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Monday | Tuesday Main Conference - Plenary Session
8:00
Registration and Coffee
8:50
Chairperson's Opening Remarks
Guo-Liang Yu, Ph.D., President & CEO, Epitomics Inc. Keynote Presentations
9:00
Pilot Plants, Capacity Planning, Outsourcing and Tech Transfer With an increasing number in biologicals development and manufacturing projects, and a given plant infrastructure, in house as well as external capacity planning is of utmost importance for the production of clinical and launch material. This presentation will summarize our approach for balancing internal pilot scale capacities with outsourcing, and will address critical issues related to internal and external tech transfer. Berthold Bödeker, Ph.D., Head Pilot Plants and Cell Culture, Bayer Healthcare AG
9:30
Vaccine Manufacturing & Development: A US FDA Regulatory Perspective This presentation will provide a regulatory perspective of the development of new vaccines for emerging and re-emerging disease, including vaccines against global diseases, which may possess unique product characteristics and are produced using new technologies. The regulatory pathways to facilitate the development of these products will be discussed. Marion F. Gruber, Ph.D., Associate Director for Regulatory Policy, Center for Biologic Evaluation & Research, Office of Vaccine Research & Review, Food & Drug Administration
10:00
Industry Leadership ForumOpportunities and Market Outlook for Biologics R&D and Process Development in ChinaModerator: Joe Zhou, Ph.D., CEO, ShineRun BioPharma Co., Ltd., Biopharmaceutical Division of Wison Group Panelists: Guo-Liang Yu, Ph.D., President & CEO, Epitomics Inc. Julius Zhiliang Li, MSc. MBA, Chief Executive Officer, Autekbio, Inc. Liangzhi Xie, Ph.D., President, Sinocelltech
11:00
Networking Refreshment Break and Opening of Exhibit & Poster Hall
Novel BioTherapeutics Case Studies
11:30
Novel Antibodies for the Treatment of Asthma
Abstract not available at time of print. Bing Yao (Zhenbin Yao), Ph.D., Director, Product Portfolio Management, Genentech Charlene Liao, Ph.D., Senior Early Development Team Leader, Product Portfolio Management, Genentech, Inc.
11:55
Development of Best-In-Class Therapeutic Antibodies Using Rabmabs
Abstract not available at time of print. Yaohuang Ke, Ph.D., Director of Antibody Engineering, Epitomics, Inc.
12:20
From Biochemical Drugs to Biologics
Techpool Biopharma has developed and manufactured biologics from human urine and other natural resources. The urinary trypsin inhibitor was ranked the best selling biochemical drug in China and urinary kallikrein was recently launched as an innovative drug. Recombinant forms of these biologics are produced using mammalian cell culture. Yongmin Hou, Ph.D., Chief Scientific Officer, Techpool Biopharma, China
12:45
Networking Luncheon in Exhibit & Poster Hall
Main Conference - Concurrent SessionsTechnical Session I:Cell Line Engineering & DevelopmentSession Chair: Jianguo Yang, Ph.D., Scientist and Group Leader, Cell Line Development, MedImmune LLC
2:00
CHO Stable Platform Cell Line Development: Balancing the Timeline and Productivity
The demand to move more drug candidates into clinical trials makes the speed and efficiency to develop stable cell lines for TOX and GMP material production critical. This talk will present the platform we developed to meet that demand and the challenges we have been facing to balance the timeline and productivity. Amy Shen, Ph.D., Scientist, Early Stage Cell Culture, Genentech, Inc.
2:25
A "GC-Rich" Method for Mammalian Gene Expression: A Dominant Role of GC-Rich DNA in Regulation of Mammalian Gene Expression
We have achieved extremely high mammalian gene expression for more than twenty different proteins and antibodies in different cell types by using just a few laboratory scale stable gene transfections for each protein. The stable expression vectors were constructed by inserting a naturally occurring 1.006kb or a synthetic 0.733kb NDA fragment of extremely GC-rich at the 5' or/and 3' flanking regions of these protein or antibody genes. This experiment is the first experimental evidence showing that a non-coding extremely GC-rich DNA fragment is a super "chromatin opening element" and plays an important role in mammalian gene expression. This experiment has further indicated that chromatin-based regulation of mammalian gene expression is at least partially embedded in DNA primary structure, namely DNA GC-content. Qian Jia, Ph.D., Deputy General Manager, New Drug R&D Co. Ltd. of North China Pharmaceutical Group Corporation
2:50
Engineering of CHO Cell Line for Expression of Human Antibody with Enhanced ADCC
ADCC (Antibody-Dependent Cell-mediated Cytotoxicity) is a major mechanism of action for therapeutic antibodies for treatment of cancer and autoimmune diseases. A novel approach has been developed through glycosylation engineering in mammalian cells (CHO) to produce antibodies with enhanced ADCC (10-100xfold), which has potential to dramatically improve clinical efficacy of antibody drugs. Cheng Liu, Ph.D., President & CEO, Eureka Therapeutics, Inc.
