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Tuesday, September 21, 2010 (continued) • Main Conference Managing Manufacturing Networks 10:45 New, Unpublished Data CASE STUDY The Dinosaurs Reborn: Retrofitting Existing Facilities to Speed Tech Transfer and Support the Platform Process We discuss the current bifurcation of biomanufacturing capacity into small volume manufacturing plants, (dominated by single use technologies) and large volume plants (that are still stainless steel). Such a bifurcation is likely to continue, with large facilities becoming increasingly important drivers of revenue - provided they can be transformed into more agile manufacturing plants. We suggest technologies that support this effort focusing around changeovers, tech transfer and platform process design. Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley 11:15 How Process Simulation is used in Biogen Idec to Optimize Manufacturing Processes Biogen Idec is continually investigating the impact of new technologies on their operations. This includes using process simulation to determine process fits of new products into existing facilities. Here we present several case studies including the impact of employing high titer processes. We investigate the potential bottlenecks, determine equipment changes/upgrades that are required, and the effect this has on the overall costs of goods, and required investment. Ian Gosling, Ph.D., Principal, ChemSim LLC Product Lifecycle Management 10:45 What do you Need to Do to Fully Leverage Flexibility Inherent in QbD The overarching initiative of the FDA remains the “Drug Product Quality.” It embraces many initiatives, one of which is Quality by Design (QbD). QbD is not a new concept. It has recently however, been formally introduced to our industry, in particular in terms of regulatory processes. Unless and until the regulatory, science, engineering and control issues are addressed then the desired regulatory flexibility will not be realized. This presentation will address possible means of gaining flexibility within the QbD framework. Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; former Senior Staff Fellow, OPS, CDER, US FDA 11:15 Audience Interactive Panel Discussion Leveraging Flexibility in QbD Moderator: Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. Panelists: Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; former Senior Staff Fellow, OPS, CDER, US FDA Martin Kane, Associate Director Process Statistics, Department of Biostatistics, Human Genome Sciences, Inc. Justin McCue, Ph.D., Principal Engineer, Downstream Process Development, Biogen Idec Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc. Peter K. Watler, Ph.D., Chief Technology Officer, Hyde Engineering + Consulting Inc. Strategy Discussion Forums 10:15 Managing Partners and Contractors – Practical Solutions to the Issues that Arise As manufacturing partnerships and capacity “sharing” become more prevalent, companies are faced with the challenges and issues associated with managing these relationships. This session will present and discuss some of the pitfalls faced and will look at some of the solutions that have been tried (successful or otherwise). Topics such as intellectual property, timeline management and project scope creep will be discussed in addition to specific challenges raised from the panel or floor. If you are contracting or partnering to access or leverage capacity, this session will provide insight on specific challenges to expect and strategies for their management/resolution. Moderator: Susan Dexter, Senior Principal Consultant, BioPharm Services US Panelists: Pierre Beaurang, CMC Director, Five Prime Anne Collins, Ph.D., Hospira Inc., Australia Cyrus Karkaria, Ph.D., Vice President, Bioprocess Technology, Celldex Therapeutics Mark O'Mahony, Vice President, Process Development, Manufacturing and QC, Tolerx, Inc. Mark O’Neill, Director, CMO Business Development, Amgen Inc. Key Considerations when Screening Supplements for Medium Optimization The contribution of protein hydrolysates to the performance of a biopharmaceutical production system is largely medium dependent. The improper application of hydrolysates during medium optimization may result in decreased system performance and/or increased system variability. This medium dependence will be discussed, along with key elements of a suggested hydrolysate screening protocol that will help ensure effective evaluation of a supplementation scheme’s overall contribution to system performance. J.F. Babcock, Ph.D., Cell Culture Applications Manager, Sheffield Bio-Science 11:45 Concurrent Technology Workshops Maximizing Protein Expression in Suspension CHO Cell Transient Transfection Transient transfection