PREP 2016 Preliminary Scientific Program Click Here to Submit Poster Abstracts (program as of )

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1 PREP 2016 Preliminary Scientific Program Click Here to Submit Poster Abstracts (program as of ) Training Workshop and Tutorial Program The Training Workshop and Tutorial Program provides advanced tutorials covering various aspects of preparative and process chromatography. Workshops and Tutorial are open to conference and nonconference participants. See details and pricing posted online under "Workshops & Tutorial" at PREPsymposium.org. Must pre-register to attend. Sunday, July 17 9:00am-12:30pm 12:30pm-4:00pm 4:00pm-6:30pm Monday, July 18 7:00am-8:30am Workshops (See registration form for cost) Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Processes Focus on biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes. Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC Focus on small molecule pharmaceuticals, APIs, chiral molecules, peptides, oligonucleotides, HPLC, column packing, gradient elution, overloaded chromatography, continuous chromatography, SMB, SFC, examples and industrial applications. Regulatory Fundamentals, QbD, and Design of Experiments for Biopharmaceuticals Focus on regulatory aspects, QbD/DOE principles and practical examples, Process Analytical Technology, Quality System Management, biosimilars. Tutorial (See registration form for cost) Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography Focus on analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides. Instructors Giorgio Carta, University of Virginia Alan Hunter, MedImmune Alois Jungbauer, BOKU, Vienna Massimo Morbidelli, ETH Zurich Olivier Dapremont, Ampac Fine Chemicals Lois Ann Beaver, LAB Enterprises Gisela Ferreira, MedImmune Instructors Cecilia Mazza, AkzoNobel Tony Yan, Pfizer, Inc. PREP 2016 Preliminary Scientific Program Page 1 of 22

2 Workshop 1: Sunday, July 17, at 9:00 am - 12:30 pm Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Chromatography Workshop registration is in addition to the symposium registration fee; open to conference and non-conference participants; must pre-register to attend. Focus: Biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes. This workshop will focus on the theory and practice of biomolecule chromatography. Since mass transfer and the structure of the stationary phase influence deeply chromatographic performance, the main emphasis is on describing adsorption/desorption kinetics in single and multicomponent systems and determining the relationship between stationary phase properties and process performance. The latest advances in stationary phase developments will be reviewed along with methods for their experimental characterization. Design and optimization strategies for capture and resolution applications will be discussed including multicolumn and continuous bio-chromatography processes. Topics: Adsorption equilibrium and transport in single and multicomponent systems; Stationary phases for small and large biomolecules; Design and optimization of batch processes for capture and highresolution steps; Multicolumn and continuous bio-chromatography processes; Process validation. Expert Instructors: Giorgio Carta received his Ph.D. in Chemical Engineering from the University of Delaware in Since then he has been a professor in the Department of Chemical Engineering at the University of Virginia, where his research focuses on transport phenomena and bioseparations. He regularly organizes professional courses on various aspects of bioseparations, including a course on protein chromatography development and scale-up together with Alois Jungbauer. Alan Hunter received his Ph.D. in Chemical Engineering from the University of Virginia in 2002 and is currently Fellow in the Process Biochemistry Group at MedImmune. Prior to joining MedImmune he held positions of Process Engineer at Cambrex Bio Science Baltimore, and of Senior Principal Scientist at Pfizer Biologics. Dr. Hunter has broad biotechnology experience and expertise in areas including process development for large-scale cgmp manufacture of biologics, recombinant biopharmaceutical purification, and technology transfer and scale-up. Alois Jungbauer is the head of protein technology and downstream processing at the Department of Biotechnology of the University of Natural Resources and Applied Life Sciences in Vienna (Austria). For more than 20 years, Professor Jungbauer has worked in biochemical engineering, with a focus on bioseparation, where he has published widely and holds 15 patents. For over 10 years, he has organized a biennial professional course in protein chromatography focused on mass transfer, dispersion, and scale-up. Massimo Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano in 1977, and his PhD in Chemical Engineering at the University of Notre Dame in After appointments as professor at the University of Cagliari (Italy) and at the Politecnico di Milano, since 1997 he is Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His research interests are in polymer reactions and reaction-separation processes based on continuous chromatography and in biomolecule purification with specific focus on therapeutic proteins and monoclonal antibodies. He is co-author of more than 300 papers, 11 international patents and 4 books. He serves as an associate editor of Industrial & Engineering Chemistry Research, and is a member of the scientific board of several international journals. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers. PREP 2016 Preliminary Scientific Program Page 2 of 22

3 Workshop 2: Sunday, July 17, at 12:30-4:00 pm Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC Workshop registration is in addition to the symposium registration fee; open to conference and non-conference participants; must pre-register to attend. Focus: Small molecules, APIs, peptides, oligonucleotides, chiral molecules, HPLC, column packing, gradient elution, overloaded chromatography, SFC, SMB, examples and industrial applications. This workshop will focus on development of methods for the preparative purification of small molecules for the pharmaceutical industry. After an introduction of the theory, optimization and practice of prep HPLC, SMB and SFC for small molecule separations, the instructors will present practical approaches to the development of preparative separation through a series of examples. The attendees will learn valuable information and techniques to apply in the laboratory and at manufacturing scale to increase throughput and performance. Topics: Prep HPLC batch - Theory, optimization and practice; SMB - Principle and technology; SMB - Examples and applications; SFC - Theory, equipment and examples. Expert Instructor: Olivier Dapremont received is PhD on Chemical Engineering and Applied Chemistry from University of Paris on the development of continuous chromatography for the pharmaceutical industry. He has worked on the development of SMB technology since He is currently Executive Director of Process Technologies at AMPAC Fine Chemicals where his role encompasses the development of SMB separations using multiple SMB units ranging from 4.6 mm to 1 m in diameter as well as developing continuous processes for the manufacturing of APIs. He is coauthor of several publications and patents related to the use of SMB applications for the purification of small molecules. PREP 2016 Preliminary Scientific Program Page 3 of 22

