Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Manufacturing Success

Transcription

1 Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Manufacturing Success Co-Located with Single-Use Applications Flexible Facilities March 30 - April 2, 2015 Hyatt Regency Resort & Spa Huntington Beach, CA Gain strategies to avoid pitfalls, maximize efficiencies and alleviate bottlenecks with elaborate coverage of manufacturing technologies for emerging biologics. Apply newfound knowledge gained from 180+ speakers and demo new technologies from 70+ exhibitors for immediate advancements of your process and products. Enjoy fun and casual networking functions built in to connect with 800+ peers from multiple disciplines, including the all-popular BDP Beach Party! Hear Product and Production Visionaries Manufacturing in a Global Marketplace Engineering Novel Proteins Innovations in Biologics Manufacturing Development Challenges and Opportunities Tae Han Kim Samsung BioLogics James Swartz, Ph.D. Stanford University Hitto Kaufmann, Ph.D. Sanofi Biologics Dana Andersen, Ph.D. Genentech, Inc. Register Early and Save: #BDPWeek

2 BDP Week: Your 360 experience in everything biopharmaceutical development & production. From knowledge and networking to today s hottest technologies and services BDP Week has it all under one roof! 360 Engagement 800+ Attendees, 180+ Speakers, including 15 International Perspectives, 50+ Sessions, 85+ New Data Presentations, 80+ Case Studies, 80+ Scientific Posters, 11 Interactive Q&A Sessions, 70+ Exhibitors More Manufacturing Programming than Ever Before Progress is impossible without change, and when it comes to biopharmaceutical development and production, the pipeline and facility needs will forever be in a constant stage of intricate transformation. BDP Week is on the pulse of that change, keeping you ahead of that curve, with more manufacturing programming from two co-located events, Single-Use Applications and Flexible Facilities. No other event dials you into such an in-depth, comprehensive concept-to -commercialization experience that will ultimately enhance your biologics portfolio and operation from upstream to downstream and beyond. Get the Complete BDP Experience All Access Pass Get the complete BDP Week experience when you register for the BDP Week All Access Pass. This pass offers you the best value and access to everything the event has to offer. Media Partners: FierceBiotech THE BIOTECH INDUSTRY S DAILY MONITOR 2 For up-to-date program information and new abstracts, visit:

3 "Great week, receiving knowledge about process validation from industry leaders and experts" - Michael Lau, Process Scientist, Regeneron The development and production path presents many challenges. So whether it s a solution or strategy to overcome complex drug and manufacturing challenges or networking and collaboration opportunities in a unique and evolving biopharmaceutical marketplace, you and your colleagues will certainly benefit by attending BDP Week Reasons to Attend Overcome unique development and production challenges for 1. next generation biotherapeutics Innovate at the interfaces to streamline productivity 2. Maximize operational efficiencies 3. Enhance lifecycle management to guarantee reproducible results 4. Avoid pitfalls from bench to commercial scale from real world 5. case studies and lessons learned Discover cost efficient solutions for evolving marketplace needs Accelerate your research process for future planning and purchasing decisions Gain perspectives from small, mid-size and large companies, regulatory bodies, end-users, suppliers, virtual companies and academia Avoid adverse events that may negatively impact production and brand equity Alleviate bottlenecks that negatively impact process efficiency with new disruptive technologies Agenda at-a-glance....4 Keynote Presentations...5 Networking Schedule Sponsors and Exhibitors...22 Hotel...23 TABLE OF CONTENTS Pricing Agenda: Antibody Drug Conjugates Upstream Processing Downstream Processing Manufacturing Efficiencies Single-Use Flexible Facilities Analytical Methods & Technologies Quality & Control , Bispecific Antibodies Manufacturing Monitoring & Controls...21 Register Early for Best Savings

4 There's Something for Everyone at BDP Week 2015 Get out of the office and join a how-to environment that lets you concentrate on development and production challenges in the most effective and efficient ways possible. No matter where you work in the development and production path, everyone in your organization can get the knowledge they need at BDP Week. Monday, March 30 Antibody Drug Conjugate Development & Production Quality and Regulatory Considerations for ADCs New Modalities and Next Generation ADCs Challenges in Development and Production Upstream Processing Keynote Presentations Cell Line Development & Engineering Technology Workshops sponsored by GE Healthcare and Sartorius Stedim Networking Luncheon in Poster and Exhibit Hall Improving and Controlling Process and Product Quality / Impact of Cell Culture on Critical Quality Attributes NEW Single-Use Applications Ensuring Successful Single-Use Implementation and Integrity Single-Use Implementation and Transfer Case-Studies BPSA Roundtable BDP Big Top Reception in Poster and Exhibit Hall Agenda at-a-glance Tuesday, March 31 Wednesday, April 1 Antibody Drug Conjugate Development & Production Upstream Processing NEW Single-Use Applications Analytical Characterization for ADCs Media Development Optimization Single-Use Considerations for Cell Culture Applications Process Development Approaches Scale Up, Facility Fit & Implementing Single-Use Systems for Manufacturing ADCs Formulations and Fill/Finish for ADCs Single Use Applications in Upstream Processing Technology Workshop sponsored by Levitronix and EirGenix Networking Luncheon in Poster and Exhibit Hall Novel Approaches to Emerging Modalities and Process Intensification Approaches to improve Efficiencies and Reduce Timelines from Discovery to Clinic to Commercial Production and Regulatory Considerations for Single-Use Overcoming Challenges Associate with Particles and Extractables & Leachables Back by Popular Demand: BDP Beach Party Networking Cocktail Reception Co-Sponsored by SAFC and IBC Lifesciences Downstream Processing Advances at Harvest Step Manufacturing Efficiencies: Strategy & Technology Keynote Presentations Strategies for Supply Chain Management, Facility Fit and Biomanufacturing Capacity NEW Flexible Facilities Non-Classified, Closed and Other Considerations and for Single-Use Implementation Technology Workshops sponsored by GE Healthcare, Life Technologies/Thermo Scientific Networking Luncheon in Poster and Exhibit Hall Process and Facility Design Strategies and Considerations Continuous Processing Process Development and Manufacturing Strategies International Food Festival Networking Reception in Poster and Exhibit Hall sponsored by Patheon Thursday, April 2 Downstream Processing Integrating Disposables (Clinical and Commercial) in Downstream Processing Approaches to Improve Efficiencies and Reduce Timelines Automated and High Throughput Process Development Advances in Modeling and Characterization to Better Predict, Understand and Control Downstream Processes Manufacturing Efficiencies: Strategy & Technology Process Portability and Technology Transfer Manufacturing for Global Markets Technology Workshop sponsored by NNE Pharmaplan Networking Luncheon in Poster and Exhibit Hall BPOG Session Biomanufacturing of the Future NEW Flexible Facilities Design, Management and Implementation Considerations for Flexible Facilities 4 For up-to-date program information and new abstracts, visit:

5 New this Year! In addition to more manufacturing programming with the co-location of Single- Use Applications and Flexible Facilities, BDP Week also features expanded coverage of Analytical Methods & Technologies and a full day on Bispecific Antibody and Production. Whatever challenges you face, you will find the updates, solutions and strategies you need to advance your biologics and manufacturing programs. Analytical Methods & Technologies Exhibit Hall & Poster Viewing Hours: 9:45 am 6:45 pm Quality and Control Keynote Presentations Comparability Strategies for Biosimilars and Other Meet the New Challenges of Biotechnology Products Process Validation Technology Workshops sponsored by GE Healthcare and Sartorius Stedim Networking Luncheon in Poster and Exhibit Hall Comparability Strategies for Biosimilars and Other Biotechnology Products Development of Biosimilars Take the Next Steps in Process Validation Innovation BDP Big Top Reception in Poster and Exhibit Hall Exhibit Hall & Poster Viewing Hours: 9:45 am 3:30 pm Analytical Methods & Technologies Quality and Control Analytical Characterization for ADCs QbD/CQA Concepts from Development to Submission Viral Safety Technology Workshop sponsored by Levitronix and EirGenix Networking Luncheon in Poster and Exhibit Hall Analytical Characterization Methods for Critical Quality Attributes Aggregation and Subvisible Particle Analysis in Protein Drug Products Innovative Uses and Upcoming Challenges for Nanofiltration Risk Assessments Via HTST Treatments Back by Popular Demand: BDP Beach Party Networking Cocktail Reception Co-Sponsored by SAFC and IBC Lifesciences Exhibit Hall & Poster Viewing Hours: 9:45 am 6:45 pm Analytical Methods & Technologies Quantitation and Control Strategies for HCPs Keynote Presentations NEW Bispecific Antibody & Production Molecule Design and Development Strategies to Improve Solubility, Stability, Manufacturability, Half-Life of Bispecific Antibodies Technology Workshops sponsored by GE Healthcare, Life Technologies/Thermo Scientific Networking Luncheon in Poster and Exhibit Hall Total Control Strategies for HCP Control High-Throughput Methods and Strategies Development of Generic or Platform Production Process - Challenges and Solutions International Food Festival Networking Reception in Poster and Exhibit Hall sponsored by Patheon Exhibit Hall & Poster Viewing Hours: 9:45 am 3:30 pm Analytical Methods & Technologies Manufacturing Monitoring and Control Managing Raw Materials Quality Control Aggregation and Subvisible Particle Characterization and Control Inspection, Enforcement and Evolving Biological Standards Trends Technology Workshop sponsored by NNE Pharmaplan Networking Luncheon in Poster and Exhibit Hall Operational and Technology Consideration for Environmental Monitoring Product and Process Methods and Strategies for Glycan Analysis Manufacturing Control Strategies Monday, March 30 Tuesday, March 31 Wednesday, April 1 Thursday, April 2 "This is an excellent place to get an update on what's happening and what's new in bioprocessing" - Venkat Mangalampalli, Staff Scientist, Vaccine Production Program Lab, VPP NIH Keynote Presentations Manufacturing in a Global Market Place TH Kim, Ph.D., President and CEO, Samsung BioLogics Engineering Novel Proteins and Protein Assemblies as Innovative Therapeutics, Vaccines, and Drug Delivery Vehicles James R. Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University Innovation in Biologics Manufacturing Hitto Kaufmann, Ph.D., Vice President Technology and Development Biologics, Sanofi Biologics Challenges and Opportunities in Pharmaceutical Development Dana Andersen, Ph.D., Senior Director, Genentech, Inc. SESSION HIGHLIGHTS Keynote or Featured Presentation Case Study New Data Panel Discussion Register Early for Best Savings

6 Track Spotlight Antibody Drug Conjugates Capitalizing on recent industry achievements, this track will showcase how companies are successfully implementing novel approaches to improve the development, scale up, formulation, production and transfer of ADCs. Starting with the most recent accomplishments in R&D and the clinic, this track will explore the evolution in development to produce the next generation of ADCs that are more potent, stable, and have dramatically increased therapeutic windows. Upstream Processing From cell line engineering to the harvest step, this track covers all the critical components in upstream processing to help you improve cell culture productivity, product quality, and efficiency. Sessions will cover the latest integration of novel technologies, platforms, and approaches that cross multiple disciplines to streamline process development and dramatically reduce time to large scale production. Single-Use Applications Avoid pitfalls from bench to commercial scale from real world case studies and lessons learned. Hear case studies on effective deployment of single-use technology. Learn how to optimize time-tomarket by overcoming complex drug product and manufacturing challenges through actual, in-situ case studies using disposable technologies. Analytical Technologies A must-attend track for scientists seeking novel analytical methods for accurate characterization of biologics. From comparability and characterization strategies to QbD concepts to aggregation and subvisible particle analysis, get the tools and applicable knowledge you need to enhance your operation s process and product quality. Quality and Control Develop your quality assurance and quality control policies through risk-based and quality-centric strategies. Benchmark your process validation and viral safety protocols. Understand and meet compliance expectations for environmental, contamination, and manufacturing controls. Antibody Drug Conjugate Development & Production Monday, March 30, :00 Registration and Coffee Keynote Presentations Upstream Processing 8:00 Chairperson s Opening Remarks Karol Lacki, Ph.D., Staff Scientist, Research & Development, GE Healthcare Biosciences AB, Sweden 8:15 Presentation TBA 9:00 Challenges and Opportunities in Pharmaceutical Development Dana C. Andersen, Ph.D., Senior Director, Pharmaceutical Development, U.S. Biologics Technical Development, Genentech - a Member of the Roche Group 9:45 Networking Refreshment Break in Poster and Exhibit Hall 10:25 Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas Quality and Regulatory Considerations for ADCs 10:30 Regulatory Considerations for ADC Development Regulatory Reviews, CMC Challenges, and Non-Clinical Requirements Karen Cha, M.A., MBA, Director, Regulatory Affairs, Agensys, Inc. 11:00 Strategies for Setting Specifications for ADCs Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc. 11:30 Impact on New Linker Payloads on Drug Substance Quality Attributes and Process Solutions Olivier Marcq, Ph.D., Senior Principal Scientist, Pfizer Biotherapeutics R&D, Pfizer 12:05 Single-use Fermentation: Understanding Process Economy and Process Performance Ken Clapp, Product Manager, Bioreactors, GE Healthcare Trent P. Munro, Ph.D., Principal Scientist, Process Development, Amgen Inc. Cell Line Development & Engineering Less is More: Disruptive Technologies for Cell Line and Process Development for Large Scale Manufacturing Florian Wurm, Ph.D., Professor of Biotechnology, Swiss Federal Institute of Technology Lausanne, Switzerland An Integrated Cell Line Development Development Platform for Generation of High Yielding CHO and 293 Stable Cell Lines Expressing Monoclonal Antibodies and Recombinant Viral Glycoproteins Althaf Hussain, Ph.D., Director, Cell Line and Pre-clinical Development, Vaccine Production Program Lab, Vaccine Research Center, NIH Platform High-throughput Clone and Cell-line Selection Process for a Protein Therapeutic Bruce Tangarone, Associate Director, Analytical Development, Shire HGT Technology Workshop Presentation Fit For Purpose Design and Implementation of Single-Use Bioprocessing Plants Thorsten Peuker, Vice President, Integrated Solutions, Sartorius Stedim Biotech 12:35 Networking Luncheon in Poster and Exhibit Hall 6 For up-to-date program information and new abstracts, visit:

7 Monday, March 30, 2015 NEW Single-Use Applications Analytical Methods Technologies 7:00 Registration and Coffee Quality and Control Keynote Presentations 8:00 Chairperson s Opening Remarks Karol Lacki, Ph.D., Staff Scientist, Research & Development, GE Healthcare Biosciences AB, Sweden 8:15 Engineering Novel Proteins and Protein Assemblies as Innovative Therapeutics, Vaccines, and Drug Delivery Vehicles James R. Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University 9:00 Challenges and Opportunities in Pharmaceutical Development Dana C. Andersen, Ph.D., Senior Director, Pharmaceutical Development, U.S. Biologics Technical Development, Genentech - a Member of the Roche Group 9:45 Networking Refreshment Break in Poster and Exhibit Hall 10:25 Mark A. Petrich, Ph.D., Associate Director, Component Engineering, Merck & Co. Ensuring Successful Single-Use Implementation and Integrity 10:30 Best Practices For Testing Integrity of Single-Use Systems in Bioprocesses Weibing Ding, Ph.D., Principal Scientist, Materials Science, Amgen Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia Formulation & Delivery Developments Developing Drug/Device Combination Products for Oral Inhalation Andrea Leone-Bay, Vice President, Pharmaceutical R&D, MannKind Donald Singer, Global Lead Quality Manager, Building Mass Spectral Libraries for Microbiology, R&D, GlaxoSmithKline Meet the New Challenges of Process Validation Best Practices for Bringing Legacy Products up to Current Process Validation Standards Monica Lent, Head of Process Validation and Knowledge, Genentech 11:00 A Point of Use Method for Leak Prevention in Single-Use Process Containers Adam Sokolnicki, Biomanufacturing Engineer, EMD Millipore Comparability Strategies for Biosimilars and Other Biotechnology Products Building Mass Spectral Libraries for the NISTmAb Reference Material M. Lorna De Leoz, Ph.D., NIST Mass Spectrometry Data Center, National Institute of Standards and Technology Overcoming Regulatory Challenges with Endotoxin Recovery Studies During Process Validation Donald Singer, Global Lead Quality Manager, Microbiology, R&D, GlaxoSmithKline 11:30 Single Use System Implementation Case Studies Mark A. Petrich, Ph.D., Associate Director, Component Engineering, Merck & Co. Case Studies on Comparability Assessment of Biological Drug Products Camellia Zamiri, Ph.D., Scientist, Genentech, a Member of the Roche Group How Bristol-Myers Squibb Uses the FDA s Breakthrough Therapy Designation Kristen Manchester, Scientist, Manufacturing Sciences and Technology, Bristol-Myers Squibb 12:05 Single-use Fermentation: Understanding Process Economy and Process Performance Ken Clapp, Product Manager, Bioreactors, GE Healthcare Technology Workshop Presentation 12:35 Networking Luncheon in Poster and Exhibit Hall Fit For Purpose Designand Implementation of Single-Use Bioprocessing Plants Thorsten Peuker, Vice President, Integrated Solutions, Sartorius Stedim Biotech Schedule Subject to Change Register Early for Best Savings