allows researchers to bridge the development bottleneck and shorten the time to usable protein. CHO suspension cells are used for stable protein expression, despite being refractory to commonly used transfection methods (e.g. linear PEI). Mirus Bio has developed a more effective alternative, the TransIT®-PRO transfection reagent. Maximum transient expression is achieved through optimization of cell density, DNA concentration, quantity of transfection reagent, and media formulation. Laura Juckem, Ph.D., R&D Senior Scientist, Mirus Bio 12:15 Luncheon Presentation Efficient Packing of Biochromatography Media with Novasep Prochrom® Columns Novasep's new high performance low to medium pressure Prochrom® columns are made especially for biochromatography. The combination of a moving piston and valves with an automated packing unit makes their design special and allows various modes of efficient, effortless and fast "in place" packing. More particularly, "flow packing" and "dynamic axial compression packing" will be presented for a polymer-based media. Efficiency measurements and scale-up strategies will also be illustrated for these two packing modes. Michael LaBreck, Sales Manager - Biopharma, Novasep, Inc. A Novel to Approach to Integrate the Purification Process for Monoclonal Antibodies that Increases Processing Productivity As the demands and challenges associated with the purification of therapeutic proteins increase, new tools are needed. In this talk, the development of three chromatography media to enable improved process flexibility in terms of plant fit and buffer requirements will be described. Efforts to develop a flexible three step monoclonal antibody purification involving minimal buffer changes/dilution between process steps will be discussed. Optimization of a process using Protein A affinity capture directly eluted onto a cation exchange column followed by elution and direct loading of an anion exchange membrane adsorber will be used to describe the process flexibility benefits of these new purification tools Richard Pearce, Program Director - Purification Solutions, Millipore Corporation Managing Manufacturing Networks Smart Flexibility in Facilities 1:45 Chairperson’s Remarks Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden 2:00 New, Unpublished Data CASE STUDY Design and Operation of a Disposable Based Facility For a small, emerging biotechnology company, the timely delivery of preclinical and clinical material is extremely important to the early success of the company. The flexibility, cost, and ease of operation of a multiproduct facility based on disposable technology and delivered media and buffers provides an alternative to traditional stainless steel based designs or the use of contract manufacturing organizations. Robert J. Steininger II, Senior Vice President, Manufacturing, Acceleron Pharma 2:30 Design of a Protein A pH Gradient Elution Offers New Flexibility in mAb Processing pH gradient elutions on protein A enhanced the removal of process and product related impurities as compared to traditional step elution. The substantial purity improvement enables use of more streamlined membrane chromatography operations in place of downstream columns. Preparative and pilot-scale results for multiple mAbs suggest the technique is scalable and robust and may hold promise as a platform approach. Asha Radhamohan, Engineer I, Bioprocess Development, Genentech, Inc. 3:00 CASE STUDY Commissioning BioMarin’s Highly Disposable, Multi-Product Commercial Facility Starting up a flexible and disposable facility requires utilization of proven technologies while exploring and implementing novel applications. This presentation will review the complexities involved in BioMarin’s execution of commissioning and qualification of their newly expanded Commercial Operations facility located in Novato, California. Chris M. Brodeur, Senior Operations Manager, Commercial Expansion Head, BioMarin Pharmaceutical Inc. This session will be followed by a break-out discussion on the same topic on Thursday morning. 