4 Workshop 3: Sunday, July 17, at 4:00-6:30 pm Regulatory Fundamentals, QbD, and Design of Experiments for Biopharmaceuticals Workshop registration is in addition to the symposium registration fee; open to conference and non-conference participants; must pre-register to attend. Focus: This workshop will focus on Quality by Design, Quality Systems Management, Science-based Risk Management, Process Analytical Technology and Continuous Process Improvement as tools that can be incorporated into basic drug development processes. We will examine the relationship between good drug development science, quality and regulatory flexibility, with emphasis on application to the biopharmaceutical industry. Particular attention will be placed on the practice of Quality by Design. A practical study of how the integration of quality and risk management is used in an application to bring a mab to market will be presented. In addition, we will address the challenges for technology and regulation created by the emerging biosimilars industry along with the current status of internationally developed guidance. Topics: Regulatory aspects, QbD, Process Analytical Technology, Quality System Management, Biosimilars Expert Instructors: Lois Ann Beaver, after a multi-decade career with the U.S. Food and Drug Administration, in 2009 founded a regulatory consulting group, LAB Enterprises. While working in FDA's Office of the Commissioner, Lois served on the FDA Pharmaceutical Quality Council that conceived and developed quality by design; led activity for FDA's joining the international Pharmaceutical Inspection Cooperation Scheme; worked as liaison with international organizations such as WHO, most recently focusing on biosimilars; managed the export program for international investigations of unapproved pharmaceuticals; was associate director for international harmonization working on international best practice and standardization activities such as the ICH; was US Coordinator for Veterinary ICH; and served as delegate to the APEC (Asia Pacific Economic Cooperation) Life Sciences Innovation Forum. Lois also led international projects on anti-counterfeiting of medical products and good manufacturing practices in pharmaceutical firms in emerging countries, and established a pharmaceutical information center in Cairo. Gisela Ferreira received her Ph.D. in Chemical Engineering from the University of Maryland Baltimore County in 2001 and is currently Senior Scientist in the Process Biochemistry Group at MedImmune. Prior to joining MedImmune she held positions as Senior Scientist at Medarex in the downstream department. Dr. Ferreira has broad biotechnology experience and expertise in areas including process development for large-scale cgmp manufacture of biologics, recombinant biopharmaceutical purification (early and late stage development), QbD, technology transfer and scale-up. PREP 2016 Preliminary Scientific Program Page 4 of 22

5 Tutorial: Monday, July 18, at 7:00-8:30 am Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography Tutorial registration is in addition to the symposium registration fee; open to conference and non-conference participants; must pre-register to attend. Focus: Analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides This workshop will focus on the practical aspects of analytical and preparative chromatography, scale-up, and how to overcome the challenges that the chromatographer encounters on a daily basis by using the tips and tricks provided. Topics: Analytical and Preparative chromatography purpose, practical scaleup, issues with peak shape, considering the whole chromatographic system (equipment, column and software) as contributors to the final chromatographic result, troubleshooting tools for improved chromatographic performance. Expert Lecturers: Cecilia Mazza has worked with small molecules, APIs, peptides and proteins for twenty five years, both in analytical as well as preparative chromatography. She is product manager and regional sales manager for Kromasil columns and bulk at AkzoNobel in Sweden. Tony Yan is currently working for Pfizer, Inc. (Groton, CT, USA) in the field of impurity isolation for structure elucidation in the department of pharmaceutical science. He has worked in pharmaceutical research and development in the area of chiral and achiral purifications, and impurity isolation for over 20 years. PREP 2016 Preliminary Scientific Program Page 5 of 22

6 Free Vendor Workshops Monday, July 18, 2016 Must pre-register at the sponsor's booth to attend; light lunch will be provided 12:45-2:00 PM Purpose-designed Protein A Resins for Improved Downstream Process and Cost Efficiency in MAb Purification, sponsored by Purolite Life Sciences The cost of Protein A resins is very high, commonly 5-10 times higher compared to standard chromatography resins. One way to address this issue is to use a less expensive Protein A resin during early clinical trials, where the risk of failure is higher and fewer cycles are run, and subsequently switch to a resin designed for manufacturing if the product makes it to PIII and beyond. The higher cost for a manufacturing resin is amortized over a large number of purification cycles. To avoid any increasing regulatory burden offsetting the potential savings, it is important that the two types of resin perform in a very similar way with respect to purification performance. Two different Protein A resins have been used in the study. Both resins are based on the same chemistry and the same alkaline-stable Protein A ligand. Characterization and performance data of the Protein A resins will be presented, including comparability data with respect to host cell proteins, DNA, leaked Protein A and aggregate content. 12:45-2:00 PM Utilizing Novel Mixed-Mode Selectivities for Challenging Chromatography Separations, Sponsored by Bio-Rad Laboratories Presenters: Jiali Liao, Ph.D., Principal Scientist I, Process Chromatography, Bio-Rad Laboratories; Mark A. Snyder, Ph.D., Manager, Applications R&D Group, Process Chromatography, Bio-Rad Laboratories; and Xuemei He, Ph.D., R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories Mixed-mode chromatography has been widely used in the purification of monoclonal antibodies (mabs), as it often provides unique selectivity unmatched by traditional ion exchange or hydrophobic interaction chromatography. An increasing number of nonantibody proteins are entering today s development pipeline. These new constructs pose purification challenges, since they are not amenable to current platform schemes. The lack of an affinity capture option often leaves a heavy burden on each step in downstream processing. In this workshop, we will illustrate the interactions between the protein molecules and mixed-mode resins in detail. We will also discuss working strategies for robust method development and optimization. The advantages of using these chromatography resins will be demonstrated by case study examples, which include efficient capture of target protein from expression culture, the removal of process impurities, and the separation of closely related species, such as product degradation fragments and high molecular weight aggregates. In summary we will discuss: interactions between protein molecules and mixed-mode resins; development of chromatographic methods; and case studies on the removal of process- and productrelated impurities. 12:45-2:00 PM Re-evaluation of the CIP Step in Insulin-related RP HPLC Processes, sponsored by DAISO Fine Chem USA, Inc. Recombinant Human Insulin, Insulin analogs, and other diabetes targeting drugs such as GLP-1 are the most important applications for industrial scale silica-based Reversed Phase High Pressure Liquid Chromatography (RP HPLC). Unfortunately, because these molecules are prone to self-aggregation and fibrillation, the columns get blocked by the inexorably forming protein goo-layer. To extend to lifetime of the column, a cleaning in place (CIP) protocol by washing the silica stationary phase with a ph 13 NaOH solution is the "necessary evil." This routinely performed CIP step has not been thoroughly calibrated: Are the current CIP protocols adequate? Is the concentration too harsh? Too mild? This presentation reports the first steps where a silica manufacturer can assist on the way to finding the answers by scientific evaluation. Simple tests will be shown that can be performed to check how adequate the CIP is with unique tools routinely used in silica manufacturing QC. Real life examples will also be presented. PREP 2016 Preliminary Scientific Program Page 6 of 22

