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Thebioprocessingsummit COVER EVENT AT A GLANCE PLENARY KEYNOTE SESSION Eighth Annual SHORT COURSES TRAINING SEMINARS THE SUMMIT UPSTREAM PROCESSING BIOPROCESSING Optimizing Cell Culture Technology Bioproduction: Scale, Bioreactors Practical Solutions for Today’s Bioprocess Challenges & Disposables Optimizing Cell Line Development DOWNSTREAM PROCESSING Continuous Processing in August 15-19, 2016 | Westin Boston Waterfront , Boston, MA Biopharm Manufacturing Advances in Purification Technologies Virus & Pathogen Clearance & Safety in Biologics Preparing for Next-Generation ANALYTICAL & QUALITY Host Cell Proteins: Detection, Products: Emerging Technologies Analysis & Removal Early Analytical Development for Biotherapeutics & Innovative Strategies Process Characterization, Qualification & Control FORMULATION & STABILITY Rapid Methods to Assess Quality & Stability of Biologics Overcoming Formulation Challenges High-Concentration Protein Formulations CELL & GENE THERAPY PRODUCTION Cell Therapy CMC, Quality & Analytics Cell Therapy Bioproduction, Operations & Logistics Gene Therapy Bioproduction Manufacturing & CMC Strategies for Biologics SPONSORS & EXHIBITORS BioprocessingSummit.com HOTEL & TRAVEL REGISTRATION INFORMATION Premier Sponsors BioprocessingSummit.com Cambridge Healthtech Institute COVER EVENT AT A GLANCE Event at a Glance PLENARY KEYNOTE SESSION EVENT AT A GLANCE SHORT COURSES TRAINING SEMINARS Monday - Tuesday Wednesday - Thursday AM Thursday PM - Friday August 15 - 16 August 17 - 18 August 18 - 19 UPSTREAM PROCESSING STREAM #1 Optimizing Cell Culture Technology Optimizing Cell Culture Bioproduction: Scale, Bioreactors Optimizing Cell Line Technology & Disposables Development Bioproduction: Scale, Bioreactors Upstream Processing & Disposables STREAM #2 Continuous Processing in Advances in Purification Virus & Pathogen Clearance Optimizing Cell Line Development Downstream Processing Biopharm Manufacturing Technologies & Safety in Biologics DOWNSTREAM PROCESSING Continuous Processing in STREAM #3 Host Cell Proteins: Detection, Early Analytical Development for Process Characterization, Biopharm Manufacturing Qualification & Control Analytical & Quality Analysis & Removal Biotherapeutics Advances in Purification Technologies STREAM #4 Rapid Methods to Assess Overcoming Formulation High-Concentration Virus & Pathogen Clearance Formulation & Stability Quality & Stability of Biologics Challenges Protein Formulations & Safety in Biologics STREAM #5 ANALYTICAL & QUALITY Cell Therapy CMC, Cell Therapy Bioproduction, Gene Therapy Bioproduction Cell & Gene Quality & Analytics Operations & Logistics Host Cell Proteins: Detection, Therapy Production Analysis & Removal Manufacturing & CMC Early Analytical Development for Strategies for Biologics Biotherapeutics Introduction to Bioprocessing Current & Emerging Global Regulatory Introduction to Analytical Method Process Characterization, Expectations for Analytical Elements of Development & Validation for Qualification & Control Introduction to Extractables Biotechnology/Biosimilar Products Therapeutic Proteins & Leachables & Packaging Introduction to Cell Culture Introduction to Downstream FORMULATION & STABILITY Identifying & Managing Risk during Processing Rapid Methods to Assess Development, Scale-Up, & Validation of Biological Processes Quality & Stability of Biologics Overcoming Formulation Cambridge Healthtech Challenges SHORT COURSES DINNER SHORT COURSES DINNER SHORT COURSES Monday, August 15 Tuesday, August 16 Thursday, August 18 High-Concentration Protein Formulations CELL & GENE THERAPY PRODUCTION Cell Therapy CMC, Quality & Analytics ABOUT THE SUMMIT Cell Therapy Bioproduction, Operations & Logistics The Bioprocessing Summit convenes more than 1,000 international bioprocess professionals to share practical solutions for today's bioprocess Gene Therapy Bioproduction challenges. Now in its eighth year, the event features 16 distinct meetings ranging from cell line development and ensuring quality, to formulation, analytical development, continuous processing, purification, viral clearance and safety, and bioproduction. New programming in Manufacturing & CMC Strategies for Biologics 2016 will continue to expand the scope of the event and includes weeklong programming on cell and gene therapy production, and a meeting on manufacturing and CMC strategies for biologics. Along with the impressive array of conferences, the Summit also includes Short Courses SPONSORS & EXHIBITORS and Training Seminars that provide in-depth coverage of critical bioprocess topics. HOTEL & TRAVEL REGISTRATION INFORMATION Give yourself a Bioprocess Holiday this summer! Stimulate and enrich yourself at the 8th Annual The Bioprocessing Summit—the leading bioprocess