3:30 Networking Refreshment Break Product Lifecycle Management Implementation and Execution 1:45 Chairperson’s Remarks Cenk Undey, Ph.D., Senior Principal Engineer, Amgen Inc. 2:00 New, Unpublished Data CASE STUDY Update on the Implementation of QbD at Genentech and Participation in the FDA QbD Pilot Program Genentech is piloting implementation of QbD with a monoclonal antibody that is in Phase III development. As part of that effort, Genentech was successful at getting the late stage product into the FDA QbD Pilot Program. This presentation will include an update on the strategy and approach being taken to implement QbD, and the lessons learned from the Pilot Program to date. Vassia Tegoulia, Ph.D., Scientist, Pharma Technical Regulatory, Genentech, Inc. 2:30 Role of PAT in Operational Excellence Operational excellence involves continuously improving a business, i.e., process and performance, enhancing quality, and minimizing waste. Process Analytical Technologies (PAT) may create a synergistic effect in the operational excellence strategies employed in the bio/pharmaceutical companies. PAT’s role in the journey towards operational excellence in biopharma manufacturing environment will be discussed. F. Ceylan Erzen, Senior Engineer, Industrial Engineering, Amgen Inc. 3:00 New, Unpublished Data CASE STUDY Development of Robust Process Parameters for the Production of a Therapeutic Glycoprotein Derived from Glyco-engineered Pichia Pastoris In this case study, a robust manufacturing process was transferred to a CMO. In order to meet aggressive development time lines, design of experiments and ultrascale down models were used to identify the design space for each unit operation. The presentation will also discuss some relationships of process parameters to identified critical product quality attributes. Thomas Linden, Ph.D., Associate Director, Bioprocess R&D, Merck & Co., Inc. Co-authors: M. van Maanen; J. Pollard; R. Chmielowski; T. Potgieter 3:30 Networking Refreshment Break 1:45 Manufacturing: What will Take us to the Next Level of Efficiency and Economics Sponsored by Strategy Discussion Forums Biomanufacturing has matured over the last ten years with the implementation of more industrial practices and new, more flexible and efficient processes and technologies. Nevertheless, with the pending reforms in healthcare and the advent of biosimilars, price pressures are likely to drive a new level of cost efficiency in manufacturing. This panel will look at some of the bottlenecks and possible solutions for getting this next level. Issues discussed will include new technologies, the potential use of old/low cost technologies, regulatory and analytic hurdles and the implementation of industrial practices. Moderator: Peter Latham, President, BioPharm Services US Panelists: Shishir Gadam, Ph.D., Director, Manufacturing Science and Technology, Genentech, Inc. Dave Lescinski, Vice President, Chromatography, Pall Life Sciences Alison Moore, Ph.D., Vice President, Corporate Manufacturing, Amgen Inc. Thomas C. Ransohoff, Vice President and Senior Consultant, BioProcess Technology Consultants, Inc. Dr. Jens H. Vogel, Global CMC Development Team Leader and Head, Isolation and Purification, Bayer Healthcare Willard Waterfield, Ph.D., Senior Director, Manufacturing Sciences & Technology, Andover and Pearl River, Pfizer GMS 4:00 Regulatory Modernization - FDA's Desired State for Product Quality The Pharmaceutical Initiative of 2002 introduced the concept of improving the regulation of product quality throughout the pharmaceutical community. As a result, CDER initiated "quality by design" as a tool to assist industry in meeting higher product quality standards. Many innovator and generic firms have moved forward in implementing quality by design. This presentation will focus on the opportunities and challenges of implementing quality by design for biotech products. Helen N. Winkle, Director, Office of Pharmaceutical Science, CDER, US FDA Keynote Presentations Chairperson: Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc. 4:45 The Role of Biosimilars in Driving Innovation in the Biopharmaceutical Industry Over the past few years, biosimilars have emerged as an important new sector of the biopharmaceutical industry. The competitive nature of this new sector is encouraging innovation among leading biosimilar companies to bring differentiated and lower cost biologic products to patients. The introduction of biosimilar products is also likely to spur innovation from originator companies facing a more competitive marketplace. This presentation will explore the growing role of the biosimilars sector in driving innovation across the biopharmaceutical industry. Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc. 5:30 Opening Night Reception in the Exhibit and Poster Hall Sponsored by Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event 6