7 Free Vendor Workshops Tuesday, July 18, 2016 Must pre-register at the sponsor's booth to attend; light lunch will be provided 12:45-2:00 PM Latest Developments of Stationary Phases for Preparative Chromatography, sponsored by AkzoNobel/Kromasil During this workshop we will share the latest developments of Kromasil materials including EternityXT, a stationary phase with organo silane merged into the base silica matrix. The high chemical and mechanical stability of EternityXT as well as its availability in bulk and pre-packed columns, makes it possible for users to run under tough ph conditions and higher temperatures across the various stages of product development including discovery, pilot plant and manufacturing in the pharmaceutical, biotech and natural product sectors. Kromasil EternityXT resistance to high alkaline concentrations for in-place regeneration as well as examples of typical applications will be presented. 12:45-2:00 PM Title TBA. Free vendor workshop sponsored by Thermo Fisher Scientific 12:45-2:00 PM Bioseparation Media by Mitsubishi Chemical, sponsored by Itochu Chemicals America/Mitsubishi Chemical Mitsubishi Chemical Corporation has manufactured industrial separation media for the pharmaceutical and food industries for more than >50 years. The various products are used for chromatographic separation of peptides and small molecules like API to large molecules like proteins. Our newest products, MabSpeed (protein A) and ChromSpeed (ion exchange) are specially designed for purification of biopharmaceuticals (antibody-drugs, protein-drugs, etc.) as well as large oligonucleotides. This purpose of this workshop is to introduce these products designed for high throughput processing. PREP 2016 Preliminary Scientific Program Page 7 of 22

8 Sunday, July 17, :00 AM - 12:30 PM Workshop 1 on Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Processes See details and pricing at PREPsymposium.org. Open to conference and non-conference participants. Must pre-register to attend. 12:30 PM - 4:00 PM Workshop 2 on Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC See details and pricing at PREPsymposium.org. Open to conference and non-conference participants. Must pre-register to attend. 4:00 PM - 6:30 PM Workshop 3 on Regulatory Fundamentals, QbD, and Design of Experiments for Biopharmaceuticals See details and pricing at PREPsymposium.org. Open to conference and non-conference participants. Must pre-register to attend. 6:00-7:30 PM Symposium Registration Open 6:00-7:30 PM Welcome Reception & Exhibition in Millennium Hall Open to all conference participants; conference name badge is required for entry. Monday, July 18, :00 AM - 8:30 AM Tutorial on Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography See details and pricing at PREPsymposium.org. Open to conference and non-conference participants. Must pre-register to attend. 7:30 AM Symposium Registration Open 10:00 AM - 5:15 PM Exhibition Open in Millennium Hall 8:30 AM Welcome and Opening Remarks Giorgio Carta, University of Virginia, Charlottesville, VA, USA PREP 2016 Preliminary Scientific Program Page 8 of 22

9 Monday, July 18, Monday Keynote: Industrial Case Studies in Protein Chromatography 8:40 AM Development of a Semi-continuous, Integrated Chromatography Purification Platform for Perfusion and High Titer Fed Batch Antibody Production. Rebecca Chmielowski, Darshini Shah, Collette Cutler, Hong Li, David Roush, Nihal Tugcu, Merck, Kenilworth, NJ, USA 9:00 AM Mechanistic Investigation of Aggregate Formation in CEX and Mitigation Strategy for an Unstable Fc-fusion Protein. Zhiqiang Chen, Chao Huang, Naresh Chennamsetty, Xuankuo Xu, ZhengJian Li, Bristol-Myers Squibb, Devens, MA, USA 9:20 AM A New Approach to Assess the Process Clearance Capability for Critical Quality Attributes. Kathlyn Lazzareschi, Josefine Persson, Genentech A member of Roche, South San Francisco, CA, USA 9:40 AM High Resolution Preparative Protein Separation using Novel ph Gradients Employing Simple Buffer Systems. Matthew Herigstad, Lihua Yang, Natarajan Ramasubramanyan, AbbVie, Westborough, MA, USA 10:00 AM Purification of Recombinant Polyclonal Antibody (rpab) Mixtures: Impact of Polishing Modality on Aggregate Selectivity and mab Component Ratios. Alan Hunter, Frank Bartnik, Hongji Liu, Xiangyang Wang, Timothy Pabst, MedImmune, Gaithersburg, MD, USA 10:20-10:50 AM Break in Millennium Exhibit Hall 2. Monday Keynote: Continuous Chromatography 10:50 AM Continuous Multicolumn Purification of Therapeutic Proteins. Fabian Steinebach, Daniel Baur, Nicole Ulmer, Lara Decker, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND 11:10 AM Continuous Purification Platforms for Viral Vectors based on Multicolumn Simulated Countercurrent Chromatography. Ricardo Silva 1, Cristina Peixoto 1, Manuel Carrondo 1, Jose Mota 2, 1 IBET, Oeiras, PORTUGAL; 2 FCT-UNL & IBET, Caparica, PORTUGAL 11:30 AM Model-based Conversion of a Single-column Batch Process to 3- and 4-Column Periodic Counter-current Chromatography. Tobias Hahn, Thiemo Huuk, Fabian Gorlich, Gang Wang, Jurgen Hubbuch, KIT, Karlsruhe, GERMANY 11:50 AM Model Predictive Control of 4-zone Simulated Moving Bed Chromatography using a Decoupled and Simplified Process Model. Ju Weon Lee, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY 12:10 PM A Rationale Approach for Comparing Different Affinity Chromatographic Processes for the Capture of a Monoclonal Antibody. Roger-Marc Nicoud 1, Laurent David 1, Margit Holzer 1, Jay Yun 2, 1 Ypso-Facto, Nancy, FRANCE; 2 Ypso-Facto, Cambridge, MA, USA 12:30-3:20 PM PAUSE, EXHIBITS, POSTERS Location: Millennium Exhibit Hall PREP 2016 Preliminary Scientific Program Page 9 of 22

