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BioProcess International™ China
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Agenda
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Tuesday | Wednesday
8:00
Registration and Coffee
8:50
Chairman's Opening Remarks
Scott Liu, President and CEO, Shanghai Henlius Biotech, China Keynote Presentations
9:00
Large Molecules Present Great Opportunities in China"Availability and affordability" shall be the focus of China's life science industry for future years. Few biologics drugs are currently available in China, despite the increasing demand from Chinese patients for more disease-modifying biologics as novel treatments. Making biologics available and affordable drives WuXi to heavily invest to build a world-class integrated discovery, development and manufacturing platform for biologics in China. WuXi's open-access biologics platform allows companies of any size to tap into WuXi for biologics product development at any stage and renders WuXi to be the gateway for novel biologics development in China. Ge Li, Ph.D., Chairman & CEO, WuXi AppTec, China
9:30
Manage Supply Risk by Building a Robust Biomanufacturing NetworkScientific breakthroughs in biotechnology have changed the practice of medicine. Growing demand in unmet medical needs and technology advancement has resulted in significantly increased biomanufacturing scale and complexity in recent decades. Manufacturing a biologic requires multiple scientific disciplines. Sophisticated, science-based controls are essential to ensure safe and effective products. This presentation will discuss the strategies to prevent interruption in the complex process of manufacturing and reliably supply of biologics medicines to patients. Jian Irish, Ph.D., Executive Director, Asia Region General Manager, Manufacturing and Supply Chain, Amgen, Inc., USA
10:00
Networking Refreshment Break and Opening of Exhibit & Poster Hall
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Cell Line Engineering, Cell Culture and Media Development
10:40
Chairman's Remarks
TBA
10:45
Cell Line Development Improvements at Genentech to Avoid Potential Comparability Challenges and Enable Accelerating Biopharmaceutical Development
We have previously used a 2-cycle cell line development (CLD) approach (one line for early clinical production and a different line for late clinical and commercial production) to enable rapid entry into initial clinical studies. With the advance of new technologies, we have developed and implemented a 1-cycle CLD platform process that uses the same cell line from Tox all the way through commercial production, yet still allows fast entry into the clinic. This avoids potential comparability challenges associated with cell line changes and provides an opportunity to move from Phase I to Phase III quickly, if needed, for accelerating programs. This presentation will articulate cell line development strategies, throughputs, challenges, and benefits of past and current CLD processes. Amy Shen, Senior Scientist, Early Stage Cell Culture, Genentech, Inc., A Member of the Roche Group, USA
11:15
No Need to Sacrifice Titer or Quality: An Integrated Approach for Process Development
Protein titer and final product quality can be a trade-off, whereby titer is sacrificed in order to get desirable quality profiles. By integrating products used during process development, high productivity yields of protein products with desired quality attributes can be achieved. The integration of these products and design approach is also key to shortening timelines and removing bottlenecks. Zhihua Xiao, Ph.D., Process Science Fellow, Life Technologies, USA New, Unpublished Data
11:45
Case
Balancing Quantity with Quality: Finding a Sweet Spot in Antibody ProductionStudy Protein expression technologies have evolved such that titers of multiple grams per liter are routinely achieved for "well-behaved" antibodies. However, titer increase is frequently accompanied with increase of aggregates and decrease of glycosylation and sialylation in antibody and fusion protein production. This presentation will discuss process parameters that affect these critical quality attributes with case studies and strategies to increase the product yield while maintaining the product quality. Minmin Qin, Ph.D., Chief Technology Officer and Senior Vice President, Shanghai JMT-Bio, Inc., China
12:15
Networking Luncheon with Exhibit and Poster Viewing
1:30
Case
Biologic Development Program at Luye Pharma GroupStudy This presentation provides an overview of Luye Pharma Group and its biologic development strategy and capabilities. A case study on cell culture process development for one of Luye's biosimilar projects will be presented. Changlin Dou, Ph.D., Chief Technology Officer, Biologic R&D, Luye Pharma Group Ltd., China
2:00
Integrating Custom Mammalian Cell Culture Designs with Single-Use Platforms
To achieve optimal performance from cell culture systems, many biotech companies look to customize cell culture media and supplements, and then apply them in traditional production systems. While this can be effective, recent studies have shown that to achieve peak performance, consideration for not only the nutrients, but also the design of the bioreactor is critical. Described herein will be examples where the integration of media and supplement design with single-use systems through various analytical technologies have demonstrated notable increases in overall process performance and efficiency. Justin D. Hutchinson, Associate Director, Product Management, Thermo Scientific Cell Culture & Bioprocessing, USA
