation Package
Ian Sellick, Director of Marketing, Pall Life Sciences |
| 3:35 | Afternoon Refreshment Break in Exhibit Hall |
| Technology Transfer |
| 4:05 | Benefits and Challenges of Technology Transfer Between the US and Chinese Companies
Bio-collaborations in drug development bring scientists from West and East together to offer a lot of advantages ranging from resources sharing, cost reduction and expediting development cycle. However, the establishment and management of collaboration poise challenges in the areas of intellectual property protection, cultural differences and quality standards. Epitomics Inc., a US based biotechnology company, has the first hand knowledge and experience on how to manage a collaboration through Chinese subsidiary with efficiency and how to avoid potential pitfalls before they occur.
Guo-Liang Yu, Ph.D., President and CEO, Epitomics Inc. |
| 4:35 | Role of Project Management During Technology Transfer to CMO's
Abstract to come.
Siddharth J. Advant, Ph.D., Director, Project Management, Diosynth Biotechnology |
| 5:05 | Cocktail Reception & Karaoke Night |
Main Conference - Day Two
Friday, November 2, 2007
| PRE-CONFERENCE SEMINARS | DAY ONE | |
| 8:00 | Morning Coffee |
| Cell Line & Cell Culture Engineering |
| 8:30 | Chairperson's Opening Remarks
Laurel Donahue-Hjelle, Ph.D., Director of Cell Line Development, Invitrogen |
| 8:40 | Key Issues Facing Cell Line Developers and Cell Culture Engineers
Cell line development and cell culture process development are complex and interdependent. Cell line developers face issues such as how to obtain and maintain expression stable expression, how to make development more reliable and how to improve existing lines that are suboptimal in performance but important commercially. Cell culture process development engineers face issues such as how to most rapidly optimize the best formulation for an individual line and how to develop regulatory, manufacturing and cost friendly formulations. In addition, decreasing timelines have placed pressure on these two groups that traditionally perform their functions in relative isolation to work in parallel. Some of the challenges and unexpected benefits of this change in the industry will be discussed.
Laurel Donahue-Hjelle, Ph.D., Director of Cell Line Development, Invitrogen |
| 9:05 | Antiapoptotic CHO Cell Engineering for Improved Therapeutic Protein Production
In large-scale, serum-free suspension culture for therapeutic protein production, CHO cells die mainly by apoptosis. Various strategies of antiapoptotic CHO cell engineering such as overexpression of antiapoptotic genes and down-regulation of effector molecules, eventually leading to improved protein production, will be discussed
Gyun Min Lee, Ph.D., Professor, Department of Biological Sciences, KAIST, Korea |
| 9:30 | Development of Recombinant Factor VIII from CHO Cell in Profusion Celture System Using Animal Source-Free Condition
Development of B-domain deleted rh-Factor VIII was accomplished in a animal source free condition except for the mouse antibody used for the immuno-affinity chromatography step. The CHO cell perfusion culture system was chosen to ensure the maximized production yield in the most cost-effective facility. The patented final formula does not contain albumin. We are also developing rh-Factor IX.
Chong-Hwan Chang, Ph.D., Executive Vice President, Head of R&D, Green Cross Corporation |
| 9:55 | Cornerstones of Pharmaceutical Cell Line Development
Depending on the product ProBioGen cell line development starts either from a unique CHO cell carefully preselected for production and process suitability or from a proprietary human cell line created by rational design. A proprietary vector family containing new fusion promoters with inherent elements preventing epigenetic inactivation, advanced selection strategies and the combination of manual and automated screening provide the basis for fast track development where candidate clones become available 4-6 weeks after transfection. An integrated approach facilitates downstream and assay development and allows for early glycoanalysis to asses clonal variations simultaneous with generic fed batch evaluation. A recombinase based gene exchange was incorporated into a CHO high producer to provide a tool for simple evaluation of multiple product candidates.
Volker Sandig, Ph.D., Vice President, ProBioGen AG |
| 10:20 | Morning Refreshment Break in Exhibit Hall |
| 11:00 | Systems Biology Approach to BioProcess Development—Development and Implementation of High Throughput Platform Technology
Systems Biology studies biological events as integrated systems by applying high throughput technology to systematically monitor, integrate and simulate biological and biochemical responses of the system that requires the application of Systems Biology approach to reveal useful process knowledge. High throughput technology is pre-requisite to such application. This presentation will discuss further details in application of the Systems Biology approach to bioprocess development, including high throughput technology development.
Shun Luo, Ph.D., Scientist, Late State Cell Culture Process Development, Genentech Inc. |
| 11:25 | Animal-Free Cell Culture Media Supplements- Challenges, Hurdles, and Solutions
As the Biotechnology industry continues its move away from using animal derived components to minimize risks, real or perceived, researchers are challenged to come up with suitable non-animal source supplements that can enhance or at least equal the cell culture performance. The talk will present case studies of replacing animal derived components with recombinant animal-free cell culture supplements. The effect of animal free cell culture supplements such as recombinant albumin on bioprocess applications of therapeutic protein production will be discussed. The data will demonstrate that the AF recombinant proteins offer all the advantages of the tried and trusted classical serum and albumin containing media with the added advantage of AF compliance.