10 Monday, July 18, 2016 Free Vendor Workshops Must pre-register at the sponsor's booth to attend; light lunch will be provided 12:45-2:00 PM Purpose-designed Protein A Resins for Improved Downstream Process and Cost Efficiency in MAb Purification, sponsored by Purolite Life Sciences 12:45-2:00 PM Utilizing Novel Mixed-Mode Selectivities for Challenging Chromatography Separations, sponsored by Bio-Rad Laboratories 12:45-2:00 PM Re-evaluation of the CIP Step in Insulin-related RP HPLC Processes, sponsored by DAISO Fine Chem USA, Inc. POSTER SESSION 1 2:00-3:15 PM POSTER SESSION 1 - Sponsored by Bristol-Myers Squibb Location: Millennium Exhibit Hall 3A. Monday Parallel Session: Strategies and Processes for Biomolecule Purification 3:20 PM Purification of Secretory Immunoglobulins by Chromatographic Methods. Hannah Engelmaier, Alexander Matlschweiger, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA 3:40 PM Resolution of Positional Isomers of Exenatide Mono-PEGylates by Prep Chromatography. Thi Ngoc Thanh Nguyen, Soi Yoon, E. K. Lee, Hanyang University, Ansan, SOUTH KOREA 4:00 PM Heat Precipitation of Tobacco Host Cell Proteins Facilitates Target Protein Recovery and Purification and Can be Implemented into an Automated Large-scale Manufacturing Process. Stephan Menzel, Rainer Fischer, Johannes Buyel, Fraunhofer IME, Aachen, GERMANY 4:20-4:40 PM Purification Process Development for a Recombinant F(ab )2 Antibody Fragment for PET Imaging. Mark Fitchmun 1, Kimberly Fitchmun 1, Ritsuko Sawada 2, Mark Snyder 3, Wolfgang Scholz 2, 1 Somatek Inc., San Diego, CA, USA; 2 MabVax Therapeutics, San Diego, CA, USA; 3 Bio-Rad Laboratories, Hercules, CA, USA PREP 2016 Preliminary Scientific Program Page 10 of 22

11 Monday, July 18, B. Monday Parallel Session: Stationary Phases 1 3:20 PM High Performance, Rapid Separation, and High Loading Capacity of the Novel Stationary Phase using Dual-pore Silica Beads in Reversed Phase Liquid Chromatography. Hong-zhi Bai 1, Riichi Miyamoto 1, Akie Kawamura 2, Mika Watanabe 2, Teruhiko Kanno 2, Takashi Ohtani 2, Kazuki Nakanishi 3, 1 SnG Inc., Kyoto, JAPAN; 2 Hamari Chemicals Ltd., Osaka, JAPAN; 3 Kyoto University, Kyoto, JAPAN 3:40 PM Design and Evaluation of Advanced Amsphere A3 Protein A Chromatography Resin: The Relationships and Considerations of Bead structure, Pore Structure, Surface Chemistries and Ligand Design on Affinity Resin Performance Targets. Satoshi Nakamura 1, Alpana Naresh 2, Tomonori Shiotani 1, Marty Siwak 2, 1 JSR Micro, Durham, NC, USA; 2 JSR Micro, Sunnyvale, CA, USA 4:00 PM Reducing Cost of Clinical Trials through the use of Novel Alkali Stable Protein A Resins. Hans Berg 1, Mark Hicks 2, Caroline Tinsley 2, Patrick Gilbert 2, Charlotte Vassay- Jones 2, Hans J. Johansson 1, 1 Purolite, Uppsala, SWEDEN; 2 Purolite, Llantrisant, WALES 4:20-4:40 PM Single and Multi-component IgG Adsorption on Protein A Chromatography Resins. Justin Weinberg 1, Shaojie Zhang 2, Giorgio Carta 2, Todd Przybycien 1, 1 Carnegie Mellon University, Pittsburgh, PA, USA; 2 University of Virginia, Charlottesville, VA, USA 4:40-5:10 PM Break in Millennium Exhibit Hall 4A. Monday Parallel Session: Monoliths and Membrane Chromatography 5:10 PM Evaluation of Ligand Design for Downstream Processes: Impacts of Ligand Structure on Ion-exchange Membrane Performance. Jerry Rasmussen, Cathy Bothof, Semra Colak Atan, Robert Fitzsimons, George Griesgraber, Federica Sgolastra, Andrew Vail, 3M, St. Paul, MN, USA 5:30 PM Rapid Protein Ion-exchange Separations using Surface Modified Nylon Capillarychanneled Polymer (C-CP) Fibers. Liuwei Jiang, R. Kenneth Marcus, Clemson University, Clemson, SC, USA 5:50-6:10 PM Optimization of Continuous Countercurrent Tangential Chromatography (CCTC) for Continuous Purification of Monoclonal Antibodies. Oleg Shinkazh 1, Andrew Zydney 2, 1 ChromaTan, State College, PA, USA; 2 Penn State University, State College, PA, USA 6:10 PM Pause PREP 2016 Preliminary Scientific Program Page 11 of 22

12 Monday, July 18, B. Monday Parallel Session: Stationary Phases 2 5:10 PM Mixed Mode Chromatography in Non-affinity based Purification Schemes. Carsten Voss, Bio-Rad Laboratories GmbH, Munich, GERMANY 5:30 PM Narrow-dispersion Hydrophobic Interaction Chromatographic Media for mab and ADC Separation with High Resolution. Sixi Wang, Ke Yang, Xueying Huang, Sepax Technologies, Newark, DE, USA 5:50-6:10 PM Dual Flow Chromatography for Parallel, Automated, High Throughput Process Development. Douglas Gjerde, Christopher Suh, Lee Hoang, PhyNexus Inc., San Jose, CA, USA 6:10 PM Pause Tuesday, July 19, :15 AM Symposium Registration Open 9:00 AM - 3:30 PM Exhibition Open in Millennium Hall 5. Tuesday Keynote: Preparative Chromatography in Drug Discovery, Development, and Manufacture 8:00 AM Liquid Carbon Dioxide Flash: Has the Myth Become Reality. Ray McClain, Merck, West Point, PA, USA 8:20 AM Design (and Avoidance) of Process-scale Chromatography through the use of Statistical Design of Experiments. Teri Hochdorfer, Fangfang Liu, Ke Wang, Glenn Wilcox, Pfizer, Groton, CT, USA 8:40 AM Dual Purpose Analytical SFC/UHPLC Instrument with On-line SFE Capability for Automated Method Screening of Chiral and Achiral Separations. Robert Buco 1, Masayuki Nishimura 2, Yosuke Iwata 3, Kenichiro Tanaka 4, 1 Shimadzu Corporation, Marlborough, MA, USA; 2 Shimadzu Corporation, Columbia, MD, USA; 3 Shimadzu Corporation, Kyoto, JAPAN; 4 Shimadzu Scientific Instruments Inc., Columbia, MD, USA 9:00 AM Chromatography as the Multi-tool of Drug Development and its Preparative Chiral Attachment. J. Preston, Michael McCoy, Phenomenex, Torrance, CA, USA 9:20-9:50 AM Break in Millennium Exhibit Hall PREP 2016 Preliminary Scientific Program Page 12 of 22