2:30
Media Enhancement Methods for Biologics Production
Media development strategies provide opportunities for performance differentiation within biopharmaceutical firms, with speed, productivity, consistency, and cost-effectiveness of upstream processes as major goals. Kerry has advanced media supplement solutions and services that target synergies among popular basal media (BM), CDM, SFM, to address the evolving needs of our customers, across a variety of industrially important cell lines and media design priorities. Speaker TBA, Kerry |
Analytical Characterization, Comparability and Quality
10:40
Chairman's Remarks
Jennifer Wang, Ph.D., Scientist and Group Leader, Protein Analytical Chemistry, Genentech, Inc., A Member of the Roche Group, USA
10:45
Regulatory and Scientific Perspective on Product Comparability Evaluation
To support the analytical assessment of comparability and increase the likelihood of maintaining a comparable product, it is key to understand the impact on efficacy and safety of critical product quality attributes (PQA) at early stage of product development, so proper in-process controls can be put in place during process changes to limit or avoid any impact on PQAs. In this presentation, an innovative way to evaluate PQA in vitro at an early stage of the process development will be discussed. This approach may be used to predict the dynamic changes of PQA before any animal or clinical study is done. An example using an Fc fusion protein and an IgG2 antibody will be discussed. Grace Jiang, Ph.D., Senior Manager, International Regulatory, Amgen, Inc., USA
11:15
Improved Platform Analytical Methods for mAb Control Systems
Leveraging biochemical similarities of monoclonal antibodies (mAbs), we developed and improved platform analytical methods, including ion exchange chromatography, to support bioprocess development, product characterization and control system testing. Introducing platform methods during early development significantly reduces time and expenses, and ensures consistency across different labs. Carrying the same platforms throughout the product life cycle will not only increase efficiency but also compliance. Improved platform analytical methods for mAb control system testing will be presented. Jennifer Wang, Ph.D., Scientist and Group Leader, Protein Analytical Chemistry, Genentech, Inc., A Member of the Roche Group, USA
11:45
Small Scale, High-throughput Purification and Characterization Platforms for Better Decisions via DOE
LabChip microfluidic technology enables multiple protein critical quality attributes — titer, purity, glycosylation, aggregation, glycan profiling and charge variants, by providing comparable resolution and sensitivity at 60X speed and greater ease of use with a highly reproducible manner. The new JANUS® Biotx Pro workstation on the other hand provides scientists with automated small-scale purification using a choice of batch binding in filter plates, tip-based chromatography, and robotic-controlled mini-columns to enable "click-and-go" sample preparation. Combined with high throughput expression technology, now it is possible to define all kinds of variables that could affect the productivity or quality of the biotherapeutics in shorter development cycles and increased efficiency, and therefore accelerate both cell line optimization and process development. Katherine Hu, Product Line/Marketing Manager, Perkin Elmer, China
12:15
Networking Luncheon with Exhibit and Poster Viewing
1:30
Using ambr to Bring Biologics to Market Faster, with Increased Profit. New Data, New Applications
Once a large molecule has been established as relevant for an indication, teams managing cell line selection and process development face diverse challenges that must be overcome in order to scale up to the levels needed for clinical assessment and, ultimately, commercial manufacturing. These challenges include: how to explore sufficient cell lines to identify clones with optimal protein expression; how to perform Design of Experiment (DoE) analyses with suitable power to rapidly identify relevant culture parameters; how to explore more cell line candidates and culture conditions to enable better, faster decision making and; how to accelerate cell line selection and process development activities overall, to reach the clinical phase faster. Current approaches are limited by infrastructure that requires significant labor input, laboratory space and capital investment. In addition, certain techniques may not consistently predict culture behaviour at larger scale. TAP Biosystems' advanced microbioreactor (ambr™) technology has been widely adopted as an effective solution to such problems. In this session we present an overview of the technology, plus industry derived data that demonstrate ambr's suitability for cell culture optimization, in the context of biotherapeutics development. In this update, new data will be presented and novel applications for ambr will be described. Ian Ransome, Director, Asia Pacific, TAP Biosystems, United Kingdom
2:00
Case