3:15
Overview of Mammalian Cell Line Development for Monoclonal Antibody Production
Abstract not available at time of print. Jianguo Yang, Ph.D., Scientist and Group Leader, Cell Line Development, MedImmune LLC / Biologic Unit of AstraZeneca PLC
3:40
Networking Refreshment Break in Exhibit & Poster Hall
Technical Session II:Analytical Characterization and Quality ControlSession Chair: Julius Zhiliang Li, MSc., MBA, Chief Executive Officer, AutekBio, Inc.
2:00
Analytical Characterization of Novel Antibodies & Proteins
Quality control is the foundation of all protein-based medicines, and comprehensive protein characterization is the keystone of quality control. The factors which can impact protein properties and possibly, quality can be assessed with specific analytical methods. A few case studies will be discussed to illustrate how the methods can enhance in-depth understanding of protein structures, therefore leading to better quality control of protein-based medicines. Yang Wang, Ph.D., Associate Director, Bioprocess Analytical and Formulation Sciences, Merck & Co., Inc.
2:25
Biologics Characterization and Comparability Assessment
Abstract not available at time of print. Mark Moody, Senior Director, Quality Control and Formulation, Merrimack Pharmaceuticals
2:50
Physico-Chemical Comparability of Biosimilars
There is much interest in analytical methods for demonstrating comparability of biosimilars to the reference product. The process of development under the biosimilar regulatory pathway includes in-depth characterization of the originator product to define the development target, continuous comparison of the new version of the biopharmaceutical and the existing reference version by extensive physicochemical analysis and a final comparability exercise for confirmation of achieved similarity. Results of the comparative analysis show comparability are required for predicting therapeutic equivalence. Zheru Zhang, Ph.D., Director, Analytical Development, Celltrion Technology Workshop
3:15
Technology Workshop - Available for Sponsorship
IBC's technology workshops offer suppliers and service companies the opportunity to present their exciting technologies in drug discovery and development to a targeted and captive audience during the conference sessions. For more information on this unique opportunity, please contact Chris Leger or Wendy Wong
3:40
Networking Refreshment Break in Exhibit & Poster Hall
Technical Session III:Cell Culture & Media DevelopmentSession Chair: David (Xiaojian) Zhao, Ph.D., Technical Area Manager, Research & Development, Life Technologies
4:15
Development of A Platform Chemically-Defined Basal Medium For CHO Cell Culture Process
In recent years considerable effort has been directed to the development and implementation of chemically defined media for industrial cell culture processes. Here we describe an approach in developing chemically defined basal medium for platform CHO cell culture processes. Development strategies like model cell line selection and performance evaluation criteria (growth, titer, metabolism etc) will be discussed, with attention also on balancing platform vs specific cell line performance. Improvements in media stability will also be discussed. The platform basal medium supports majority cell lines for over 1.0 g/L titer in batch cultures, and coupled with suitable feeding strategies can yield significantly higher titers across multiple cell lines. Jincai Li, Ph.D., Senior Engineer, Oceanside Process Research & Development, Genentech, Inc.
4:40
Novel Cell Culture Media and Process Development
Developing fed-batch media platforms with chemically defined basal medium and feed for bioproduction cell lines is traditionally a difficult and time consuming process. We have used integrated systems with HT instruments and data handling for rapid media and process development. Deliberate design of an integrated basal medium, feed medium, and feed strategy in fed-batch is also adapted. David (Xiaojian) Zhao, Ph.D., Technical Area Manager, Research & Development, Life Technologies
5:05
Humanization of Anti-C2 Antibody and the Fast Selection of High-Antibody Producing Clones Using an Automated System
Murine anti-C2 antibody recognized epitopes expressed in ior C2 antigen, a glycoprotein complex expressed in human malignant colorectal cells. The anti-C2 antibody was humanized using a novel method developed and licensed from Center of Molecular Immunology, Cuba. An automated system was used for rapid selection of the high-producing clones. Zulkeflie Zamrod, Ph.D., Vice President, R&D, Protein Science, InnoBioVentures Sdn Bhd. Technical Session IV:Analytical Methods DevelopmentSession Chair: Julius Zhiliang Li, MSc., MBA., Chief Executive Officer, AutekBio, Inc.