13 Tuesday, July 19, Tuesday Session: Understanding and Modeling Biomolecule Chromatography 9:50 AM Molecular Modeling Technique for Protein-surface Binding Free Energy Calculation and Prediction of Elution Behavior in Multimodal Chromatography. Suvrajit Banerjee, Shekhar Garde, Steven Cramer, Rensselaer Polytechnic Institute, Troy, NY, USA 10:10 AM Probing Nanoscale Effects of Ligand Density in Tentacular Ion Exchangers using X-ray Scattering. Rahul Bhambure 1, Daniel Greene 1, Yun Liu 1, Christopher Gillespie 2, Michael Phillips 2, Heiner Graalfs 3, Almut Rapp 3, Abraham Lenhoff 1, 1 University of Delaware, Newark, DE, USA; 2 MilliporeSigma, Bedford, MA, USA; 3 Merck Millipore, Darmstadt, GERMANY 10:30 AM Effect of Isotherm Nonlinearity on Protein Binding and Elution in Hydrophobic Interaction and Multimodal Chromatography. Renata Muca, Wojciech Piątkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND 10:50 AM Influence of Mixed Electrolytes and ph on Adsorption of Proteins in Hydrophobic Interaction Chromatography. Eva Hackemann, Hans Hasse, University of Kaiserslautern, Kaiserslautern, GERMANY 7. Tuesday Session: Innovative Materials and Processes for Biochromatography 11:10 AM Fluid Dynamics Simulation based on 3D pore Structure of Macro Porous Monoliths Shows High Permeability Due to Alternating Channel Width. Alois Jungbauer 1, Christian Jungreuthmayer 2, Petra Gerster 1, 1 BOKU, Vienna, AUSTRIA; 2 acib, Vienna, AUSTRIA 11:30 AM Optimization of Porous Bed Geometric Features to Maximize Adsorption of Proteins and Passage of Suspended Solids in a 3D-printed Adsorption Column. Conan Fee 1, Felix Newberry 1, Anne Gordon 1, Philip Wilson 1, Miguel Moyers-Gonzalez 1, Rua Murray 1, Tim Huber 1, Simone Dimartino 2, 1 University of Canterbury, Christchurch, NEW ZEALAND; 2 University of Edinburgh, Edinburgh, SCOTLAND 11:50 AM A Scaleable Integrated System for Temperature-controlled Fast Protein Liquid Chromatography. Owen R.T. Thomas 1, Eirini Theodosiou 2, Matthias Franzreb 3, 1 University of Birmingham, Birmingham, UK; 2 Aston University, Birmingham, UK; 3 Karlsruhe Institute of Technology, Eggenstein-Leopoldshafen, GERMANY 12:10 PM Modeling of Linear ph and Salt Gradient Elution on Weak Cation Exchange Resins. Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY 12:30-3:20 PM PAUSE, EXHIBITS, POSTERS Location: Millennium Exhibit Hall PREP 2016 Preliminary Scientific Program Page 13 of 22

14 Tuesday, July 19, 2016 Free Vendor Workshops Must pre-register at the sponsor's booth to attend; light lunch will be provided 12:45-2:00 PM Latest Developments of Stationary Phases for Preparative Chromatography, sponsored by AkzoNobel/Kromasil 12:45-2:00 PM Title TBA, sponsored by Thermo Fisher Scientific 12:45-2:00 PM Bioseparation Media by Mitsubishi Chemical, sponsored by Itochu Chemicals America/Mitsubishi Chemical POSTER SESSION 2 2:00-3:15 PM POSTER SESSION 2 - Sponsored by Bristol-Myers Squibb Location: Millennium Exhibit Hall 8A. Tuesday Parallel Session: New Developments in Affinity Chromatography 3:20 PM Making Protein A Media Stealthy. Todd Przybycien, Justin Weinberg, Carnegie Mellon University, Pittsburgh, PA, USA 3:40 PM Evaluation of Protein A Resin Degradation in a Multi-column Chromatography Process through Process Modeling and Resin Lifetime Study. Ketki Behere, Seongkyu Yoon, University of Massachusetts Lowell, Lowell, MA, USA 4:00 PM A Platform for the Development of Affinity Peptide Resins for Capture and Downstream Purification of Non-mAb Biologics. Divya Chandra, Steve Timmick, Chaz Goodwine, Nick Vecchiarello, Pankaj Karande, Steven Cramer, Chemical & Biological Engineering Rensselaer Polytechnic Institute, Troy, NY, USA 4:20-4:40 PM Development of a Continuous Protein A Capture Unit Operation: How Resin Characteristics Change the Multi-column Process. Nicolas-Julian Hilbold 1, Xavier Le Saout 2, Eric Valery 3, Jonathan Souquet 2, Laurence Muhr 4, 1 Novasep, Pompey, FRANCE; 2 Merck KGaA, Corsier-sur-Vevey, SWITZERLAND; 3 Novasep, Lyon, FRANCE; 4 LRGP (Reactions and Process Engineering Laboratory), Nancy, FRANCE PREP 2016 Preliminary Scientific Program Page 14 of 22

15 Tuesday, July 19, B. Tuesday Parallel Session: New Developments and Applications of Continuous Chromatography 3:20 PM Demonstration of a mab Chromatography Platform Process Operating in a Continuous and Integrated Mode: Flexibility for Facility Fit and Process Economics Optimization. Xhorxhi Gjoka, Rene Gantier, Mark Schofield, Pall Life Sciences, Westborough, MA, USA 3:40 PM Separation of Astaxanthin from the Crude Extract of Haematococcus Pluvialis by Simulated Moving Bed. Xiao-Qing Bao, Wen-Tung Wu, Chih-Hsiung Lin, Ya-Ting Shih, Ming-Tsai Liang, I-Shou University, Kaohsiung, TAIWAN 4:00 PM Large Scale (Ton Scale) Purification of Plant Derived Proteins using Simulated Moving Bed Chromatography. Anil Oroskar, Pravin Ninanwe, Babu Antharawalli, Priyanka Oroskar, Orochem Technologies Inc., Naperville, IL, USA 4:20-4:40 PM MCC Online Detection with Spectral Deconvolution for Achiral Separations. Xiqin Yang 1, Gary Yanik 2, Leo Hsu 1, 1 GlaxoSmithKline, King of Prussia, PA, USA; 2 PDR Separations, Palm Beach Gardens, FL, USA 9A. Tuesday Parallel Session: Column Characterization 4:50 PM Measurement and Modelling of Extra Column Volume and System Band Broadening for Scale-up of Preparative Chromatography Columns. Susanne Schweiger 1, Christian Jungreuthmayer 1, Tim Schröder 2, Alois Jungbauer 3, 1 Austrian Centre of Industrial Biotechnology, Vienna, AUSTRIA; 2 Atoll GmbH, Weingarten, GERMANY; 3 University of Natural Resources and Life Sciences, Vienna, AUSTRIA 5:10 PM Characterization and Application of Microliter Disposable Monolithic Columns (DMC)for PAT. Tanja Lukan 1, Shuichi Yamamoto 2, Noriko Yoshimoto 3, Ales Podgornik 1, 1 COBIK, Ljubljana, SLOVENIA; 2 Yamaguchi University, Ube, JAPAN; 3 Ube, JAPAN 5:30 PM Chromatographic Column Transition Analysis using Moment Analysis. Brian Youchak 1, Willis Bell 2, 1 Eli Lilly and Company, Branchburg, NJ, USA; 2 Eli Lilly and Company, Indianapolis, IN, USA 5:50-6:10 PM Planning the Execution of a Viral Clearance Study: Right First Time. Douglas Rea, Katherine Bergmann, Eurofins Lancaster Labs, Lancaster, PA, USA PREP 2016 Preliminary Scientific Program Page 15 of 22