8 We Take the Work out of Networking for You... Take a break from sitting in conference sessions and enjoy all these networking activities we have built into the conference schedule for you: Monday March 30 Exhibit and Poster Hall Hours: 9:45-6:45 Refreshment Break: 9:45-10:30 Luncheon: 12:35-1:35 Refreshment Break: 3:15-4:00 BDP Big Top Networking Reception: 5:30-6:45 Tuesday March 31 Exhibit and Poster Hall Hours: 9:45-3:30 Refreshment Break: 9:45-10:30 Luncheon: 12:35-1:35 Refreshment Break: 2:45-3:30 BDP Beach Party: 5:30 Wednesday April 1 Exhibit and Poster Hall Hours: 9:45-6:45 Refreshment Break: 9:45-10:30 Luncheon: 12:35-1:35 Refreshment Break: 3:15-4:00 TBD Networking Reception Thursday April 2 Exhibit and Poster Hall Hours: 9:45-3:30 Refreshment Break: 9:45-10:30 Luncheon: 12:35-1:35 Refreshment Break: 2:45-3:30 Monday, March 30, 2015 (continued) Antibody Drug Conjugate Development & Production 1:40 Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas New Modalities and Next Generation ADCs Challenges in Development and Production 1:45 Development of a Site-Specific Conjugation Process Applicable to Monoclonal and Bispecific Antibodies Ellen O Connor, Ph.D., Senior Scientist, MedImmune 2:15 Producing Homogeneous Site Specific ADCs using Xpress CF+ Aaron Sato, Ph.D., Vice President, Research, Sutro Biopharma Inc. 2:45 Probody Drug Conjugates (PDCs): A Path to Safer and More Effective ADCs Sridhar Viswanathan, Ph.D., Vice President, Process Sciences & Manufacturing, CytomX Therapeutics, Inc. Upstream Processing Chandana Sharma, Ph.D., Principal Scientist, Cell Sciences and Development, SAFC Improving and Controlling Process and Product Quality / Impact of Cell Culture on Critical Quality Attributes Evolution of Cell Culture Validation Studies as a Result of Lessons Learned from Implementing Quality by Design Steve Meier, Ph.D., Principal Engineer and Senior Group Leader, Genentech A Roadmap for Improvement in Control Strategy using Retrospective Quality by Design (QbD) Principles for a Commercial Molecule Anup Agarwal, Ph.D., Senior Upstream Engineer, MS&T, Shire Virus Safety Assurance of Cell Culture Process in Biologics Manufacturing Shengjiang Shawn Liu, Ph.D., Head and Principal Scientist, Pathogen Safety, Bayer HealthCare Pharmaceuticals LLC 3:15 Networking Refreshment Break in Poster and Exhibit Hall New Modalities and Next Generation ADCs Challenges in Development and Production (continued) 4:00 A Versatile, Modular Approach to Building Customized, Site-Specifically Conjugated ADCs using SMARTag Technology Penelope M. Drake, Ph.D., Biology Group Leader, Catalent Biologics West formerly Redwood Bioscience Improving and Controlling Process and Product Quality / Impact of Cell Culture on Critical Quality Attributes (continued) The Production of Antibodies as Single Glycoforms or with a Restricted Glycosylation Profile Michael Butler, Ph.D., Professor of Microbiology, University of Manitoba, Canada Welcome to the BDP Big Top! Monday, March 30 at 5:30 pm Grab your popcorn and peanuts as you make your way through the exhibit hall for your front row look at the most amazing display of biopharmaceutical technologies and services all under the BDP Big Top! 4:30 Clinical Development of ADCs How are We Doing? Robert Lutz, Ph.D., Vice President, Translational Research & Development, ImmunoGen, Inc. 5:00 Controlled Conjugation Strategies and the Preparedness of CMOs and Internal Facilities for New Linker/Payloads and Processing Strategies Moderator: Michael Sun, Ph.D., Seattle Genetics, Inc. Panelists: Olivier Marcq, Ph.D.,, Pfizer Ellen O Connor, Ph.D., MedImmune Aaron Sato, Ph.D., Sutro Biopharma Inc. Ian Schwartz, M.S., Agensys, an affiliate of Astellas Mary Robinette, Sigma Aldrich Tools for Achieving Product Quality Targets During Rapid Early Phase Development Stewart McNaull, Ph.D., Director, Development & Technical Services, FUJIFILM Diosynth Biotechnologies Close of Monday Upstream Processing Track 5:30 BDP Big Top Reception in Poster & Exhibit Hall 8 For up-to-date program information and new abstracts, visit:

9 Monday, March 30, 2015 (continued) NEW Single-Use Applications Analytical Methods 1:40 Christopher J. Smalley, Ph.D., Director of Validation, Compliance, Merck & Co. Single-Use Implementation and Transfer Case-Studies 1:45 Battle of the Sensors: Single Use vs Traditional Probes Edward Chan, Technical Specialist, Cell Culture Pilot Plant, Genentech Technologies John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, NIST Comparability Strategies for Biosimilars and Other Biotechnology Products (continued) The Role of Pharmacopeial Standards in the Context of Biosimilars Tina Morris, Vice President, Biologics & Biotechnology, United States Pharmacopeia Quality and Control Gregory Stromberg, M.B.A., Senior Associate Scientist, Manufacturing Sciences Process Analytics, Biogen Idec Take the Next Steps in Process Validation Innovation Paradigm for Process Validation of Biopharmaceuticals Kim H. Wong, Ph.D., Director, Facilities & cgmp Support, BioProcess Research & Development, Sanofi Pasteur Ltd. 2:15 Single-Use System: Obstacles to Implementations Christopher J. Smalley, Ph.D., Director of Validation Compliance, Merck & Co. 2:45 Implementation of Single-Use Technology for Production of the UK Anthrax Vaccine Kelly Thomas, Senior Project Team Leader, Vaccine Research Group, Public Health England Application of NMR Spectral Fingerprinting for Structure Assessment of Monoclonal Antibody Therapeutics John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, NIST Success and Lessons Learned in Characterization and Comparability Moderator: Parastoo Azadi, Ph.D., University of Georgia Panelists: M. Lorna De Leoz, Ph.D., National Institute of Standards and Technology Camellia Zamiri, Ph.D., Genentech, a Member of the Roche Group John P. Marino, Ph.D., NIST Tina Morris, United States Pharmacopeia 3:15 Networking Refreshment Break in Poster and Exhibit Hall Continued Process Verification in Practice Andrew Lenz, Manager, Global Process Analytics, Biogen Idec Process Analytical Technology: From Theory to Implementation Justin Moretto, Associate Scientist III, Biogen Idec BPSA Roundtable Development of Biosimilars Take the Next Steps in Process Validation Innovation (continued) 4:00 The Road Ahead: Issues Impacting the Accelerated Adoption of Single-Use Technologies Moderator: Kevin Ott, BPSA Executive Director Topics & Speakers: Extractables and Leachables Standardization: Jerry Martin, Pall Corporation Change Order Management: TBA Integrity Testing: TBA Particulates: James D. Vogel, BioProcess Institute BPSA End-User Committee Perspectives: Mark Petrich, Merck & Company, Inc. Challenges in Comparability Studies of Carbohydrate Containing Biosimilars Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia 4:30 Advances and Challenges in the Analytical Characterization of Biosimilar Products Jeff Allen, Ph.D., Director of Protein Sciences, Pfenex Inc 5:00 Close of Monday Analytical Methods Technologies Track Honing the Approach and Embracing New Paradigms Moderator: Kim H. Wong, Ph.D., Sanofi Pasteur Ltd. Panelists: Monica Lent, Genentech Donald Singer, GlaxoSmithKline Kristen Manchester, Bristol-Myers Squibb Andrew Lenz, Biogen Idec Justin Moretto, Biogen Idec Quality Manufacturing Methodologies New Steps to Ensure Successful Product Package Integrity Evaluations Donald Singer, Global Lead Quality Manager, Microbiology, R&D, GlaxoSmithKline Closing the Buffer Gap Methodology to Ensure ph Functionality in Purification Operations Casey Dunn, Process Engineer I, MSAT, Genzyme Corporation 5:30 BDP Big Top Reception in Poster & Exhibit Hall Register Early for Best Savings