Wednesday, September 22, 2010 • Main Conference 7:00 Registration and Coffee 7:15 Technology Workshop (Light Continental Breakfast will be served.) Biological Assays for Characterization of Raw Materials Used in Mammalian Cell Culture Media Formulations SAFC Biosciences raw materials characterization initiative was established to evaluate variability in raw materials used to formulate cell culture media and thereby improve media consistency and performance in cell culture manufacturing processes. Cell-based biological assays were developed to investigate the effects of raw materials on cell growth, production and product quality. Biological assays were designed to include appropriate indicator cell lines, assay media and conditions to detect lot-to-lot variability among raw material suppliers Andrew Christie, Principal Scientist, Cell Sciences & Development, SAFC Biosciences Managing Manufacturing Networks Product Lifecycle Management Raw Materials/Supply Chain The Future of Manufacturing Networks and Facilities 8:00 Chairperson’s Remarks Alison Moore, Ph.D., Vice President, Corporate Manufacturing, Amgen Inc. 8:15 CMC-Related Regulatory Considerations for Development of Antibody-Drug Conjugates: An FDA Perspective Antibody-drug conjugates (ADCs) are designed to deliver a cytotoxic drug through a targeting moieties (e.g., tumor cells) utilizing the specificity of a monoclonal antibody. Although such ADCs are simple in principle, significant chemistry, manufacturing, and control (CMC)- related challenges arise during development and regulatory review. CMC-related issues unique to this class of molecules will be discussed. Jun Park, Ph.D., Regulatory Quality Reviewer, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, US FDA 8:45 Leveraging Innovation to Achieve Successful Strategies for the Biotech Business Based on a discussion of various elements of strategic uncertainty today, this talk will look at technology, financial, and strategic business aspects that in combination could form sources for success tomorrow. We will challenge the mainstream discussion of manufacturing issues and will provide a view on innovation that goes beyond what R&D alone can deliver. Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden 9:15 New, Unpublished Data CASE STUDY Development and Implementation of a Next-Generation Manufacturing Process for a New rFVIII Product Building on the experience with Bayer’s recombinant Kogenate® product line, the strategy of the BAY 81-8973 CMC development team was to utilize targeted innovation to develop, scale-up and implement a new, simplified and more efficient upstream and downstream manufacturing process. The resulting new technologies now also form the manufacturing platform for other complex biologics. Dr. Jens H. Vogel, Global CMC Development Team Leader and Head, Isolation and Purification, Bayer Healthcare 9:45 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by 10:30 Subcutaneous Protein Delivery: Challenges, Opportunities, and Key Lessons from a Drug Delivery Platform Biotech companies are often spending much effort concentrating mAbs to ≥ 100 mg/mL to accommodate subcutaneous dosing at high doses. Halozyme’s Enhanze Technology permits SC dosing of much greater than 1 mL/injection, which enables bypassing high concentration formulation challenges with the potential to allow rapid conversion of intravenous drugs to subcutaneous administration, which may benefit patients’ convenience and compliance. Michael J. LaBarre, Ph.D., Vice President, Product Development, Halozyme Therapeutics, Inc. 11:00 New, Unpublished Data CASE STUDY Biodefense: Human Genome Sciences’ Development and Manufacture of an Antibody for Treatment of Anthrax Delivered to the Strategic National Stockpile The anthrax attacks of 2001 reaped fear and panic in our nation. In response President Bush proclaimed "we will rally the great promise of American science and innovation to confront the greatest danger of our time." Eight years later Human Genome Sciences delivered the first doses of raxibacumab to the U.S. government. The antibody program and its unique twists and turns are chronicled. Craig Malzahn, Director, Supply Chain / Manufacturing Operations, Human Genome Sciences, Inc. 11:30 Upgrading Current Facilities for Future High Titer Processes Success in biopharmaceutical manufacturing is increasingly challenged by new production requirements, aggressive timelines and economic drivers. New product platform strategies and technologies, as well as process simulation tools have been incorporated to meet future manufacturing demands. The new upgrades will develop facility flexibility by increasing asset utilization, assist in long term capital planning of projects and coordinate cross site facility consistency. Rich Meinel, Associate Director Global Process Engineering Technology, Biogen Idec Continuous Process Improvement 8:00 Co-Chairpersons’ Remarks Maninder Hora, Ph.D., Vice President, Product Operations, Facet Biotech Ellen L. McCormick, Director, BioSciences Group, Pfizer, Inc. 8:15 New, Unpublished Data CASE STUDY A Continuously Evolving mAb Process Over the life cycle of a mAb, drivers such as supply demands, increased process knowledge, new technologies, regulatory standards and additions to