4:15
Chromatography as an Indispensable Tool for the Characterization of Protein Biopharmaceuticals
Key quality characteristics of recombinant proteins that need to be elucidated and controlled during process and product development include product-related variants with modifications in the amino acid chain, glycan heterogeneity and the correct and uniform formation of disulfide bridges. Chromatography hyphenated with mass spectrometry is an indispensable tool for the analytical characterization of these variants. Case studies from various development projects will be presented. Hansjoerg Toll, Ph.D., Laboratory Head, Sandoz GmbH
4:40
Analytical Validation of a Carbohydrate Profiling Method for a Monoclonal Antibody by Capillary Electrophoresis
Due to the complexities of carbohydrate profiling methods and capillary electrophoresis, there exists significant challenges in executing a comprehensive analytical validation study. This presentation focuses on practical considerations for the design of relevant validation parameters, selection of appropriate acceptance criteria, interpretation of the validation data, and general regulatory perspectives. Michael Byrne, Ph.D., Director, Analytical Sciences, Human Genome Sciences
5:05
Use of Design of Experimentation (DOE) In the Development and Validation of a Potency Assay for Live Attenuated Flu Vaccines
The Design of Experimentation (DOE) tool has been used in the optimization and validation of manufacturing processes and analytical methods. Historically the use of DOE in manufacturing has resulted in significant reduction in the development time and in the cost of production and thus yielding a significant savings to an organization. A case study will be presented on the use of DOE in development and validation of a potency assay for live attenuated Flumist®. Kuldip Sra, Ph.D., Principal Scientist, VAS, MedImmune LLC
5:30
Cocktail Reception in Exhibit & Poster Hall
Monday | Tuesday Main Conference - Plenary SessionThe Business and Regulatory Guidelines for Biosimilars/Follow-on Biologics
8:00
Registration and Coffee
8:50
Chairperson's Opening Remarks
Chris Z. Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals
9:00
Business of Biosimilars in the USInsmed is a biotechnology company focused on therapeutic protein drug development. In 2007, Insmed initiated the development of a Follow on Biologics platform and successfully sold that business unit to Merck in 2009. This talk will focus on the business, regulatory and legislative climate in the US and overview the critical components required to build a successful follow on biologics business. Geoffrey Allan, Ph.D., President & CEO, Insmed Incorporated
9:30
Challenges of Developing Biosimilars In China: A Case Study on Generic Etanercept
An established pathway for biosimilars in Europe/Canada and pending pathway in the US attract much attention of biotechnology companies in China. Although there are many players in the field of biopharmaceuticals, Chinese companies face many challenges of developing biosimilars for the US/EU market. In this talk, generic etanercept developed by Shanghai Celgen will be used as a case study to demonstrate how Shanghai Celgen overcomes these challenges and develops a high-quality generic etanercept. Chris Z. Chen, Ph.D., Chief Operating Officer, Shanghai Celgen Biopharmaceuticals
10:00
Biosimilars/Follow-on Biologics: Overview of Scientific/Regulatory Guidelines and Experience
The concept of comparability has been expanded significantly to also provide the scientific basis and framework to provide documentation that a biosimilar/follow-on protein is comparable to an identified reference product by the inclusion of appropriate non-clinical and clinical studies as currently implemented in EU and discussed in other regions. This talk will provide an overview the regulatory experience with biosimilar submissions till now, both approvals and rejections, and also discuss these in the context of innovator post-approval changes. Inger Mollerup, Ph.D., Vice President, Regulatory Affairs, Novo Nordisk A/S
10:30
Recent Bills in the US on Biosimilars and the Outlook In View of the Hatch-Waxman Act
The push is strong in the US for a biologics version of the Hatch-Waxman Act which has been a success in lowering the drug prices by allowing earlier entry of generics while still giving innovators sufficient incentives. What can we expect from the recent bills in the US on biosimilars? And what opportunities may a law provide in view of the Hatch-Waxman Act? Weisun Rao, Ph.D., J.D., Principal, Miller, Canfield, Paddock and Stone P.L.C.