10 Antibody Drug Conjugate Development & Production Tuesday, March 31, 2015 Upstream Processing 7:30 Registration and Coffee 8:00 Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. Stuart McNaull, Ph.D., Director, Development and Technical Services, Fujifilm Diosynth Biotechnologies Analytical Characterization for ADCs 8:15 Overcoming Analytical Challenges during Development and Production of ADCs Yan Chen, Ph.D., Technical Development Senior Scientist, Protein Analytical Chemistry, Genentech, Inc. Media Development Optimization Evaluation of Alternatives to Animal Derived Reagents Used for Productivity Enrichment During Cell Line Development Christina Alves, Ph.D., Scientist II, Biogen Idec 8:45 Real-time Monitoring of ADC Conjugation Process Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas Media Development Strategies for Platform and Late Phase Cell Culture Process Wenge Wang, Ph.D., Senior Principal Scientist, Bioprocess R&D, Pfizer 9:15 Process Development Approaches Raw Materials Establishing Supply Chain Transparency Supplier validation Understanding your raw materials Process Development of a Polysaccharide-Protein Control of suppliers Single use systems Conjugate Vaccine using Automated, High Throughput Methodologies Emily Wen. Ph.D., Associate Principal Scientist, Vaccine Process Development, Merck Research Laboratory Viral safety Reducing lot-to-lot variability 9:45 Networking Refreshment Break in Poster and Exhibit Hall 10:25 Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. Stuart McNaull, Ph.D., Director, Development and Technical Services, Fujifilm Diosynth Biotechnologies Single Use Applications in Upstream Processing 10:30 Orthogonal Analytical Characterization in Supporting Process Development Qin Zou, Ph.D., Senior Principal Scientist, Pfizer, Inc. Scale-Up and Tech Transfer of a High Cell Density Perfusion Cell Culture Process Utilizing a CHO Cell Line Rahul Chelikani, Ph.D, Senior Bioengineer, Shire HGT 11:00 Raw Material Variability - Assessing Quality of Polysorbate in the Formulation of ADCs Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. 11:30 A Novel Antibody Drug Conjugation Method Using Ambrx s EuCode Technology and Its Application in Product Development Case Studies of Conjugation Development and Scale-Up for Clinical Manufacturing Yun Bai, Ph.D., Associate Director, Process Development, Ambrx Inc. Upstream Disposable Technology Supports the Implementation of Continuous Processing Shaun P. Eckerle, Principal Scientist, Cell Culture Development, Patheon Biologics Challenges of Cell Culture and Harvest for a High Cell Density Process in Disposables Platform Sigma S. Mostafa, Ph.D., Director, Process Development, KBI Biopharma Technology Workshop Presentation 12:05 New Low Shear Force Single-Use Pump Agile Development of a Biobetter ADC: System Enables High Cell Viabilities, Protein A Case Study! Activities and a Safe, Pulsation Free Conveyance of Sensitive L.C. Liu, CEO & President, EirGenix Biotech Media Molly McGlaughlin, Vice President, Business Development, EirGenix Wolfgang Dornfeld, MSc, BSc, MBA, VP Field Operations, Levitronix GmbH Ina Dittler, MSc, Research Asst, School of Life Sciences & Facility Management, Zurich University of Applied Sciences 12:35 Networking Luncheon in Poster and Exhibit Hall 10 For up-to-date program information and new abstracts, visit:

11 Tuesday, March 31, 2015 NEW Single-Use Applications Analytical Methods Technologies 7:30 Registration and Coffee 8:00 Rahul Chelikani, Ph.D, Senior Bioengineer, Shire HGT Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. Quality and Control Paul Duncan, Ph.D., Senior Principal Scientist, Vaccine, Analytical Development, Merck & Co. Single-Use Considerations for Cell Culture Applications 8:15 Case Study for Rapid Development and Scale-Up of a High Productivity CHO Process for a Novel Anti-HIV mab Bhargavi Kondragunta, Ph.D., Vaccine Production Program, Vaccine Research Center, NIAID, NIH 8:45 Integrating a Fully-Disposable Centrifuge a Completely Disposable Facility (200L Scale) Brad Ebel, Manager, LSDL, Shire 9:15 Single-Use Fermentation Performance and Evaluation Surendra Balekei, Senior Product Manager, Single-Use Reactors and Mixers, Thermo Fisher Scientific Analytical Characterization for ADCs Overcoming Analytical Challenges during Development and Production of ADCs Yan Chen, Ph.D., Technical Development Senior Scientist, Protein Analytical Chemistry, Genentech, Inc. Real-Time Monitoring of ADC Conjugation Process Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas Analytical Development and Characterization Tools(3-D Structure of mab/adcs, Mass Spec) Oscar Salas-Solano, Ph.D., Senior Director of Analytical Sciences, Seattle Genetics, Inc. Viral Safety Mitigation of Viral Risk Associated with Rabbit Polyclonal Antibodies Used During Production Cell Line Generation Dayue Chen, Ph.D., Research Advisor, Process Development, Eli Lilly & Co. Effective Viral Clearance More than High Reduction Factors Horst Ruppach, Ph.D., Senior Director, Viral Clearance, Charles River Biologics Testing Solutions, Germany Comparison Between Infectivity and RT-qPCR Assays of X-MuLV in Virus Clearance Studies Anwar Zaman, Ph.D., Senior Scientist, Bayer Healthcare Pharmaceuticals 9:45 Networking Refreshment Break in Poster and Exhibit Hall 10:25 Rahul Chelikani, Ph.D, Senior Bioengineer, Shire HGT Single Use Applications in Upstream Processing 10:30 Scale-Up and Tech Transfer of a High Cell Density Perfusion Cell Culture Process Utilizing a CHO Cell Line Rahul Chelikani, Ph.D, Senior Bioengineer, Shire HGT 11:00 Upstream Disposable Technology Supports the Implementation of Continuous Processing Shaun P. Eckerle, Principal Scientist, Cell Culture Development, Patheon Biologics 11:30 Challenges of Cell Culture and Harvest for a High Cell Density Process in Disposables Platform Sigma S. Mostafa, Ph.D., Director, Process Development, KBI Biopharma Thomas A. Little, Ph.D., President, Thomas A. Little Consulting QbD/CQA Concepts from Development to Submission Essentials in Quality by Design for Modern Biologics Development Thomas A. Little, Ph.D., President, Thomas A. Little Consulting The Role and Design of Forced Degradation Studies in Biologics Development Xiaoyu Chen, Section Leader, Late Stage Analytics, Merck Successfully Applying QbD Concepts to Develop a Robust Lyophilized Protein Therapeutic Product Kevin Zen Ph.D., Senior Manager, Biologics Development, Allergan Technology Workshop Presentation 12:05 New Low Shear Force Single-Use Pump System Enables High Cell Viabilities, Protein Activities and a Safe, Pulsation Free Conveyance of Sensitive Biotech Media Wolfgang Dornfeld, MSc, BSc, MBA, VP Field Operations, Levitronix GmbH Ina Dittler, MSc, Research Asst, School of Life Sciences & Facility Management, Zurich University of Applied Sciences 12:35 Networking Luncheon in Poster and Exhibit Hall Anwar Zaman, Ph.D., Senior Scientist, Bayer Healthcare Pharmaceuticals Viral Safety (Continued) Application of Regulatory Guidance to New Molecular Detection Methods for Virology and Mycoplasma Barbara Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC UV Irradiation for Efficient Viral Inactivation in the Downstream Process for a Large Protein Therapeutic Tobias O'Neill, Senior Scientist, Downstream Process Development, Patheon Comparison of Two Approaches for Analyzing Next-Generation Sequencing Data for Potential Adventitious and Endogenous Viruses Paul Duncan, Ph.D., Senior Principal Scientist, Vaccine Analytical Development, Merck & Company, Inc. Agile Development of a Biobetter ADC: A Case Study! L.C. Liu, CEO & President, EirGenix Molly McGlaughlin, Vice President, Business Development, EirGenix Schedule Subject to Change Register Early for Best Savings