Characterization and Comparability Assessment of Product Quality Attribute Differences in Protein Therapeutics Before and After Process ChangeStudy Manufacturing process change often impacts product quality attributes. To demonstrate the product comparability upon process change, product needs to be fully characterized and any difference needs to be assessed for its potential impact to safety, efficacy, and immunogenicity. This talk will include two case studies with different comparability decisions based on the observed differences between products produced from different processes. Connie Lu, Ph.D., Senior Scientist, Global Method Management and Technology, Genentech, Inc., USA
2:30
Case
Adjustment of Critical Quality Attribute (CQA) by Multivariate Analysis (MVA) in Biosimilar Media Supplement DevelopmentStudy Quality by Design (QbD) is the approach towards development and commercialization of biologics. In QbD, the process is designed and controlled to deliver critical quality attributes (CQA) consistently. Such process controls are particularly important for biosimilar development since they are required to demonstrate CQA similarity to reference drugs. We present a case study here that we applied multivariate analysis (MVA) to adjust the CQA of a biosimilar drug. CQA of a biosimilar product was adjusted to the reference drug criteria by cell culture media supplement optimization using MVA. Moreover, such optimization resulted in a more robust biomanufacturing process. H. Fai Poon, Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China |
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3:00
Networking Refreshment Break with Exhibit and Poster Viewing
Panel Discussions
3:45
The Commercial Landscape and Business Considerations for Developing Biosimilars in China
Ming Wang, Ph.D., President and Chief Operating Officer, Gan & Lee Pharmaceuticals Ltd, China Panelists: Scott Liu, President and CEO, Shanghai Henlius Biotech, China Hai Pan, Ph.D., Vice President, Research and Development, Beijing Kawin Technology Share-holding Co., China
4:30
Strategies for Developing Biologics Partnerships in China: How to Find the Right Partner with the Right Capabilities to Accelerate Market Launch of Your Products
Yariv Hefez, Vice President, Head Business Development, Alliance Management Biosimilars, Merck Serono SA, Switzerland Panelists: Joe Zhou, Ph.D., Chief Executive Officer, Genor BioPharma, Wison Group; Visiting Professor, Peking University, China Greg B. Scott, President and Founder, ChinaBio LLC, China Allan Riting Liu, M.D., Ph.D., Vice President/Senior Advisor, Wanbang Biopharmaceutical Group/Fosun Pharma, China
5:15
Networking Cocktail Reception with Exhibit and Poster Viewing
Tuesday | Wednesday
8:40
Chairman's Opening Remarks
Scott M. Wheelwright, Ph.D., Founder and Principal Consultant, Complya Asia Co., Ltd., China Keynote Presentation
8:45
Anti-Cancer Antibody Development in ChinaAbstract not available at time of print. Yajun Guo, M.D., Ph.D., Professor and Director, Shanghai International Joint Cancer Institute, Shanghai Second Military Medical University, China Featured Presentation
9:15
Development of the World's First mAb Biosimilar, RemsimaTM, at CelltrionCelltrion successfully developed the world's first Infliximab Biosimilar, RemsimaTM, which received approval from the Korean FDA in 2012, and it is currently under review by European regulatory authorities. Furthermore, 2 biosimilars are currently under Clinical Trials while 1 new product has completed Non-Clinical Trial and is in preparation for Clinical Trials. Celltrion's general strategy in mAb biosimilar development and CMC, Non-clinical and Clinical data for RemsimaTM will be presented. ShinJae Chang, Ph.D., Vice President, R&D, Celltrion, South Korea Strategies for Accelerated IND Filings in China
9:45
Case
Practical Quality and Comparability Considerations during Development of Biosimilar/Biobetter Antibody Therapeutics in ChinaStudy To achieve a successful IND filing with SFDA, antibody therapeutic products' quality, safety, efficacy and comparability must be evaluated and demonstrated. This presentation will use real case studies to show some practical considerations we have implemented to achieve analytical GMP compliance in order to ensure a successful regulatory filing. Boyan Zhang, Ph.D., Chief Scientific Officer & Executive Vice President, Beijing Mab-works, Inc., China
10:15
Networking Refreshment Break with Exhibit and Poster Viewing
New, Unpublished Data
10:45
Case
Coordinating Bioprocess/Analytical Development, QC, and Preclinical Studies for IND Filing of a Novel MoAb in 1.5 years - Lessons LearnedStudy Rapid development of the biological drug industry in China calls for efficient technology transfer, talent team building, and professional coordination of upstream/downstream process development, analytical development, quality control, preclinical efficacy/safety evaluation, and IND filing. SFDA has very stringent requirements for antibody drug IND. This presentation will discuss some key aspects on how to streamline early stage development of high quality monoclonal antibody drugs in China. Yucai Peng, Ph.D., Vice President of Research and Technical Development, Livzon MabPharm, Inc., China Panel Discussion
11:15
Biologics Regulation, Clinical Trials, Facilities and Technologies for Biotherapeutics in US/Euro Compared to China: Similarities and Difference - What Can We Learn from Each Other?