16 Tuesday, July 19, B. Tuesday Parallel Session: Advances in Chromatographic Modalities for Bioprocess Applications 4:50 PM Flow Through Chromatography and Absorptive Depth Filtration for Continuous Bioprocessing Applications Case Studies. Romas Skudas, Paul Beckett, Merck KGaA, Darmstadt, GERMANY 5:10 PM SMART Chromatography - A Method for Packed Bed Purification from Cell Containing Feedstreams. Alistair Hurst, Derek Levison, Ruediger Welz, Franziska Meier-Haettig, emp Biotech GmbH, Berlin, GERMANY 5:30 PM Purification of Acidic Proteins with Ceramic Hydroxyapatite: Bind-and-Elute Mode or Flow-through Mode? Xuemei He, Louisa Vang, Bio-Rad Laboratories, Hercules, CA, USA 5:50-6:10 PM Bridging the Gap Between Analytical and Process Protein A Chromatography. J. Kevin O'Donnell 1, Atis Chakrabarti 1, William Evans 1, Kosuke Araki 2, Shigeru Nakatani 2, 1 Tosoh Bioscience LLC, King of Prussia, PA, USA; 2 Tosoh Corporation, Shunan, JAPAN 6:10 PM Pause 7:30 AM Symposium Registration Open Wednesday, July 20, Wednesday Keynote: Preparative Supercritical Fluid Chromatography (SFC) 8:00 AM Operating Large Diameter Columns in Liquid and Supercritical Fluid Chromatography under Strictly Adiabatic Thermal Environment. Fabrice Gritti, Joseph Jarrell, Martin Gilar, Waters Corporation, Milford, MA, USA 8:20 AM Stationary Phase Selection for Optimized Preparative SFC Chromatography. Matthew Przybyciel, ES Industries, West Berlin, NJ, USA 8:40 AM Advances in Preparative Gas-expanded Liquid Chromatography. Jerome Boni 1, Celine Morey 1, Jin Seok Hur 2, Yvan Ruland 3, 1 Novasep, Pompey, FRANCE; 2 Novasep, Boothwyn, PA, USA; 3 Novasep, Shanghai, CHINA 9:00 AM Reliable Scale-up from Linear Gradient Screening to Isocratic Bulk-purification in SFC. Jason Hill, Abhijit Tarafder, Waters, Milford, MA, USA 9:20 AM Peak Distortions in Supercritical Fluid Chromatography due to Adsorption of the Co-solvent. Torgny Fornstedt 1, Emelie Glenne 1, Jörgen Samuelsson 1, Hanna Leek 2, Kristina Ohlen 2, Magnus Klarqvist 2, 1 Karlstad University, Karlstad, SWEDEN; 2 AstraZeneca R&D Molndal, Molndal, Sweden PREP 2016 Preliminary Scientific Program Page 16 of 22

17 Wednesday, July 20, Wednesday Keynote: Preparative Purification of Peptides 9:40 AM State-of-the-Art Purification of Peptide APIs: Challenges and Achievements. Georg M. Sambeth 1, Günther Loidl 2, Ralph Schönleber 1, 1 Bachem AG, Bubendorf, SWITZERLAND; 2 Bachem Holding, Bubendorf, SWITZERLAND 10:00 AM Chemically Stable Merged Organic/Inorganic Silica Material for Purifications of Peptides and Proteins in Reversed Phase Preparative Chromatography. Fredrik Lime, Cecilia Mazza, AkzoNobel/Kromasil, Bohus, SWEDEN 10:20 AM Influence of Column Overloading on Selectivity in Peptide Purification. Guido Krautz 1, Tivadar Farkas 2, Marc Jacob 2, 1 Phenomenex LTD, Aschaffenburg, GERMANY; 2 Phenomenex Inc., Torrance, CA, USA 10:40-11:10 AM Break in Commonwealth Foyer 12. Wednesday Session: Chromatography for Virus Particles 11:10 AM Combining Solute Surface Analytics and High Throughput Screening to Define Binding Mechanisms of Virus Particles to Multimodal Anion Exchange Resin. Matthew Brown 1, Sarah Johnson 1, Kurt Brorson 1, Scott Lute 1, David Roush 2, Joseph Hughes 3, Mike Burnham 3, 1 US Food and Drug Administration, Silver Spring, MD, USA; 2 Merck, Kenilworth, NJ, USA; 3 WuXi Apptec, Philadelphia, PA, USA 11:30 AM Positive and Negative Mode Multi-column Processes for Enveloped Virus-like Particles Purification. Ricardo Silva 1, Alex Xenopoulos 2, Paula Alves 3, Manuel Carrondo 4, Cristina Peixoto 3, 1 ibet, Oeiras, PORTUGAL; 2 EMD Millipore, Bedford, MA, USA; 3 ibet/itqb, Oeiras, PORTUGAL; 4 ibet/fct-unl, Oeiras, PORTUGAL 11:50 AM Purification of Cell Culture-based Influenza Virus Particles using Membrane Filters with the Aid of Non-ionic Polymers. Pavel Marichal-Gallardo 1, Michael Martin Pieler 1, Michael Wolff 2, Udo Reichl 2, 1 Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY; 2 Max Planck Institute for Dynamics of Complex Technical Systems & Chair of Bioprocess Engineering at Otto von Guericke University Magdeburg, Magdeburg, GERMANY 12:10 PM The Assembly Phase of Virus-Like Particles Contributes Significantly to Separation and Purification. Mike Zhang, Frank Gillam, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA 12:30-12:40 PM Presentation of Awards to Winners of the Best Poster Competition 12:40-1:40 PM Lunch on own PREP 2016 Preliminary Scientific Program Page 17 of 22