11:00
Networking Refreshment Break in Exhibit & Poster Hall
Process Development & Manufacturing Technology
11:30
Effective Process Development and Manufacturing Technology for Biologics Manufacturing – An Overview
Abstract not available at time of print. Steven Lee, Ph.D., Chief Executive Officer, A-BIO
11:55
Outlook of Manufacturing Technologies and Impact on Chinese Biopharmaceutical Industry
The latest development in manufacturing technologies is joining other driving forces to reshape the landscape of global biopharmaceutical industry. The innovations will create new platforms for bioprocessing, offering competitive advantages and tremendous opportunities to current biomanufacturers. With some proven successes, it will help enable niche products and bring emergent players to Chinese market. Ran Zheng, Ph.D., Executive Director, Plant Manager, Clinical Operations, Amgen Inc.
12:20
Emerging Biopharmaceutical Outsourcing Opportunity in Asia
This talk will provide the audience with an overview of the basic principles in engaging CMOs, and an understanding of certain pitfalls in process and technology transfer from a technical perspective. Some of the well established CMOs in Asia will be introduced, and relevant cases of global outsourcing experience will be shared in the presentation. Frank Ho, Ph.D., Senior Manager, Clinical Manufacturing, BioMarin Pharmaceutical Inc.
12:45
Networking Luncheon and Last Chance to Visit Exhibits & Posters
Main Conference - Concurrent SessionsTechnical Session V:Purification and RecoverySession Chair: Joe Zhou, Ph.D., CEO, ShineRun BioPharma Co., Ltd., Biopharmaceutical Division of Wison Group
2:00
Overcoming Current Challenges of High Titer Cell Cuture for Future mAb Manufacturing Production
In this presentation, the challenges from high titer cell culture are reviewed based on the concerns of product quality and bottleneck. To further reduce the manufacturing cost, the feasible solutions proposed include:
2:25
Multiple Options for Aggregate Removal by Apatite Chromatography
Apatite chromatography has emerged as one of the most effective methods for removal of aggregates from purified monoclonal IgG preparations. Due to variations from one monoclonal to another, and because of the multimodal interactions of antibodies with apatites, it is impossible to predict what conditions may be required to achieve the best aggregate removal. This presentation will discuss the dominant interactions between IgG and apatites, and provide a series of method development templates that allow rapid identification of the most effective conditions for aggregate removal. Pete Gagnon, Ph.D., Chief Scientific Officer, Validated Systems
2:50
Flexible Manufacturing, a New Driver for Economics of Biopharma Production
3:15
Evaluation of the Economical and Regulatory Impact of Sequential Multi-Column Chromatography in Downstream Processing
Continuous purification processes are well established in petrol, food and small molecule API's applications where cost of goods is critical. Technology principles and process know-how have been successfully extrapolated from these industries to create powerful new tools for the downstream processing of biopharmaceuticals and help to "De-Bottleneck". One example is Sequential Multi-Column Chromatography (SMCC), a semi-continuous purification technology, which can significantly increase purification productivity and reduce drastically buffer consumption and cost of goods compared to traditional approaches. This technology also offers the possibility to streamline biopharmaceutical-manufacturing processes. A detailed explanation of SMCC will be given along with evaluation of the impact on cost of goods and process validation based on case studies (capture of MAbs). Laurent Rebier, Pharma Market Expert-Asia, NOVASEP Asia
3:40
Networking Refreshment Break
Technical Session VI:Manufacturing Infrastructure & Technology TransferSession Chair: Scott Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc.
