27 30 October 2015 Grand Copthorne Waterfront Hotel, Singapore. Enhancing Efficiency & Quality in Antibody & Vaccine Production

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1 IBC LIFE SCIENCES Part of: October 2015 Grand Copthorne Waterfront Hotel, Enhancing Efficiency & Quality in Antibody & Vaccine Production 2015 EXPERT FACULTY INCLUDE: KEY CONFERENCE THEMES INCLUDE: Pierre A. Morgan Chief Executive Officer, AJ Biologics, Malaysia Christian Cater Head, Operational Excellence, Novartis Pharmaceutical Alain Bernard Vice President, Head of Global Technical Operation Business Excellence, UCB, Belgium Steven Lee Global Head, Technical Operations & Chief Executive Officer, Dr. Reddy s Laboratories, Joe Zhou CEO, Genor Biopharma & Vice President, Walvax Group, China Wu Ke President, Shanghai BravoBio, China Update yourself with latest technologies to accelerate every stage of bioprocess From cell culture and scale up to downstream purification, with maximum efficiency and quality Antibody-focused track Covers key challenges in screening, process optimization, scale up and downstream challenges with regards to mabs, biosimilars, fusion proteins and ADCs Vaccines-focused track Involves latest updates and trends in halal vaccines, tackling challenges in multi-valent vaccines, and improving quality processes Exclusive case studies from top companies discussing their best practices and latest technologies employed in bioprocessing, facility design and operational excellence in production PLUS-WORKSHOPS NOT TO BE MISSED Pre-Conference Workshop A: 27 October am 4pm Efficient & Effective Statistical Approaches for Ease of Method Validation Transfers Post Conference Workshop B: 30 October am 4pm Novel Design of Experiments (DOE) Approaches for Optimization and Effective Process Characterization Co-located: Produced by: Life Sciences Sponsor: Media Partners: International Marketing Partner:

2 CONFERENCE DAY ONE 28 OCTOBER 2015 WEDNESDAY 8.00 Registration Opens & Morning Coffee 8.50 Welcome Address from IBC Asia & Speed Networking Asia Biopharma Development & Production Market Outlook 9.00 Chairperson s Opening Remarks 9.10 Optimising Biologics Manufacturing & Developing Strategies for Innovation and Efficiency Major cost drivers of biologic manufacturing and assessing their impact on manufacturing efficiencies Comparing worldwide biologic manufacturing capacity, development, evolution and utilization Evaluating various manufacturing strategies and finding your right model to achieve innovation and efficiency Steven Lee, Global Head, Technical Operations & Chief Executive Officer, Dr. Reddy s Laboratories, 9.50 Evaluating Biosimilar Investment & Development in Asia Size, potential and challenges of the Asia biosimilars market What has hindered growth and what are investors waiting for? What is required to build up the biosimilars pathway and biosimilar capacity in Asia? Who are the leading biosimilars companies in the region? What are the priorities for local pharma? What are the current barriers to entry? Direction of Asia s biosimilar development Moderator: Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, Switzerland 12:40 Networking Lunch Panelists: Steven Lee, Global Head, Technical Operations & Chief Executive Officer, Dr. Reddy s Laboratories, Sarfaraz K. Niazi, Executive Chairman, Therapeutic Proteins International LLC, USA George Wang, Founder and Chief Executive Officer, Mab-Venture Co. Ltd., China Ming Wang, Vice President, Diabetes Disease Area Leader, Janssen Pharmaceuticals, USA Morning Networking & Refreshment Break Next Generation Plants & Operational Excellence Chairperson s Opening Remarks Futuristic Features of a Next-Generation, Green Bioprocessing Plant Hybrid facility designs High titre processes Feasibility considerations and process design Joe Zhou, CEO, Genor Biopharma & Vice President, Walvax Group, China Successful Lean Manufacturing & Operational Excellence within a Regulated Industry Benefits and challenges of incorporating operational excellence Examples of transformation plans Using lean six sigma in a pharmaceutical environment Advances in operational excellence in the regulated industries ANTIBODIES 1.55 Chairperson s Opening Remarks VACCINES Chairperson s Opening Remarks Advancements in Gene Expression & High Throughput Screening for Antibodies Development 2.00 Rapid Cell Line Development for mabs with Targeted Genome Engineering for Efficient Expression Drawbacks of currently used random integration-based cell line development Advantages and challenges of targeted integration-based cell line development Strategy for efficient identification of hotspots that provide stable and high level gene expression Characterization of targeted cell lines for productivity, production stability and product quality Yuan