18 Wednesday, July 20, Wednesday Session: Chromatography Fundamentals 1:40 PM Experimental and Theoretical Analysis of Chromatographic Processes in the Presence of Liquid-liquid Phase Separation. Franziska Ortner, Marco Mazzotti, ETH Zurich, Zurich, SWITZERLAND 2:00 PM The Loadability and Retention Behavior of Zwitterionic Stationary Phases. Attila Felinger, University of Pecs, Pecs, HUNGARY 2:20 PM Improving the Productivity of Capture Chromatography based on a Simplified Mechanistic Model. Noriko Yoshimoto, Sumiko Hasegawa, Shuichi Yamamoto, Yamaguchi University, Ube, JAPAN 2:40 PM Robust Multi-objective Optimization of Chromatographic Rare Earth Element Separation. Hans-Kristian Knutson, Anders Holmqvist, Bernt Nilsson, Lund University, Lund, SWEDEN 3:00 PM A Concurrent Approach for Isotherm Determination and Design of Simulated Moving Bed Process for Multicomponent Systems. Pranav Vengsarkar, Siwei Guo, Jason Bentley, Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA 14. Wednesday Session: Advances in CPC, CCC, and Chiral Separations 3:20 PM How Can Ion-pair CPC Make Joke of RPC at Preparative Levels? Laszlo Lorantfy 1, Dora Rutterschmidt 1, Zsolt Kovacs 2, Ying Hou Guan 3, Laszlo Frici Nemeth 1, 1 RotaChrom Technologiai, Dabas, HUNGARY; 2 ELTE, Budapest, HUNGARY; 3 BME, Budapest, HUNGARY 3:40 PM Spiral Countercurrent Chromatography for Preparative Separations using Aqueous Two-phase Solvent Systems. Rodrigo Lazo-Portugal 1, Steingrimur Stephansson 2, Saeyoung Nate Ahn 2, Martha Knight 1, 1 CC Biotech LLC, Rockville, MD, USA; 2 Fuzbien Technology Inst., Rockville, MD, USA 4:00 PM Cost-effectiveness Modeling to Understand the Contribution of Preparative Chiral Separations in Pharmaceutical R&D. Jeffrey Kiplinger, Paul Lefebvre, Emily Rouse, Keith Galyan, Averica Discovery, Marlborough, MA, USA 4:20 PM Resolution of Mandelic Acid Enantiomers by Coupling Separation with Enantioselective Chromatography and Enzymatic Racemization. Katarzyna Wrzosek, Katja Bettenbrock, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY 5:00 PM CLOSING REMARKS, Giorgio Carta, University of Virginia, Charlottesville, VA, USA 5:10 PM Farewell Reception PREP 2016 Preliminary Scientific Program Page 18 of 22

19 PREP 2016 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See link to poster guidelines under Author Instructions at PREPsymposium.org Click here to submit abstracts online PuroPhase SPE Reverse Phase - A New Complete Platform for SPE. Christopher Bresner 1, Ksenia Sochilina 2, Alessandra Basso 1, 1 Purolite, Llantrisant, UK; 2 Purolite, Moscow, RUSSIA Multicolumn Cyclic System for Protein Separation in Gradient Mode. Roman Bochenek, Rafał Gorczyca, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND PCR Based Cloning: A Fast, Cheap, and Easy Way to Customize Proteins at the DNA Level. Imen Tanniche, Amanda Fisher, Ryan Senger, Mike Zhang, Frank Gillam, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA Determination of Scale-down Criteria and Evaluation of Different Pumping Modes to Mimic Commercial Scale Viral Filter Performance. Prasad Pathange, Bayer HealthCare, Berkeley, CA, USA Thermodynamic Analysis of Multiple Components Resolution in Chromatography at Various Temperatures. Gorgi Pavlov, James T. Hsu, Lehigh University, Bethlehem, PA, USA Process Design Strategy to Monitor and Improve Purification of Influenza Virus-Like Particles using Click Chemistry. Sofia Carvalho 1, Ricardo Silva 3, Joao Freire 2, Mafalda Moleirinho 3, Francisca Monteiro 1, Diana Gaspar 2, Miguel Castanho 2, Paula Alves 1, Gonçalo Bernardes 4, Cristina Peixoto 1, Manuel Carrondo 5, 1 IBET/ITQB-UNL, Oeiras, PORTUGAL; 2 IMM, Lisboa, PORTUGAL; 3 IBET, Oeiras, PORTUGAL; 4 IMM/University of Cambridge, Lisboa/Cambridge, Portugal/UK; 5 IBET/ITQB-UNL/FCT-UNL, Oeiras/Caparica, PORTUGAL Downstream Processing of Influenza Virus-like Particles using an All-filtration Technology Platform. Sofia Carvalho 1, Ricardo Silva 2, Barbara Cunha 1, Mafalda Moleirinho 2, Alex Xenopoulos 3, Paula Alves 1, Cristina Peixoto 1, Manuel Carrondo 4, 1 IBET/ITQB-UNL, Oeiras, PORTUGAL; 2 IBET, Oeiras, PORTUGAL; 3 EMD Millipore, Boston, MA, USA; 4 IBET/ITQB-UNL/FCT-UNL, Oeiras/Caparica, PORTUGAL Anticancer Effect of the Ethyl Acetate Extract from Cuscuta campestris and Its Active Compounds. Emine Kılıçkaya Selvi 1, Emine Akyüz Turumtay 1, Havva Er 1, Halbay Turumtay 2, Cemal Sandallı 1, 1 Recep Tayyip Erdogan University, Rize, TURKEY; 2 Karadeniz Technical University, Trazon, TURKEY Determination of Benzo(a)pyrene by Solid Phase Extraction Combined to UPLC with Fluorimetric Detection in Human Breast Milk. Isil Gazioglu, Serife Evrim Kepekci Tekkeli, Bezmialem Vakif University, Istanbul, TURKEY Flow Through Chromatography A Powerful Purification Tool for Naked and Enveloped Viruses. Ricardo Silva 1, Alex Xenopoulos 2, Paula Alves 3, Manuel Carrondo 4, Cristina Peixoto 4, 1 ibet, Oeiras, PORTUGAL; 2 EMD Millipore, Bedford, MA, USA; 3 ibet/itqb, Oeiras, PORTUGAL; 4 ibet/fct-unl, Oeiras, PORTUGAL PREP 2016 Preliminary Scientific Program Page 19 of 22