Klaus Hermansen, Senior Technology Partner, Vaccines, NNE Pharmaplan, Denmark Jack Ping Chen, Manager, NNE Pharmaplan, China Panelists: Joe Zhou, Ph.D., Chief Executive Officer, Genor BioPharma, Wison Group; Visiting Professor, Peking University, China Grace Jiang, Ph.D., Senior Manager, International Regulatory, Amgen, Inc., USA Scott Liu, President and CEO, Shanghai Henlius Biotech, China China SFDA , CDE, CQAP (Invited)
12:15
Networking Luncheon with Exhibit and Poster Viewing
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Biomanufacturing, Facilities and GMP Compliance
1:40
Chairman's Remarks
H. Fai Poon, Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China
1:45
Establishing Biomanufacturing Capacity in China
This presentation discusses strategies for managing the facility delivery life-cycle - from process development to operation. Innovative facility delivery models are presented including standardized facilities equipped with single-use technology. John Machulski, Enterprise Solutions, GE Healthcare Life Sciences, USA
2:15
Implementing Seamless Transfer of Control Solutions from Lab-scale R&D to Large-scale Manufacturing
This presentation introduces universal controllers for greater efficiency in biomanufacturing processes. It describes the implementation of smart components with scalability to allow for more distributed control of processes. Innovative single-use bioreactor options from small to large scale to accommodate R&D and large scale manufacturing processes are also discussed. Barbara Paldus, Ph.D., Chief Executive Officer, Finesse Solutions, USA
2:45
Issues in cGMP Compliance in Asia
The manufacture of biologics and other pharmaceutical products requires compliance with exacting standards for current Good Manufacturing Practice (cGMP). These standards are set by international regulatory bodies such as the European EMA, the US FDA, China's SFDA and the World Health Organization. Failure to comply with these regulations can result in substandard product performance, injury to patients, and failure in the marketplace. Regulatory authorities routinely inspect manufacturing facilities throughout the world to ensure compliance with cGMP standards and regulations. In this presentation we will review several recent failures of companies to comply with the regulations. Study of such failures can assist us in preparing our own facilities for inspection and avoiding the failures of others. Scott M. Wheelwright, Ph.D., Founder and Principal Consultant, Complya Asia Co., Ltd., China
3:15
Networking Refreshment Break with Exhibit and Poster Viewing
3:45
Case
Biosimilars: Challenges and SolutionsStudy Manufacturability is a critical issue, particularly for biosimilars. Manufacturing issues, particularly the CMC-related (Chemistry, Manufacturing and Controls) cost more product rejections and/or delays than any other factors in developing therapeutic proteins. Unfortunately, developing a good process is often compromised for "rushing to the clinic", which costs more delays down the road. Due to the lack of expertise in process development, biotech companies in countries like China require significant investment in PD to avoid costly mistakes. In this presentation, in addition to the general issues facing the therapeutic protein developers, current technologies in manufacturing therapeutic proteins will be reviewed. Case studies will be presented to illustrate the importance of robust and consistent manufacturing processes in the successful development of biological products. Jeffrey Su, Ph.D., Chief Scientific Officer and Chief Development Officer, Cytovance Biologics, Inc., China
4:15
Develop and Produce High Quality mAb Based Biopharmaceuticals
China's Biopharmaceutical industry is poised for a big leap. The market is thirsty for much needed prestigious biopharmaceuticals especially mAb products. However, there are challenges to product high quality mAbs due to the lack of experiences for process development, scale up and cGMP commercial manufacturing as well as the sub-optimal infrastructures (international standard cGMP facilities). These challenges have been recognized by Central Government especially CFDA (previous SFDA). CFDA have committed to tighten up the regulation to raise the quality standard. In this talk, author is going to discuss the current landscape of Chinese Biopharmaceutical industry and opportunities. Youling Wu, CEO, ZheJiang Teruisis Pharmaceutical Inc., China
4:45
The Role of Quality Management in R&D and Manufacturing of New Biologics in China
China's pharmaceutical market is the third largest in the world now and its growth accounts for about 20% of the industry's global growth annually. New biological products attract more longterm investments than other sections of China's pharmaceutical industry today. The Chinese pharmaceutical companies and regulatory agency used to emphasize quality management mainly in the manufacturing of pharmaceutical products, most of which are traditional Chinese medicine and "follow-on" products of small molecules that have been approved elsewhere, mostly overseas. Unlike traditional Chinese medicine and small molecules, biologics generally exhibit much higher molecular complexity and sensitivity to changes in process, which often makes it more difficult to bring new biologics from the lab to the market. Companies and regulatory agency in China have started to rely on quality management during the R&D stage of new biologics for a better chance of success. Wang Yongzhong, Ph.D., Special Assistant to the President, Kanghong Pharmaceutical Group Co., Ltd; Deputy General Manager, Chengdu Kanghong Biotechnology Co., Ltd., China