manufacturing network all contribute in the decision to make process changes. This case study follows the strategy and challenges of a currently approved mAb purification process as it evolves from its original to its current and potential future state. Debbie O’Connor, Scientist, Late Stage Purification, Process R&D, Genentech, Inc. 8:45 New, Unpublished Data CASE STUDY Continued Understanding of Biopharmaceutical Production Processes Post-Validation Understanding of biopharmaceutical production process is a continuous task performed over the lifecycle of the product. Effective analysis of manufacturing data allows identification of trends and their potential root cause, as well as potential improvement opportunities within the design space. Procedures and case studies for effective process monitoring and identification and implementation of process and technology improvements will be presented. Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences Inc. 9:15 Humira Downstream Process: Challenges in Continuous Improvement and Technical Transfer Humira (adalimumab) was successfully launched in 2002. Currently, it is manufactured at 6,000-L to 12,000-L scales in different facilities. In the past years, continuous efforts have been made to enhance process robustness, to ensure the consistency of product quality and process performance at different facilities, as well as to satisfy and harmonize divergent global regulatory demands. QbD approaches have been applied to the process optimization with implementing better process control strategies. Helen Yang, Technical Operations, Abbott Bioresearch Center 9:45 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by 10:30 New, Unpublished Data CASE STUDY Utilization of QbD Principles for the Management of Post-Approval Changes Management of post-approval process changes for biotechnology products is well suited to the application of QbD principles and risk-based approaches. Here the application of QbD principles for the management of post-approval changes is applied to support drug substance changes intended to improve process efficiency, reduce raw material risks and support scale-up and process transfer. Marc Better, Ph.D., Executive Director, Process Development, Amgen Inc. 11:00 New, Unpublished Data CASE STUDY Advanced Process Control and Real- Time Chromatography Monitoring Liquid chromatography plays an important role in the purification of pharmaceutical products derived from biotechnology processes. Process-scale separations often involve multiple column operations, each consisting of multiple phases so column packing, qualification and process monitoring are important areas of concern. This presentation discusses Biogen Idec’s strategy for chromatography analysis and monitoring. This approach leverages the power of multivariate analysis, advanced analytical algorithms, and process knowledge to achieve the enhance process understanding and improved process performance. Robert Genduso, Scientist II, Biogen Idec 11:30 New, Unpublished Data Design of a Contamination Barrier for Serum- Containing Cell Culture Media of a Licensed Product Despite their infrequency, microbial, viral and mycoplasma contaminations of biomanufacturing facilities have had significant financial, production and regulatory impacts to companies. Robustness of the contamination barrier depends on the degree of inactivation/clearance conferred by treatment technologies and the risk of raw materials. HTST, UVC, viral filtration and gamma irradiation, as well as raw material decomposition strategies, were evaluated to overcome impact to process/product. R. Michael Boychyn, Ph.D., Principal Engineer, Amgen Colorado Process Development, Amgen Inc. 12:00 Concurrent Technology Workshops Point Counterpoint Session: Integrating Raw Materials and Suppliers into a Pharmaceutical Quality System 8:00 Co-Chairpersons’ Remarks: Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec 8:05 Risk Assessment and Management for Raw Materials A holistic risk assessment approach is described, including supplier capabilities, quality systems, and material safety data. In addition, an assessment of material properties on the process, which links parameters to critical quality attributes, is required. The information required is significant but the outputs can result in a clearer prioritization of the data required, more rational setting of specifications, avoidance of redundant testing and a better foundation for continuous improvement. Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. 