20 PREP 2016 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See link to poster guidelines under Author Instructions at PREPsymposium.org Click here to submit abstracts online An Empirical Design Approach of Multi-column Chromatographic Processes for Enveloped Virus-like Particles Purification. Ricardo Silva 1, Alex Xenopoulos 2, Paula Alves 3, Manuel Carrondo 4, Cristina Peixoto 3, 1 ibet, Oeiras, PORTUGAL; 2 EMD Millipore, Bedford, MA, USA; 3 ibet/itqb, Oeiras, PORTUGAL; 4 ibet/fct-unl, Oeiras, PORTUGAL Preparative SFC used to Prepare Samples of Trace Unknowns from Synthetic Products in Order to Study them in their Pure Form: Application of Analytical Techniques to the Purified Unknown Samples Gives the Knowledge Necessary for their Full Structural Elucidation. John McCauley 1, Marian Twohig 2, 1 Waters Corporation, New Castle, DE, USA; 2 Waters Corporation, Milford, MA, USA Development of a Two-step, cgmp-compliant Process for Adenovirus Purification. Mark Fitchmun 1, John Chicca 2, Mark Snyder 3, 1 Somatek, San Diego, CA, USA; 2 Molecular Diagnostic Systems, San Diego, CA, USA; 3 Bio-Rad Laboratories, Hercules, CA, USA Evaluation of Loading Characteristics and IgG Binding Performance of Staphylococcal Protein A on Polypropylene Capillary-channeled Polymer Fibers. Hung Trang 1, Abby Schadock-Hewitt 2, Liuwei Jiang 1, R. Kenneth Marcus 1, 1 Clemson University, Clemson, SC, USA; 2 Bristol-Myers Squibb, Devens, MA, USA Experimental Validation of Relay Simulated Moving-bed Chromatography. Jose Mota 1, Ricardo Silva 2, 1 LAQV/REQUIMTE & IBET, Caparica, PORTUGAL; 2 IBET, Oeiras, PORTUGAL Continuous Purification Platforms for Viral Vectors based on Multicolumn Simulated Countercurrent Chromatography. Jose Mota 1, Ricardo Silva 2, Cristina Peixoto 2, Manuel Carrondo 2, 1 LAQV/REQUIMTE and IBET, Caparica, PORTUGAL; 2 IBET, Oeiras, PORTUGAL Ceramic Hydroxyapatite for the Polish Purification of an Acidic Recombinant Enzyme CDP-D- Glucose 4, 6-Dehydratase. Louisa Vang, Xuemei He, Bio-Rad Laboratories, Hercules, CA, USA Application of Spiral Countercurrent Chromatography to Natural Product Separation. Cuiping Chen 1, William Folk 2, Thomas Finn 1, Martha Knight 1, 1 CC Biotech LLC, Rockville, MD, USA; 2 University of Missouri, Rolla, MO, USA Single and Multi-component IgG Adsorption on Protein A Chromatography Resins. Justin Weinberg 1, Shaojie Zhang 2, Giorgio Carta 2, Todd Przybycien 1, 1 Carnegie Mellon University, Pittsburgh, PA, USA; 2 University of Virginia, Charlottesville, VA, USA Experimental Realization of Single-column Batch Chromatography with Recycle Lag. Abimaelle Chimerio, Snezana Reljic, Rui Ribeiro, Jose Mota, LAQV/REQUIMTE, Caparica, PORTUGAL Extractive Sample Introduction in Preparative Supercritical Fluid Chromatography. Geoffrey Cox 1, Mohamed Shaimi 2, 1 PIC Solution Inc., Media, PA, USA; 2 PIC Solution SAS, Avignon, FRANCE Evaluation of a Novel Adsorptive Anion Exchange Hybrid Purifier for Biopharmaceutical Harvest Clarification and Impurity Reduction. Michael McGarrah, Hiren Ardeshna, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA PREP 2016 Preliminary Scientific Program Page 20 of 22

21 PREP 2016 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See link to poster guidelines under Author Instructions at PREPsymposium.org Click here to submit abstracts online Statistical Evaluation of Performance Parameters of Pre-packed Columns over a Time Span of Ten Years. Tim Schroeder 1, Theresa Scharl Hirsch 2, Christian Jungreuthmayer 2, Astrid Durauer 3, Alois Jungbauer 3, 1 Atoll GmbH, Weingarten, GERMANY; 2 Austrian Centre of Industrial Biotechnology, Vienna, AUSTRIA; 3 University of Natural Resources and Life Sciences, Vienna, AUSTRIA In silico Modeling of Cation Exchange Chromatography Gradient Elution on Model Systems to Develop Practical Guidelines for Step Optimization. Chris Gerberich, Andre Dumetz, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA Modeling of Anion-Exchange Chromatography: Influence of Ligand Densities on Protein Separation. Felix Wittkopp 1, Lars Peeck 2, Heiner Graalfs 2, Christian Frech 1, 1 Hochschule Mannheim University of Applied Sciences, Mannheim, GERMANY; 2 Merck KGaA, Darmstadt, GERMANY A Comparison of Ordered Internal Column Morphologies Manufactured using 3D Printing. Suhas Nawada 1, Conan Fee 1, Simone Dimartino 2, 1 University of Canterbury, Christchurch, NEW ZEALAND; 2 The University of Edinburgh, Edinburgh, UK Modeling of Linear ph and Salt Gradient Elution on Weak Cation Exchange Resins. Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY Robust Multi-objective Optimization of Chromatographic Rare Earth Element Separation. Hans-Kristian Knutson, Anders Holmqvist, Bernt Nilsson, Lund University, Lund, SWEDEN In-Silico Process Development: Success Stories. Teresa Beck 1, Thiemo Huuk 1, Tobias Hahn 1, Juergen Hubbuch 2, 1 GoSilico, Karlsruhe, GERMANY; 2 Karlsruhe Institute of Technology, Karlsruhe, GERMANY Simplifying the Purification Process for PEGylated Erythropoietin by using a Combined Experimental/Modeling Development Approach. Roberto Falkenstein, Bernhard Spensberger, Ferdinand Stueckler, Jan Griesbach, Markus Haberger, Michaela Hook, Wolfgang Koehnlein, Ulrich Schilhabel, Ulrike Strauss, Roche Diagnostics GmbH, Penzberg, GERMANY Purification of Secretory Immunoglobulins by Chromatographic Methods. Hannah Engelmaier, Alexander Matlschweiger, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA Model-based Conversion of a Single-column Batch Process to 3- and 4-Column Periodic Counter-current Chromatography. Tobias Hahn, Thiemo Huuk, Fabian Gorlich, Gang Wang, Jurgen Hubbuch, KIT, Karlsruhe, GERMANY PREP 2016 Preliminary Scientific Program Page 21 of 22