2:00
Process Considerations in the Manufacture of a High Concentration Protein Drug Product
Key process parameters such as processing temperature, time and product viscosity impact the drug product production of a high concentration mAb formulation. Formulation changes in conjunction with adjustments of temperature and viscosity ease the UF/DF step, mixing and filling, thereby minimize protein loss in flush and increase the overall yield. Jeremy Guo, Ph.D., Senior Scientist, Genentech
2:25
Modern Design of Multi Product Vaccine Facilities
The trend within design of Biotech facilities moves very fast towards Multi Product facilities. This presentation will cover a number of potential design drivers and look into the benefits as well as the challenges. Disposable technology (Single Use) is one of the tools for successful Multi product design and there will be a strong focus on this technology. Finally, a number of actual cases will be presented in order to support the design strategy. Klaus Hermansen, Ph.D., Senior Specialist, Management Consulting, NNE Pharmaplan
2:50
Technology Transfer and Manufacturing of a Soluble Recombinant Protein – A Case Study
Technology transfer and manufacturing of a recombinant protein in E. coli was carried out twice, at different stages of development and with different CMOs. From severe time constraints and unfamiliar process complexity to significant facility and operational limitations, the two campaigns provided contrasting lessons and experiences. Sa V. Ho, Ph.D., Senior Research Fellow, Pfizer Inc.
3:15
Case Study In Improving Regulatory Compliance While Reducing Costs
Many in the industry believe that cost reduction jeopardizes compliance or that improving regulatory compliance always costs money. This presentation includes cases where costs were reduced and compliance improved. A methodology is presented with financial results and data regarding how compliance was improved. Chris S. Driscoll, Principal, Life Sciences, Tunnell Consulting
3:40
Networking Refreshment Break
Technical Session VII:Protein FormulationSession Chair: Wei Wang, Ph.D., Associate Research Fellow, Global Biologics, Pfizer Inc.
4:15
Multiple Roles of Surfactants in Protein Formulation
Surfactants are an important class of formulation excipients. This presentation discusses the multiple roles of surfactants in controlling protein stability and aggregation. Examples demonstrate that careful selection of non-ionic surfactants in stability evaluation is critical in the development of successful protein products. Wei Wang, Ph.D., Associate Research Fellow, Global Biologics, Pfizer Inc.
4:40
Lyophilization Process Development, Scale Up and Validation for Protein Drug
The recombinant Factor VIII (rFVIII) with a trade name Kogenate-FS, made by Bayer HealthCare, is the largest protein genetically engineered by biotech industry. Due to the complexity and instable of the protein, there are many difficulties and challenges to the lyophilization process. This presentation provides a review of how we characterize the formulation, develop the lyophilization cycle, and then scale-up and validate the process. D.Q. Wang, Ph.D., Dept. Head of Formulation, Freeze-drying and Drug Delivery, Global Biological Development, Bayer HealthCare
5:05
Effect of Pegylation on Protein Aggregation During Formulation Development and Its Implication for Developing Me-Better Protein Therapeutics
In this presentation, the issues related to protein aggregation during formulation development shall be discussed. The modulation of protein aggregation by pegylation will be elucidated and the application of pegylation to the development of me-better protein therapeutics will also be discussed. Tiansheng Li, Ph.D., President, HTL Biosolutions, Inc.
5:30
Close of Conference
Technical Session VIII:Single Use/DisposablesSession Chair: Scott Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc.
Session Sponsored by
4:15
Technical and Economic Considerations Regarding Design and Application of Single-Use Systems
Even though some Asia Pacific countries have lower labor costs, a thorough understanding of gaps between perceptions and reality is required. Various examples have demonstrated that single-use systems can offer 40-50% reduction in implementation time, 45-55% decrease in capital investment costs, and about 60% reduction in annual costs. Incremental production due to reduction in downtime cross contamination risks can also be gained. This workshop will provide information on the aforementioned topics including the application of single-use systems compared to traditional stainless steel systems; environmental considerations; and product contact surface issues (e.g., leachables and extractables considerations). Surendra Balekai, Technical Services Manager, Thermo Fisher Scientific
4:45
Process Development and Scaling-up Using Disposable Technologies, The New Frontier of Manufacturing Biologics
Advanced technologies in mammalian cell line and process development have made the possibility of biologics production at yields as high as 20 g/L a reality. Even though these processes are still at small to pilot scales and limited to few biologics such as recombinant antibody productions, with the combination of using single use technologies and further improvement in scaling-up processes it may bring revolution to the manufacture of biologics. Large scale upstream processes without using traditional stainless steel bioreactors may become an option for fast and cost effective biologics manufacturing. What does it mean in future plant design and what new hurdles we will have to solve? Topics in this area will be discussed. Lei Sun, Ph.D., President, Manufacture, AutekBio (Beijing) Inc.
5:15
Close of Conference
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