12 Tuesday, March 31, 2015 (continued) Showcase Your Research Submit a Poster Presentation Consider presenting a poster at this conference to derive more value from attending. Share your research with your peers and learn from other posters as well. Many attendees tell us that being selected for a poster presentation helps to facilitate their company approval process to attend the conference. Submit your poster abstract online today for review at Poster abstract submission deadline: Friday, March 6 Antibody Drug Conjugate Development & Production 1:40 Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc. Formulations and Fill/Finish for ADCs that are More Potent and Less Stable 1:45 ADC Formulation Development Janet Wolfe, Ph.D., President, Wolfe Laboratories 2:15 Conjugation & Fill/Finish: A New Concept Applied to the Supply Chain of ADCs from Earlier Conjugation Development to GMP Commercial Manufacturing Maria Elena Guadagno, Ph.D., Business Director, BSP Pharmaceuticals, Italy Upstream Processing Susan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants, Inc. Novel Approaches to Emerging Modalities and Process Intensification Development of Complex Antibody- Cytokine Fusion Proteins at High Quality by an Integrative Early Development Approach Markus Neubauer, Ph.D., Principal Scientist, Cell Culture Research, Large Molecule Research, Roche Innovation Center, Pharma Research and Early Development (pred), Germany High Octane Fed Batch: Process Intensification Reimagined Rebecca Moore, Ph.D., Senior Scientist, BioProduction, Thermo Fisher Scientific 2:45 Networking Refreshment Break in Poster and Exhibit Hall Scale Up, Facility Fit & Implementing Single-Use Systems for Manufacturing ADCs 3:30 Rapid Scale Up and Facility Fit for a Mammalian Cytokine Developed in E.coli that was Destined to be Part of a Bioconjugate Shuang Chen, Ph.D., Principal Scientist, Pfizer Inc. Approaches to improve Efficiencies and Reduce Timelines from Discovery to Clinic to Commercial Streamlining Early Cell Culture Development to Reduce Time to Proof-of-Concept Studies Daryl Powers, Ph.D., Senior Scientist, Early Cell Culture Development, Sanofi Global Biotherapeutics 4:00 Manufacturing ADCs Utilizing Full-Disposable System Jason Brady, Director, Sales and Business Development, Lonza 4:30 Single-Use Applications for ADCs Mary Robinette, Process Lead, Engineering, Sigma Aldrich Successful Start-up and Process Transfer: Fast and Furious Marion Glenn, M.S., Engineer II, Global Biologics Manufacturing Sciences and Technology (GBMSAT), Genentech, Inc. Presentation TBA Tim Hill, Ph.D., Fujifilm Diosynth BDP Connect The Online Networking Tool 5:00 Close of Day Two 5:30 BDP Beach Party Networking Cocktail Reception Back by Popular Demand! Tuesday, March 31 at 5:30 pm BDP Connect is the official event online partnering tool. All attendees will receive details on how to access starting 8 weeks before the conference. This tool will help you network not only during but before and after the event as well. Co-Sponsored by: and Shimmering views of the Pacific Ocean will be the back drop at this fun, casual networking reception. You ll enjoy beach themed food, drink and music in this unparalleled coastal setting as you network with speakers, attendees and exhibitors. Free for All Registered Attendees RSVP require 12 For up-to-date program information and new abstracts, visit:

13 Tuesday, March 31, 2015 (continued) NEW Single-Use Applications Analytical Methods 1:40 James Dean Vogel, P.E., Director, The BioProcess Institute Technologies Mark Emanuele, Process Engineer, Genzyme Quality and Control Thomas Kreil, Ph.D., Senior Director, Senior Director, Global Pathogen Safety, Baxter BioScience, Austria Production and Regulatory Considerations for Single-Use Aggregation and Subvisible Particle Analysis in Protein Drug Products Overcoming Challenges in Nanofiltration 1:45 Use of Single-Use Bioreactors for the Production of Recombinant Hemagglutinin for Flublok Jamal Meghrous, Senior Scientist, Protein Sciences Corp. Resolution of Heterogeneous Charged Antibody Aggregates via Multimodal Chromatography: a Comparison to Conventional Approaches Rebecca A. Chmielowski, MSD, Biologics Process Development, Process Development and Engineering, Merck State-of-the-Art Approaches to Robust and Effective Nanofiltration Nathan Roth, Ph.D., Director, Pathogen Safety, Global R&D, CSL Behring 2:15 Genentech s Approach to the Regulatory Environment Surrounding Disposables Kellen Mazzarella, Associate Regulatory Program Director, Genentech, a member of the Roche Group Analyzing Subvisible Particles in Protein Drug Products: A Comparison of Dynamic Light Scattering (DLS) and Resonant Mass Measurement (RMM) Jainik Piyushkumar Panchal, Post Doctoral Fellow, Purdue University Nanofiltration and Pressure- / Flow- Variations: How to Address Recently Recognized Uncertainties Thomas Kreil, Ph.D., Senior Director, Senior Director, Global Pathogen Safety, Baxter BioScience, Austria 2:45 Networking Refreshment Break in Poster and Exhibit Hall Overcoming Challenges Associate with Particles and Extractables & Leachables 3:30 E&L Studies as a Risk-Assessment and Qualification Tool for Single-Use Technologies Used in the Manufacture of Biologics Bobbijo V. Redler, Ph.D,, Associate Principal Scientist, ACDS - Specialty Analytical & Informatics, Center for Extractables and Leachables, Merck & Co., Inc. 4:00 Particulate Control Recommendations for Single-Use James Dean Vogel, P.E., Director, The BioProcess Institute Analytical Characterization Methods for Critical Quality Attributes Process Characterization of Vaccine Candidates: Where Do We Start? Eric Chojnicki, Ph.D., Director CMC, Biologics Development, Allergan Platform for Media and Bioreactor Nutrient Analysis Mark Emanuele, Process Engineer, Genzyme Risk Assessments Via High- Temperature Short-Time (HTST) Treatments Practical Considerations in the Design and Operation of an HTST Skid for GMP Manufacturing Bill Ogden, Associate Director, Engineering Services, MedImmune Evaluation of HTST and Virus Filter Treatment for Cell Culture Media Yasuharu Shinoda, Engineer, API Process Development, Chugai Pharmaceutical Co., Ltd., Japan 4:30 E&L Roundtable Moderator: Bobbijo V. Redler, Ph.D, Associate Principal Scientist, ACDS - Specialty Analytical & Informatics, Center for Extractables and Leachables, Merck & Co., Inc. Panelists: Weibing Ding, Biogen Idec James Dean Vogel Michael Ruberto, Ph.D., President, Material Needs Consulting, LLC Featured Presentation Engineering Novel Proteins and Protein Assemblies as Innovative Therapeutics, Vaccines, and Drug Delivery Vehicles James R. Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University 5:00 Close of Day Two 5:30 BDP Beach Party Networking Cocktail Reception Back by Popular Demand! Tuesday, March 31 at 5:30 pm A Mathematical Model: Predict How HTST Impacts Media Treatment and Resolve Scale-Up Issues Gaurav Chauhan, M.S., Associate Scientist II, Cell Culture and Fermentation Sciences, MedImmune Co-Sponsored by: and Shimmering views of the Pacific Ocean will be the back drop at this fun, casual networking reception. You ll enjoy beach themed food, drink and music in this unparalleled coastal setting as you network with speakers, attendees and exhibitors. Free for All Registered Attendees RSVP require Register Early for Best Savings