event! BioprocessingSummit.com ◄ 2 ► COVER EVENT AT A GLANCE PLENARY KEYNOTE SESSION PLENARY KEYNOTE SESSION Wednesday, August 17 SHORT COURSES Preparing for Next-Generation Products: Emerging Technologies & Innovative Strategies TRAINING SEMINARS UPSTREAM PROCESSING Optimizing Cell Culture Technology 4:45 Chairperson’s Remarks portfolio, directing the development of innovative manufacturing platforms and process improvements for clinical and commercial Bioproduction: Scale, Bioreactors John Sterling, Editor-in-Chief, Genetic projects. Morrey holds a B.S. from Indiana University and a Ph.D. & Disposables Engineering & Biotechnology News (GEN) from Stanford University. Prior to BMS, Morrey’s career has Optimizing Cell Line Development included various management roles at Eli Lilly and Company, Cook DOWNSTREAM PROCESSING Pharmica and Targeted Genetics Corporation. Continuous Processing in 5:25 Next-Generation Processes, Technologies and Biopharm Manufacturing 4:50 Challenges Associated With Biomanufacturing Operations Advances in Purification of Evolving Portfolios Technologies Craig Beasley, Vice President, Next Generation Morrey Atkinson, Ph.D., Vice President, Process Manufacturing, Biogen Virus & Pathogen Clearance Sciences, Bristol-Myers Squibb A critical step in meeting the demand of biologic & Safety in Biologics The accelerating pace of biological production worldwide involves implementing ANALYTICAL & QUALITY product development and high rate of disruptive manufacturing technologies, Host Cell Proteins: Detection, technology advancement is causing shifts processes and capabilities. This talk will evaluate Biogen’s Analysis & Removal in biomanufacturing. As an industry, we are new manufacturing site in Switzerland, due to go online in Early Analytical Development for being compelled to match this change with increased 2019, including the new processes, operational models and Biotherapeutics flexibility. From clinical supplies to late life-cycle commercial technologies being adopted to drive value through innovation Process Characterization, production, demand for innovation and creativity has never and deliver new medicines in areas such as Alzheimer’s. Qualification & Control been greater, particularly to reliably supply transformational 6:00 Networking Reception in the Exhibit Hall with FORMULATION & STABILITY medicines such as the new immuno-oncology products. Poster Viewing Rapid Methods to Assess E. Morrey Atkinson, Ph.D., is currently the Vice President of Quality & Stability of Biologics Biologics Development at Bristol-Myers Squibb Company. Morrey Overcoming Formulation is responsible for leading a team of scientists and engineers across CONNECT WITH US Challenges five sites that is responsible for process development, analytical sciences, and manufacturing support for the company’s biologics High-Concentration #BPSMT Protein Formulations CELL & GENE THERAPY PRODUCTION Cell Therapy CMC, Quality & Analytics Present a Poster & Save Cell Therapy Bioproduction, Operations & Logistics Cambridge Healthtech Institute encourages attendees to gain further exposure Gene Therapy Bioproduction by presenting their work in the poster sessions. To secure a poster board and Manufacturing & CMC inclusion in the conference materials, your abstract must be submitted, approved Strategies for Biologics and your registration paid in full by July 15, 2016. SPONSORS & EXHIBITORS • Your research will be seen by leaders • Your poster abstract will be published HOTEL & TRAVEL from top pharmaceutical, biotech, in the conference materials #BPSMT REGISTRATION INFORMATION academic and government institutes • Receive $50 off your registration fee BioprocessingSummit.com ◄ 3 ► COVER EVENT AT A GLANCE PLENARY KEYNOTE SESSION PREMIER SPONSOR SHORT COURSES TRAINING SEMINARS UPSTREAM PROCESSING Optimizing Cell Culture Technology Bioproduction: Scale, Bioreactors & Disposables Optimizing Cell Line Development DOWNSTREAM PROCESSING Continuous Processing in Biopharm Manufacturing Advances in Purification CORPORATE SPONSORS Technologies Virus & Pathogen Clearance & Safety in Biologics ANALYTICAL & QUALITY Host Cell Proteins: Detection, Analysis & Removal Early Analytical Development for Biotherapeutics Process Characterization, Qualification & Control FORMULATION & STABILITY Rapid Methods to Assess Quality & Stability of Biologics Overcoming Formulation Challenges High-Concentration Protein Formulations CELL & GENE THERAPY PRODUCTION Cell Therapy CMC, Quality & Analytics Cell Therapy Bioproduction, Operations & Logistics CORPORATE SUPPORT SPONSORS Gene Therapy Bioproduction Manufacturing & CMC Strategies for Biologics SPONSORS & EXHIBITORS HOTEL & TRAVEL REGISTRATION INFORMATION BioprocessingSummit.com ◄ 4 ► COVER EVENT
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