Tariq Haq, Product Manager AF Supplements, Bioprocess Division, Millipore Corporation |
| 11:50 | Glycoprotein Production for Pharmaceutical Research
Modern pharmaceutical research requires large amount of aunthentic and biologically active glycoproteins for structural studies and/or high throughput screening. The successful production of these complex proteins depends on a collaborative effort from molecular/cell biologists, fermentation engineers and prtotein chemists. This talk describes some aspects of this development and production work which resulted in the 3D structure of the insulin and epidermal growth factor receptor ectodomains. Also, some of Australia's collaborative research facilities will be briefly described as well.
George Lovrecz, Ph.D., Senior Scientist, CSIRO Molecular and Health Technologies |
| 12:15 | Networking Luncheon |
| 1:30 | Chairperson's Opening Remarks
Mani Subramanian, Ph.D., Director, Center for Biocatalysis & Bioprocessing, and Professor, Chemical & Biochemical Engineering, University of Iowa, Iowa City, Iowa |
| Mammalian Expression |
| 1:35 | Beyond CHO-cells: Microbial Systems to Express Complex Proteins
Protein drugs are mostly produced in E. coli (simple proteins that does not require post-translational modification or assembly) or CHO cells (complex proteins such as antibodies, that require post-translational modification &/or assembly). The cost of production of proteins in CHO cells is at least 3-10X higher. In recent years, several "microbial and non-microbial expression systems" have been developed to express complex proteins in high yield. Some of these systems have been engineered to produce/secrete not only protein with multiple disulfide bonds, but also antibodies with 'humanized' glycosylation. Products from these new expression systems are in various stages of clinical trials. Broad-based adoption of these new protein expression systems will have a positive impact on the cost of production and hence, therapy.
Mani Subramanian, Ph.D., Director, Center for Biocatalysis & Bioprocessing, and Professor, Chemical & Biochemical Engineering, University of Iowa, Iowa City, Iowa |
| Purification & Recovery |
| 2:00 | Tocilizumab, a First-in-Class Humanized Anti-IL-6 Receptor Monoclonal Antibody
Abstract to come.
Kenji Wada, Ph.D., Head of Process Development, Chugai Pharmaceuticals |
| 2:25 | Closing the Bottleneck in Biopharmaceutical Downstream: Old Ideas and New Paradigms
While the gap between up- and downstream is widening and resources are becoming limited, the performance pressure on bioprocessing is steadily increasing. The presentation will focus on potential ways out of the technological dead-end street and will touch upon areas such as development of generic platform processes, robust and scalable unit operations and disposable manufacturing. New requirements in the area of virus and contaminant clearance will be highlighted and best practises will be substantiated with overall process cost models and simulation tools.
Uwe Gottschalk, Ph.D., Vice President, Purification Technologies, Sartorius Stedim Biotech |
| 2:50 | Advances in the Design and Development of Downstream Processes for Purification of Monoclonal Antibodies
This presentation will discuss the capability of existing and future chromatography formats to handle upcoming challenges in mAb purification from both a technical and economical perspective. Data on the optimization of specific unit operations such as initial capture by Protein A affinity chromatography and final polishing by novel resins of multimodal type will be included.
Hans J Johansson, Ph.D., Senior Scientist, Research & Development, GE Healthcare Bio-Sciences |
| 3:15 | Afternoon Refreshment Break in Exhibit Hall |
| 3:45 | New Directions in Downstream Processing for Non-Antibody Proteins
A common technology platform can be applied for antibody purification, however, for therapeutic proteins generally a case by case approach to downstream process development is required. Overall development timescales can be extended and transferable learning limited. New approaches emerging to overcome these bottlenecks for non antibody proteins include:
- Reassessment of alternative techniques to chromatography including aqueous two phase separation, crystallisation and precipitation
- Novel technical approaches to problems such as refolding
- Data mining to inform new process development.
- High throughput process development techniques
The potential for new approaches to protein purification to impact on the development timeline for biotherapeutics will be reviewed. The regulatory situation and learning from previous innovations in protein purification will be discussed.
John M Liddell, Ph.D., Head of Process Science, Avecia Biologics |
| 4:10 | Protein Folding Liquid Chromatography as a New Approach for Renaturation with Simultaneous Purification of Protein Drugs Sourcing from e. coli
Protein folding liquid chromatography simultaneously four functions, removal of charotropic agent, refolding of target proteins, separation from impure proteins, and easy to recovery the waste chaorotropic agent, resulting in the increases in its recovery of mass and bioactivity. The down-stream technology can be shorted and used in industrial scale.
Xindu Geng, Ph.D., Full Professor, Institute of Modern Separation Science, Northwest University |
| 4:35 | Speedy Generation of Monoclonal Antibodies
Monoclonal antibodies are considered as the future of the drugs for treatment of human diseases. We present here a high-through-put "One-stop Antibody Generation" platform which includes computer-added immunogen design, PCR-based cDNA cloning, recombinant protein expression & purification, and speedy mouse monoclonal antibody generation.
Le Sun, Ph.D., President & CEO, AbMax Biotechnology, Inc. |
| 5:00 | Close of Conference |
|