8:30 Supply Chain Risk Management Methodologies Using case studies, this talk will demonstrate the usefulness of applying an analytical driven sourcing methodology to mitigate risks within a company's supply chain. In addition, this talk will address Biogen Idec's approach to ensure objectives of assurance of product supply, product quality and financial compliance within the supply chain through a instituting a decentralized GMP sourcing model. Issues like organizational approaches, governance structures, sourcing tools and risk management techniques will be discussed. Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec 8:55 Global Adventitious Agent Regulations of Raw Materials Used in Biopharmaceutical Manufacturing Abstract unavailable at press date. Please visit www.IBCLifeSciences.com/BPI for program updates. Barbara Potts, Ph.D., Senior Consultant, Biologics Consulting Group, Inc. Co-author: T.W. Tanaka 9:20 New, Unpublished Data CASE STUDY Supplier Perspective on Risk Assessment and Management of Critical Raw Materials for the Manufacture of Biological Therapeutics The pharmaceutical market is requiring greater characterization and transparency of the supply chain for critical raw materials used in manufacturing due to the continuing need to minimize variability and increased regulatory oversight. This presentation will focus on techniques for characterization and a case study on how these techniques improved our understanding of the solubility of these components to enhance the consistency of the manufacturing process. David Kolwyck, Technical Manager, SAFC, a division of Sigma Aldrich 9:45 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by 10:30 Implementing a Raw Materials/Supplier Management Risk Mitigation Strategy with Limited Resources • What do you do after you assess the risks • What can you use to compensate for identified risks-- short term and long term • Tactics for small firms • Leveraging information Paula Shadle, Ph.D., Principal Consultant, Shadle Consulting Services 10:55 New Applications of Analytical Methodologies for Raw Material Characterization Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for program updates. Maureen Lanan, Ph.D., Principal Scientist, Analytical Development, Biogen Idec 11:20 Audience Interactive Panel Discussion with All Session Presenters Achieving Reproducible Manufacturing Outcomes through the Use of Scale-down Models The use of accurate scale down modeling ensures that lab data represent the manufacturing case when transferring bioprocesses between sites. Diosynth has used a lab scale fermentation model to accurately reflect manufacturing operations, leading to successful scaling of five microbial processes over the last two years. Discussion will center upon how and when to use scale-down models to achieve reliable manufacturing results. Raghu Shivappa, Ph.D., Fermentation Team Leader, Upstream Process Development, Diosynth Biotechnology Stewart McNaull, Ph.D., Section Leader, Upstream Process Development, Diosynth Biotechnology Relieving Bottlenecks in Downstream Purification: Further Advances in Membrane Chromatography Part 1: Dr. Carl Lawton will present his recent work on scaling up purification of E. coli expressed proteins using single step capture and clarification. Carl W. Lawton, Ph.D. Associate Professor, Biological Engineering Program Coordinator, Director, Massachusetts BioManufacturing Center (MBMC) Part 2: Novel Chemistries for High-Capacity / High-Throughput Single-Use Membrane Chromatography C Howie Honeyman, Ph.D., Vice President, Research and Product Development, Natrix Separations Inc. Fully Disposable, Multiple mAb Processing for Clinical Trials A step-by-step review of a typical mAb platform process from inoculation to final filtration will provide solutions for single- or campaign-use technology as well as technical and economical criteria to decide what the best alternative would be: a classic equipment setup or the disposable option. Jonathan Royce, Category Leader Bioprocess, GE Healthcare Life Sciences 12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing Poster presenters are requested to stand by their posters for discussion. CelliGen BLU: How New Brunswick has Combined the Performance of Stirred Tank Technology with the Benefits of Single-Use The CelliGen BLU is New Brunswick’s newest offering in the benchtop bioreactor and fermentor family of products. Positioned as a novel system offering 5.0L or 14.0L stirred tank single-use vessels; this system mimics traditional autoclavable technology while providing all the benefits of disposable technology. The CelliGen BLU will meet the demands of the single-use system users not satisfied with the current bench scale single-use bioreactors available on the market. Richard Mirro, Product Manager, New Brunswick Scientific 7 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
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