5:15
Close of Conference
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Downstream Processing and Purification
1:40
Chairman's Remarks
Richard Nian, Ph.D., Scientist, Downstream Processing Group, Bioprocessing Technology Institute, Singapore Featured Presentation
1:45
Broad Basis HTS for the Right Solution in Downstream ProcessingIn DSP, scientists have to think from the beginning and screen a broad range of resins for each single purification step in HTS, from 96 well plate format mini columns to selected resins in 10 mL prepacked columns. The evolution of new resins has to be considered as part of the screening. Process validation and virus validation studies, to be most time efficient, should be performed in standardized pre-packed single-use columns, because the consistent column device allows direct comparison of different resins. Such a broad-based development strategy gives confidence that the optimal process parameters have been selected. Rolf G. Werner, Professor, Industrial Biotechnology, University of Tuebingen, Germany
2:15
High Capacity and Salt Tolerant Ion Exchange Resins for Polish Chromatography
The unique features and performance of POROS® cation exchange and anion exchange chromatography resins for the removal of common process impurities in downstream purification will be discussed. The benefits of high capacity, high resolution, and salt tolerant resins, as they relate to improving downstream purification process performance and productivity, will be proposed. Applications data centered on aggregate and leached recombinant protein A removal will be used to demonstrate the benefits of POROS® to downstream processing. Christine Gebski, Head Chromatography Business and Global Applications, Life Technologies, USA
2:45
New Purification Technology for Purification of Lower-Cost Higher-Quality Biosimilar Antibodies
This presentation will highlight advances in purification of monoclonal antibodies that support major reductions in cost, combined with major improvements in quality. One of the new purification methods introduced is steric exclusion chromatography (SXC), which employs inexpensive single-use particles in a fluidized tangential flow format. Capacity exceeds 200 mg/mL and it reduces host protein to less than 200 ppm post-capture. The no-column format supports processing of any volume of superantant in a single cycle. The presentation will also describe a new mode of conducting anion exchange chromatography called void exclusion. When used as the intial fractionation step, it reduces host protein contamination to less than 100 ppm, while reducing DNA and virus by 3.5 logs or more. Results from fully integrated 2-step processes will be presented with a Trastuzumab biosimilar that achieve less than 1 ppm host contamination, less than 0.01% aggregate, and 90% IgG recovery. Richard Nian, Ph.D., Scientist, Downstream Processing Group, Bioprocessing Technology Institute, Singapore
3:15
Networking Refreshment Break with Exhibit and Poster Viewing
Viral Safety Strategies for Biologics
3:45
The Smart Way to Optimize Virus Filtration Steps
Current biomanufacturing processes have reached a high degree of standardization and companies are working on the basis of proven technology platforms. While this helps to set up new purification trains in short timeframes, virus clearance concepts still require a thorough optimization to address economic challenges and product related characteristics. The tool box is getting bigger with different membrane types and features, different pre - filtration methods as well as product conditioning. This presentation focuses on different ways to optimize virus filtration to end up with the most efficient steps. Anika Meyer, Product Manager, Virus Clearance, Sartorius Stedim Biotech GmbH, Germany
4:15
Virus Removal from Biotherapeutic Products
Our state of the art Hollow Fiber technology provides robust viral removal by size exclusion and offers high recovery rate of target protein. The Planova BioEX filter with hydrophilized polyvinylidene fluoride (PVDF) hollow fibers are developed as a result of the demands from the biopharmaceutical industry. Speaker TBA, Asahi Kasei
4:45
Producing Quality Biologics in China: Practical Solutions to Reduce Potential Viral and Other Microbial Risks
Several practical approaches to significantly reduce the risk of potential virus or other microbial contaminants in biologic products have been developing for many stages in the manufacturing process. Approaches to reducing virus risks at several levels will be discussed to increase viral barriers and improve testing at the raw material and cell line stages, as well as the process development & viral vlearance stages. We will also present on recent additional process and biosafety service additions that WuXi AppTec is adding for biologic products made for the Asian market. Joseph Hughes, Ph.D., Chief Scientist, Virology and Vice President, WuXi AppTec, Inc., USA
5:15
Close of Conference
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