14 Track Spotlight Downstream Processing Wednesday, April 1, 2015 Manufacturing Efficiencies: Strategy & Technology 7:30 Registration and Coffee Downstream Processing Stay abreast of the latest innovations occurring in downstream processing to help you optimize efficiencies during harvest and purification of high cell density processes, continuous platforms and emerging modalities. This track will equip you with a deeper understanding of the bottlenecks and emerging purification challenges and provide solutions through the integration of disruptive technologies and methodologies. Manufacturing Efficiencies Developed for decision makers who are involved with shaping the strategic outlook for manufacturing capacity in this industry. From implementing continuous processing to determining whether to build conventional or single-use facilities, this track provide solutions to the emerging challenges related to capacity, process intensification, tech transfers, supply chain, and technological innovations to help you achieve and maintain operational excellence in your biomanufacturing facility of the future. Flexible Facilities Get a comprehensive look at the flexible, multiproduct centric, biomanufacturing landscape from senior level executives and scientists from biopharmaceutical firms, CMOs, technology providers, engineering firms and regulatory groups. Explore the evolving biomanufacturing landscape and beyond through shared case studies on flexible facility implementations, lessons learned and practical experience. BiSpecific Hear the latest progress in molecule design for better solubility, stability, manufacturability and half-life of bispecific antibodies. Innovative companies will share approaches on utilizing new tools and platforms to help you overcome the unique development and production challenges related to this transformative class of therapeutics. Manufacturing Monitoring and Control Understand the requirements of the Drug Supply Chain Security Act, mitigate risks of microbial and adventitious agent contamination, avoid pitfalls for environmental qualification, choose the right cleanroom filters and get a start-up s POV on early stage controls without the bells and whistles. Keynote Presentations 8:00 Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland 8:15 Manufacturing in a Global Market Place TH Kim, Ph.D., President and CEO, Samsung BioLogics 9:00 Innovation in Biologics Manufacturing Hitto Kaufmann, Ph.D., Vice President, Technology and Innovation, Sanofi Biologics, Germany 9:45 Networking Refreshment Break in Poster and Exhibit Hall 10:25 Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland Advances at Harvest Step 10:30 Ultra Scale-Down Characterization Of Bioprocessing Materials for the Early Prediction of the Impacts of Industrial Scale Continuous Centrifugation on the Recovery and Purification of New Therapeutic Candidates Alex Chatel, Ph.D., Bioprocess Enterprise Fellow, Biochemical Engineering, University College London, United Kingdom 11:00 How To Improve Harvest Step Yields Jean Bender, M.S., Senior Director, MedImmune 11:30 Overcoming Reduction of Antibodies in Harvest Step Michael Laird, Senior Scientist, Associate Director, Process Development, Genentech, Inc. 12:05 Downstream Processing and New Technology for Continuous Chromatography Maria Ekblom, Senior Project Manager, Chromatography Systems, GE Healthcare Sid Advant, Ph.D., President, Biologics Division, Kemwell Biopharma Strategies for Supply Chain Management, Facility Fit and Biomanufacturing Capacity Supplier Management Best Practices Patricia Turney, MBA, Executive Director, Medical Device & GMP Materials Supply Chain, Amgen The Potential Impact of Biosimilars on Biomanufacturing Capacity Thomas C. Ransohoff, Vice President & Principal Consultant, BioProcess Technology Consultants, Inc. Facility Fit Challenge Case Studies for Biologics Manufacturing at Boehringer Ingelheim Nuno Fontes, Ph.D., Executive Director, Head of Process Science, Boehringer Ingelheim Concurrent Technology Workshop Presentations Capture Chromatography: Alternatives for Downstream Process Development Shelly Parra, M.S., Sr. Field Application Scientist, Thermo Fisher Scientific How to Rapidly Enable Flexible Biomanufacturing at the Site of Your Choice Vikas Gupta, Modality Leader, Bioprocess Solutions, GE Healthcare Life Sciences (invited) 12:35 Networking Luncheon in Poster and Exhibit Hall 14 For up-to-date program information and new abstracts, visit:

15 Wednesday, April 1, 2015 NEW Flexible FacilitiesAnalytical Methods Technologies 7:30 Registration and Coffee NEW Bispecific Antibody & Production 8:00 Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland 8:15 Manufacturing in a Global Market Place TH Kim, Ph.D., President and CEO, Samsung BioLogics Keynote Presentations 9:00 Innovation in Biologics Manufacturing Hitto Kaufmann, Ph.D., Vice President, Technology and Innovation, Sanofi Biologics, Germany 9:45 Networking Refreshment Break in Poster and Exhibit Hall 10:25 Mark J. Federspiel, Ph.D., Director, Viral Vector Production Laboratory, Mayo Clinic Comprehensive Cancer Center Fengqiang Wang, Ph.D., Principal Scientist, Sterile Product and Analytical Development, Merck Kenneth Kang, Ph.D., Principal Scientist, Head of Purification R&D, BioProcess Sciences, Eli Lilly and Company Non-Classified, Closed and Other Considerations and for Single-Use Implementation 10:30 Pushing the Controlled Non-Classified (CNC) Envelope With the Application of Single-Use Systems for Bioprocessing Kenneth Green, Ph.D., Head of Manufacturing Science and Technology, Shire Quantitation and Control Strategies for HCPs Antigen Excess and Avoiding HCP Quantitation Errors Sara Parker, Ph.D. Senior Manager Analytical Operations, Genentech, a Member of the Roche Group, Inc. Molecule Design and Development Strategies to Improve Solubility, Stability, Manufacturability, Half-Life of Bispecific Antibodies Designing Bi and Multi Specific Biologics with Desired Safety/Efficacy Profiles Tariq Ghayur, Ph.D., Distinguished Research Fellow, DVD-Ig & Multi-specific Biologics, Global Biologics, AbbVie 11:00 Flexible and Multiproduct Facility: Single Use Technologies & Biocontainment Strategy Jin Wang, Ph.D., Director, VDL2 Launch Manufacturing Facility, Industrial Operations, Sanofi Pasteur 11:30 Manufacturing a Recombinant Measles Virus For Treating Patients With Multiple Myeloma Mark J. Federspiel, Ph.D., Director, Viral Vector Production Laboratory, Mayo Clinic Comprehensive Cancer Center 12:05 Downstream Processing and New Technology for Continuous Chromatography Maria Ekblom, Senior Project Manager, Chromatography Systems, GE Healthcare Analytical Challenges and Solutions for In-House HCPs Assay Development, Case Studies from HCPs Antigen Selection to Anti-HCPs Reagents Qualification Fengqiang Wang, Ph.D., Principal Scientist, Sterile Product and Analytical Development, Merck Comparing a New Methacrylate Protein A Resin with Agarose Protein A-Focus on Host Cell Protein Clearance Edward Koepf, Ph.D., Process Development Scientist, Biogen Idec Concurrent Technology Workshop Presentations How to Rapidly Enable Flexible Biomanufacturing at the Site of Your Choice Vikas Gupta, Modality Leader, Bioprocess Solutions, GE Healthcare Life Sciences (invited) Modular Development of mab2 Bispecific Antibody Drug Candidates in Oncology Kate Seaber, MBA, Executive Programme Director, F-Star Azymetric Antibody Design: Impact on Developability of Bispecific Therapeutics Surjit Dixit, Ph.D., Chief Technology Officer, Zymeworks Inc. Capture Chromatography: Alternatives for Downstream Process Development Shelly Parra, M.S., Sr. Field Application Scientist, Thermo Fisher Scientific 12:35 Networking Luncheon in Poster and Exhibit Hall Schedule Subject to Change Register Early for Best Savings