Sheng Yang, Senior Staff Research Scientist, Bioprocessing Technology Institute, 2.40 Manufacturing Technology and Cell Line Selection: Microbial vs Mammalian Cell Comparing Microbial and Mammalian cell expression technologies from a process development and manufacturing point of view Cell Expression technologies from regulatory, quality, lead time and of course economic point of view Cost of goods and fit with product type, use and dosage Alain Bernard, Vice President, Head of Global Technical Operation Business Excellence, UCB, Belgium 3:20 Afternoon Networking & Refreshment Break Market Overview of Vaccines Developments & Key Trends Overview of Vaccines Landscape & Halal Vaccines Key Trends Drivers of vaccine acceptability compared to therapeutic products Key determinants of the immunization decisions for each type of stakeholders in the fragmented vaccine landscape Focus on consumer motivation and behavior, dealing with anti-vaccine sentiment and misinformation How to drive positive awareness, perception and expectations about Halal vaccines Pierre A. Morgon, Chief Executive Officer, AJ Biologics, Malaysia Vaccines Fulfilling Unmet Medical Needs in Asia Meeting unmet needs in vaccines development- Vaccines count, and make a difference! Innovative strategies to improve patient access to vaccination Case study: India s success with polio vaccine - what can we learn and apply in developing countries Efficient Bioprocess Design & Scaling Up Strategies 3:50 Ensuring Success in Scaling up the Cell Culture Process Strategies to maximize productivity, enhance process reproducibility and facilitate scale-up Being aware of scale-up effects on process performance and product quality Questions and considerations when moving to production scale Single-use disposable/ miniature bioreactors High-titre cell culture processes and scale up strategies Vaccine Manufacturing in SEA and Beyond Trends in Vaccines developments and where are the current and future predictions in types of vaccines research, production and investments Overview of regional and global trends Anil Sood, Vice President, Panacea Biotech, India Pierre A. Morgon, Chief Executive Officer, AJ Biologics, Malaysia Process Advances in Biosimilar Production 4:30 Incorporating the Modularity Strategy in Process Development for Biosimilar Production Understanding the strategy and the difference for process development for biosimilar vs innovative drugs Designing the modular unit operation (MUO) to reduce the time and cost expending in biosimilar process development in order to speed-up the firstto-market agenda Modularity processing creates more opportunity to implement the integrated single-use systems in biosimilar manufacturing Case study: the concept of Modular Unit Operation (MUO) and modularity elements to construct the entire manufacturing processes Jason Li, Director, WuXiApptec Biopharmaceuticals Co. Ltd, China Overcoming Challenges in Developing Combination Vaccines Tackling Challenges in Manufacturing Multi-Valent Combination Vaccines Difficulty in predicting the physical compatibility and stability of antigens in combination Use of appropriate animal models for the evaluation of potential modifications of antigen efficacy Mitigating the resulting supply chain challenges due to batch release testing and storage of intermediate products Anil Sood, Vice President, Panacea Biotech, India 5.10 Chairman s Closing Remarks & End of Conference Day One

3 CONFERENCE DAY TWO 29 OCTOBER 2015 THURSDAY 9:00 Chairperson s Opening Remarks Joe Zhou, CEO, Genor Biopharma & Vice President, Walvax Group, China Tech Transfer Best Practices & Single Use Systems 9:10 Best Practices in Adapting to Single-Use Systems Trends in moving towards single use systems Hybrid approaches Miniature bioreactors- scale up from small scale reactors Risk mitigation strategies Joe Zhou, CEO, Genor Biopharma & Vice President, Walvax Group, China Elango Shanmugam, Process Development Lead, Pfizer Jason Li, Director, WuXiApptec Biopharmaceuticals, China 9.50 Process Tech Transfer to Multiproduct Facilities Ensuring smooth scale-up and well-prepared technical transfer Examine how new trends and developments in process technology is best developed and translated to a GMP-robust manufacturing environment Project management and communication Elango Shanmugam, Process Development Lead, Pfizer Morning Networking & Refreshment Break 1:00 Networking Lunch ANTIBODIES Latest Technologies & Techniques for Improved Process Development 2.20 Continuous Manufacturing: Upstream vs. Downstream Issues & Points to Consider for Antibody Processing Feasibility of continuous manufacturing PAT for continuous processes Defining batch or lot for release Effective control strategies Risk mitigation strategies Jason Li, Director, WuXiApptec Biopharmaceuticals Co. Ltd, China Yuan Sheng Yang, Senior Staff Research Scientist, Bioprocessing, Technology Institute, Quality & Regulatory Compliance Best Practices in Regulatory Strategies for Biomanufacturing Addressing CMC variations in regulatory requirements across the region Upcoming GMP changes to the EU and PIC/S GMP guides Best practices in regulatory submissions cgmp Manufacturing best practices for efficient certification and approvals Malini Sen, Director, Quality Assurance, Biocon Malaysia Tong-Lay Crystal Lau, Senior Technical Regulatory Specialist (Global), GSK, 11:40 The Changing faces of Regulatory Inspection How the inspection strategy has changed the past decade Importance of data integrity during inspections How to effectively prepare yourselves for regulatory inspections Malini Sen, Director, Quality Assurance, Biocon Malaysia Strategic Partnerships for Efficient Bioproduction 12:20 Finding Symbiotic Partnerships to Accelerate Biologics Production & Market Launches Current trends of partnerships in the region with other pharma players Points to consider for partnerships with CMOs Risk mitigation and negotiation strategies Determining the fit with your company How to leverage strengths for competitive advantage VACCINES 2.15 Chairperson s Opening Remarks Chairperson s Opening Remarks :40 Afternoon Networking & Refreshment Break 4.20 Optimizing Process Development for Monoclonal Antibodies Therapeutic antibodies the Challenge: produce large quantities with cost and time efficiency Improving the fermentation process Chemically-defined, animal component free and protein-free media Challenges in ADC Development Overcoming Characterization and Stability Testing Challenges for ADC s Antibody-drug conjugates (ADCs) have unique attributes that pose challenges in the manufacturing and characterization Strategy for developing a thorough characterization plan for product and process Defining the ADC critical quality attributes Understanding the degradation pathways Identify appropriate stability indicating and characterization assays Shan Jiang, Director, Formulation and Fill/Finish, Seattle Genetics, USA Process Improvements in Vaccines Manufacturing Production and Purification of Virus like particle (VLP) based Vaccine Generic process for virus like particle based vaccine Optimization of upstream process for production in single use bioreactor Improvement of downstream process to achieve process compression Priyabrata Pattnaik, Director - Worldwide Vaccine Initiative, Merck Millipore, Can Continuous Processing and Single-Use Benefit Vaccine Manufacturing? Current Vaccine manufacturing production methods have remained batch in stainless steel Key factors to move from batch to continuous processing in single-use systems Addressing technical, scientific, and cost savings, commercial drivers for this shift Panelists: Wu Ke, President, Shanghai BravoBio, China Manyank Garg, Assistant GM, Head of Manufacturing & Process Control Strategy, Shantha Biotechnics Ltd, A Sanofi Company, India Regulatory Strategies for Vaccines Developments CMC Regulatory Strategies for Vaccines Registration New manufacturing site registration (Vaccines) Comparability protocol for new manufacturing site registration Lifecycle of drug product with multiple drug substances Best practices in regulatory submission Tong-Lay Crystal Lau, Senior Technical Regulatory Specialist (Global), GlaxoSmithKline, Improving Quality Processes 5.00 Modelling & Process Control Strategies for Efficient Manufacturing Key focus on continuous improvement and Quality by Design (QbD) How statistical process control strategies might help in process characterization post commercial launch ROI of a Real-Time SPC solution Manyank Garg, Assistant GM, Head of Manufacturing & Process Control Strategy, Shantha Biotechnics Ltd, A Sanofi Company, India 5:50 Chairperson s Closing Remarks & End of Conference Purification & Downstream Processing Essentials Removal of Host Cell Residuals for Increased Quality in Vaccine Production Improving clearance in early steps of downstream processing Host cell DNA removal in vaccines purification Wu Ke, President, Shanghai BravoBio, China

4 WORKSHOPS Pre-Conference Workshop A: 27 October 2015 Tuesday 9.00am pm Efficient & Effective Statistical Approaches for Ease of Method Validation Transfers The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that the methods are fit for purpose. To demonstrate that a method is fit for purpose will require either a validation, verification or transfer study, depending on the source of the method in question. Learning Objectives: Introduction to equivalence testing Basic descriptive statistics Regulatory framework Why is equivalence testing important Showing equivalence v. Meeting specifications Understanding where equivalence testing is needed Product transfers Method validations Example of equivalence testing Product transfer example About Your Workshop Leader Christian Cater Head, Operational Excellence, Novartis Pharmaceutical Manufacturing, Mr. Christian Cater is the Head of Operational Excellence at Novartis Pharmaceutical Manufacturing. Mr. Cater has studied at major universities within the United States including West Virginia University and MIT. He earned a Master s Degree in Industrial Relations and an Executive Education Certificate from MIT. Throughout his career, Mr. Christian Cater has lead business transformation initiatives within fortune 500 companies that focus on implementing robust problem solving cultures. He is responsible for developing and training personnel to excel at critical thinking and solving business problems for Novartis. Mr Cater has over 18 years of experience in the pharmaceutical industry and having assumed many important positions in relation to Continuous Improvement and Operations management throughout the years. Post-Conference Workshop B: 30 October 2015 Friday 9.00am pm Novel Design of Experiments (DOE) Approaches for Optimization and Effective Process Characterization Learning Objectives: Understanding the relationship between DoE and QbD Introduction to experimental design techniques and software Key difference in DoE approaches for process optimization and process characterization Efficient DoE approaches to work within fixed research budgets and timescales Case Studies process optimization and characterization Industrial analytical method validation using DoE About Your Workshop Leader Manyank Garg Assistant GM, Head of Manufacturing & Process Control Strategy, Shantha Biotechnics Ltd, A Sanofi Company, India Mr. Mayank Garg is currently Heading Modelling and Process Control Strategies (MPCS) group at Shantha Biotechnics (A Sanofi Company). He is responsible for improving Industrial Performance of Vaccine manufacturing by establishing Statistical Process Control and Knowledge Management systems. With more than 14 years of experience in Biopharmaceutical industry, he has been involved at various stages of product lifecycle including Up-stream process development, Process Characterization, Validation, Statistical Process control (SPC) and Continuous Improvement. Prior to Sanofi, he has worked with Dr. Reddy s Lab, Intas Biopharma and Biocon. He has supported several CROs as consultant in the areas of process development and technical training. He received his Masters of Technology degree in Bio-process Engineering from Jadavpur University, Kolkata.

5 IBC LIFE SCIENCES Part of: October 2015 Grand Copthorne Waterfront Hotel, Enhancing Efficiency & Quality in Antibody & Vaccine Production The Bioprocess & Technology Conference 2015 brings together international leaders to discuss relevant and key issues involved in developing antibodies and vaccines to meet the growing demand. This meeting will examine the latest regulations, cutting edge, cost saving technologies, and discuss best practices to meet the huge growth and demand of biologic products in Asia. Companies will address efficiency measures, such as streamlined and continuous processing, analyze how to lower production costs, and examine the integration of single-use technologies and current trends in next generation bioprocessing. There will be two tracks on Antibodies & Vaccines which will enable more detailed and in depth discussions on overcoming specific process development challenges on these biologics. Gain best practice tools and process strategies which will increase efficiency, productivity and ensure quality in production for companies of all sizes. Top Reasons to Attend Exclusive case studies from regional and international leading top companies Two special focused tracks- Antibodies & Vaccines Attractive program covering depth and breadth of pertinent and key issues Benchmark your current strategies against industry best practices Implement next generation bioprocessing trends and technologies in your company for cost savings, higher productivity and quality Network with industry thought leaders and peers from top leading companies operating in the region Who You Will Meet: BY INDUSTRY: BioPharma/Biotech 50% CMOs 15% Technology & Solution Providers 30% Government/Research Institutes 5% BY COUNTRY: 40% Malaysia 20% Rest of SEA 10% India 5% China 5% Japan/Korea 10 % Europe/USA 5% Australia/NZ 5% Sponsorship Solutions Can Be Tailored to Your Needs! To position your company as a market leader at this event, and to explore the range of thought leadership, speaking, branding and marketing opportunities available, please contact Yvonne Leong, Business Development Manager on or yvonne.leong@ibcasia.com.sg

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