16 Get the Complete BDP Experience Wednesday, April 1, 2015 (continued) Downstream Processing 1:40 Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems Manufacturing Efficiencies: Strategy & Technology Continuous Processing 1:45 Continuous Chromatography: The Good, the Bad, and the Unexpected Oliver Kaltenbrunner, Ph.D., Scientific Director, Chemical Process R&D, Amgen All Access Pass Get the complete BDP Week experience when you register for the BDP Week All Access Pass. This pass offers you the best value and access to everything the event has to offer. 2:15 How to Optimize the Perfusion Rate in High Cell Density Perfusion of Chinese Hamster Ovary Cells Culture in Stirred Tank Veronique Chotteau, Ph.D., Prinicpal Investigator, Researcher, Cell Technology Group, School of Biotechnology, KTH, Royal Institute of Technology, Sweden 2:45 Integrated and Fully Continuous Processing of Recombinant Therapeutic Proteins From Cell Culture Media to Purified Drug Substance Veena Warikoo, Ph.D., Director, Purification Development, Genzyme 3:15 Networking Refreshment Break in Poster and Exhibit Hall Continuous Processing (continued) 4:00 Exploring Options for Achieving Diafiltration in a Continuous Process Alex Brinkmann, Engineer III, Biogen Idec International Food Festival Join us in the exhibit hall as you take a culinary trip around the world, sampling beers paired with foods from countries around the globe, near and far. Sponsored by: 4:30 ASAP (Automated Seamless Antibodies Purification): Toward a Fully-Disposable Process Benoit Mothes, Pharm D, Senior DSP Scientist, Sanofi, France 5:00 Continuous Downstream Processing: Where Does It Fit? Sponsored by: Continuous downstream bioprocessing seems a natural fit with perfusion technology. Yet, in large scale industrial biotechnology, hybrid processes consisting of fed-batch upstream and continuous downstream are common. Can biomanufacturing benefit from hybrid approaches? Is this a case-by-case decision or are there guidelines and principles that can guide us? The panelists in this discussion will include representatives from companies working on fed-batch/continuous downstream approaches, Perfusion/continuous downstream approaches, a supplier to the industry and a regulatory/ CMC consultant. Moderator: Marc Bisschops, Ph.D., Scientific Director, Tarpon Biosystems 5:30 International Food Festival Networking Reception in Poster and Exhibit Hall Sponsored by: 16 For up-to-date program information and new abstracts, visit:

17 Wednesday, April 1, 2015 (continued) NEW Flexible FacilitiesAnalytical Methods 1:40 Kenneth Green, Ph.D., Head of Manufacturing Science and Technology, Shire Process and Facility Design Strategies and Considerations 1:45 Processes of the Future : Single Use, Closed and Continuous for Faster, Cheaper and Safer Manufacturing Sébastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, EMD Millipore 2:15 Single-Use Bioreactors for Commercial Production of Antibodies Matt Croughan, Ph.D., Industry Professor and Founder of Bioprocessing Program, Amgen Bioprocessing Center at Keck Graduate Institute 2:45 Conventional vs. Single-Use Facilities Moderator: Adam Goldstein, Genentech Panelists: Nuno Fontes, BI Jodi Zobrist, Gallus Biopharmaceuticals Chris Antoniou, Biogen Idec Chris Brodeur, BioMarin Ekta Mahajan, Genentech Technologies Vladimir Razinkov, Principal Scientist, Process & Product Development, Amgen, Inc. Quantitation and Control Strategies for HCPs Novel Impurity Challenge Study in mab AEX Polishing Step Bo Qi, M.S., Director, Process Development Downstream, Eli Lilly and Company Chromatography Considerations to Combat HCPs Membrane Filtration Can Substitute Chromatography Purification Steps for Plant-Derived and ELP-Tagged Biopharmaceutical Proteins Johannes Felix Buyel, M. Sc., Institute for Molecular Biotechnology, RWTH Aachen University/ Integrated Production Platforms, Fraunhofer IME, Germany High-Throughput Methods and Strategies Multidimensional Analysis of mab Formulations by High Throughput Methods Vladimir Razinkov, Principal Scientist, Process & Product Development, Amgen, Inc. 3:15 Networking Refreshment Break in Poster and Exhibit Hall NEW Bispecific Antibody & Production Sid Advant, Ph.D., President, Biologics Division, Kemwell Biopharma Development of Generic or Platform Production Process Challenges and Solutions Production and Purification of Bispecific Antibodies using Duobody Technology Rick Hibbert, Ph.D., Scientist, Protein Separation, Genmab, The Netherlands Harmonizing Processes for Bispecific Protein Development Amit Mehta, Ph.D., Senior Engineer, Group Leader, Genentech, Inc. Innovative Solutions for the Expression of Bispecifics Pierre Moretti, Head, Cell Line Development, Glenmark (Invited) Process Development and Manufacturing Strategies 4:00 Implementation Strategies and Challenges for Single-Use in a Large Company Setting Adam Goldstein, Senior Manager Clinical Operations, Genentech 4:30 Strategies for Implementing Single-Use Technologies in Biopharmaceutical Manufacturing Ying Gao, Ph.D., Process Analytical & Development Group, Development & Production, Public Health England 5:00 Case Study of 12 Flexible Facility Biopharm Projects: Emerging trends in Flexibility for Strategic Advantage Niels Guldager, Senior Technology Partner, NNE Pharmaplan High-Throughput Methods and Strategies (continued) High Throughput Determination of IgG Titer in Cell Culture via Affinity Chromatography Kevin Lin, Research Associate, Genentech, a Member of the Roche Group Assays of Higher Throughput for Efficient Measurement of Drug Potency and Impurity Wei Zhang, Ph.D., Principal Scientist, Analytical Development, Biogen Idec In-Line Separation by Capillary Electrophoresis Prior to Analysis by Top-Down Mass Spectrometry Enables Sensitive Characterization of Protein Complexes Xuemei Han, Ph.D., Research Associate, The Scripps Research Institute 5:30 International Food Festival Networking Reception in Poster and Exhibit Hall Sponsored by: Development of Generic or Platform Production Process Challenges and Solutions (continued) Build Up a Toolbox for Bispecific Antibody Downstream Processing Kenneth Kang, Ph.D., Principal Scientist, Head of Purification R&D, BioProcess Sciences, Eli Lilly and Company Purification of a Dual Affinity Diabody Gregory A. Waszak, M.S., Principal Scientist, Purification Process Development, Pfizer Inc. Bispecific Antibody Platform - Challenges and Solutions Moderator: Kenneth Kang, Ph.D., Principal Scientist, Head of Purification R&D, BioProcess Sciences, Eli Lilly and Company Panelists: Rick Hibbert, Ph.D., Scientist, Protein Separation, Genmab, The Netherlands Amit Mehta, Ph.D., Senior Engineer, Group Leader, Genentech, Inc. Schedule Subject to Change Register Early for Best Savings

18 Let's Get Social Join IBC Life Sciences 11,000 member LinkedIn group: Bioprocessing Professionals. With more than 8,000 members, you have the opportunity to post questions and find networking contacts. Get involved today. Like IBC Life Sciences on Facebook and you will stay up to date with newly added speakers, conference discounts and more. Follow Us on Twitter for special offers and news about the event. Use the #bdpweek hashtag to discuss the event. Stay up to date with IBC Life Sciences and follow us Downstream Processing Thursday, April 2, :30 Registration and Coffee 8:00 Nathalie Frau, Ph.D., Founder & Principal Consultant, NPOS BioConsult 8:15 8:45 The Nokia Syndrome: Could Protein A Be Next? Pete Gagnon, M.S., Group Manager, Downstream Processing, Bioprocessing Technology Institute, Singapore Integrating Disposables (Clinical and Commercial) in Downstream Processing Single-Use Chromatography Platform For Monoclonal Antibody Purification Renaud Jacquemart, Ph.D., Senior Scientist, Process Sciences, Natrix Separations 9:15 Disposable Membrane Chromatography Systems as a Platform for mab Purification Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon Manufacturing Efficiencies: Strategy & Technology Thomas C. Ransohoff, Vice President & Principal Consultant, BioProcess Technology Consultants, Inc. Process Portability and Technology Transfer Manufacturing for Global Markets (8:05) Genentech, CMO s Partnerships for Success David Cate, Principal Manufacturing Technical Specialist, Genentech (8:30) 20 Years of Successful Transfers into Lonza Portsmouth Early Adoption of Best Practices Leads to Long Term Success Rajesh G. Beri, Ph. D., Head, Mammalian Research & Technology, Lonza (8:55) Meeting Diverse Technology Transfer Expectations A CMO Perspectives Jaby Jacob, Ph.D., Assistant Vice President, Process Development, Kemwell Pharma, India (9:20) Development, Scale-Up and Process Validation of Anthim : A Case Study in Effective CMO Management & Collaboration Colin Campbell, Associate Director, Process Development, Elusys Therapeutics, Inc. 9:45 Networking Refreshment Break in Poster and Exhibit Hall Approaches to Improve Efficiencies and Reduce Timelines 10:30 Development of a Streamlined and Cost-effective Downstream Process for Broadly Neutralizing Monclonal Antibody for HIV From Bench to Clinical Manufacturing Xun Liu, Ph.D., Staff Scientist, Vaccine Production Program Laboratory, Vaccine Research Center, National Institutes of Health 11:00 Innovation to Column Chromatography: Streamlining the Elution Pool Collection; Save Time, Save Space, Maintain Quality Robert Gronke, Ph.D., Senior Principal Scientist, Biogen Idec 11:30 The Need for Speed Leveraging High Throughput Technology to Accelerate the Time to Clinic Edward K. Koepf, Process Development Scientist, Process Biochemistry, Biogen Idec BPOG Session Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom Raw Material Variability: The Need for Supply Chain Collaboration, Transparency and Mutually Beneficial Relationships A BPOG team member (TBD) Technology Workshop Presentation 12:05 Establishing Biotech Manufacturing Capacity in China Kang Wei, NNE Pharmaplan Point-Counterpoint Discussion: Aligning End User Needs and Supplier Capabilities; Process Technology, Consumables and Raw Materials Moderator: Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom 12:35 Networking Luncheon in Poster and Exhibit Hall 18 For up-to-date program information and new abstracts, visit:

19 Thursday, April 2, 2015 NEW Flexible FacilitiesAnalytical Methods Technologies 7:30 Registration and Coffee 8:00 Heidi J. Hoffmann, Ph.D., Senior Director, Manufacturing, Sutro Biopharma Arvind Srivastava, Ph.D., Director, Formulation Development, Eli Lilly & Co. Manufacturing Monitoring and Control Bill Fletcher, Managing Director, Pharma Logic Solutions, LLC Design, Management and Implementation Considerations for Flexible Facilities 8:15 Managing Multi-Use Pilot Facilities Katerina Sarkovski, Operational Manager, Clinical Bulk Manufacturing (CBM), Sanofi Pasteur: Bioprocess Research and Development (BRD) Aggregation and Subvisible Particle Characterization and Control Characterization of Aggregates in Blood- Derived Products and Their Recombinant Analogs Lokesh Bhattacharyya, Lab Chief, LACBRP/DBSQC, FDA/CBER/OCBQ (Invited) Managing Supply Chain Quality & Control Understanding the Requirements of Drug Supply Chain Security Act (DSCSA) Bill Fletcher, Managing Director, Pharma Logic Solutions, LLC 8:45 Design and Implementation of a cgmp Manufacturing Facility Biologics Production Heidi J. Hoffmann, Ph.D., Senior Director, Manufacturing, Sutro Biopharma Probing Structurally-Altered and Aggregated States of Therapeutically Relevant Proteins Using GroEL Coupled to Bio-Layer Interferometry Mark Fisher Ph.D., Professor, Department of Biochemistry and Molecular Biology, Robert E. Hemenway Life Sciences Innovation Center, University of Kansas Medical Center 9:15 Late-Breaking Presentation Monitoring and Control of Particulates in Protein Therapeutics Arvind Srivastava, Ph.D., Director, Formulation Development, Eli Lilly & Co. Identification of Chemically Defined Dry Powder Cell Culture Media and Feeds with Raman Spectroscopy: Sensitivity Limitations and Polymorphism Kevin Kent, Ph.D., Senior Scientist, SAFC 9:45 Networking Refreshment Break in Poster and Exhibit Hall BPOG Session 10:30 Capacity, Technology and Innovation Trends in a High Variety Product Portfolio World Simon Chalk, Director, BioPhorum Operations Group (BPOG), United Kingdom Aggregation and Subvisible Particle and Control (continued) Analysis of Maytanisnoid ADCs by Imaged Capillary Isoelectric Focusing (icief) Joyce Lin, MSc., Pr. Analytical Associate, Analytical and Pharmaceutical Sciences, ImmunoGen Inc. Inspection, Enforcement and Evolving Biological Standards Trends Consensus Standards Streamlining Manufacturing Christine DeJong, Technical Committee Operations Manager, ASTM International 11:00 Raw Material Variability: The Need for Supply Chain Collaboration, Transparency and Mutually Beneficial Relationships A BPOG team member (TBD) Characterization of Potential Degradants in a 20 kda PEGylating Raw Material by Orthogonal Analytical Techniques (RP- HPLC, APCI-MS and NMR) Ying Luo, Process and Product Development, Amgen, Inc. Managing the Risks of Leachables from Manufacturing Equipment A Blueprint for Success Michael A. Ruberto, Ph.D., President, Material Needs Consulting, LLC 11:30 The Evaluation of Disposable Column Components and Disposable Columns in Place of Traditional Stainless Steel Chromatography Column Equipment Used in Large Scale Bio-Processing Shaun Grier, Process Development, Shire Regulatory Pathways for Licensure of Pandemic Influenza Vaccines: FDA Approach David S. Cho, Ph.D., Senior Scientist for Emerging & Pandemic Threat Preparedness, CBER, U.S. FDA Technology Workshop Presentation 12:05 Establishing Biotech Manufacturing Capacity in China Kang Wei, NNE Pharmaplan Risk Mitigation of Adventitious Agent Contamination: Equipment and Facility Cleaning Validation Studies Jeri Ann Boose, Director of Biopharmaceutical Services, Eurofins Lancaster Laboratories 12:35 Networking Luncheon in Poster and Exhibit Hall Schedule Subject to Change Register Early for Best Savings

20 Thursday, April 2, 2015 (continued) Downstream Processing 1:40 Nathalie Frau, Ph.D., Founder & Principal Consultant, NPOS BioConsult Automated and High Throughput Process Development Manufacturing Efficiencies: Strategy & Technology Phil McDuff, Sr. Director, Engineering, Biogen Idec Biomanufacturing of the Future Exciting Case Studies From These Leading Industry Companies: AbbVie Agensys Allergan Ambrx Amgen Biogen Idec BSP Pharmaceuticals Charles River Biologics Testing Solutions CSL Behring CytomX Therapeutics Eli Lilly and Company Elusys Therapeutics Genentech GlaxoSmithKline ImmunoGen KBI Biopharma MannKind MedImmune Merck NIH NNE Pharmaplan Pfizer Pharmacopeia Public Health England Purdue University Roche Innovation Center Sanofi Global Biotherapeutics Sanofi Pasteur Seattle Genetics Shire HGT Sutro Biopharma Swiss Federal Institute of Technology The Scripps Research Institute Zymeworks 1:45 Robo-Characterization: Can HTS Miniature Columns Predict a Manufacturing Future? Jennifer Pollard, M.S., Principal Scientist, Merck & Co BARDA Core Services Enhancing Vaccine Development and Manufacturing R. Thomas Warf, Director, Manufacturing, Facilities, and Engineering, BARDA, U.S. Department of Health and Human Services (Invited) 2:15 High Throughput Process Development & Characterization Using Multiple Scale-Down Platforms Alex Berrill, M.S., Ph.D., Principal Scientist, Purification Process Development, Pfizer Change in Biomanufacturing is a Good Thing: Nothing to be Scared of, a Lot to be Gained Sadettin S. Ozturk, Ph.D., Assoc. Deputy Director, Process and Analytical Development, MassBiologics of the University of Massachusetts Medical School 2:45 Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing Advances in Modeling and Characterization to Better Predict, Understand and Control Downstream Processes 3:30 Rational Downstream Development Based on Computational Biophysics Francis Kobina Insaidoo, Ph.D., Ph.D., MRL Postdoctoral Fellow, Process Development and Engineering, Merck Research Laboratories 4:00 Downstream Process Characterization Studies to Support Process Validation Runs for Cyramza, a Recently Approved Monoclonal Antibody Richard Chin, Associate Vice President, Process Development Downstream, Eli Lilly and Company 4:30 Implementation of Definitive Screening Design for Statistical Analyses and Assignment of Criticality for Downstream Process Parameters Michael Clark, Ph.D., Senior Scientist, Process Sciences, AbbVie 5:00 Close of BDP Week SESSION HIGHLIGHTS Keynote or Featured Presentation Case Study Biomanufacturing of the Future Approach to Rapid Global Deployment with Modular Facilities for Filling and Bulk Biologics Marc Devlaminck, Associate Director Engineering, Architect, Merck The Application of Closed Systems to Increase Flexibility and Multiproduct Utilization of Facilities Phil McDuff, Sr. Director, Engineering, Biogen Idec Defining Flexible and Multiuse Facilities Alain Pralong, Vice President New Production Introduction & Life Cycle, GSK Biologicals New Data Panel Discussion 20 For up-to-date program information and new abstracts, visit: