—PREP 2015 Preliminary Scientific Program— Click Here to Submit your Poster Abstract (program as of 6/5/2015) Message from the PREP 2015 Organizing Committee We are delighted to proudly introduce the PREP 2015 Preliminary Scientific Program. The program includes four state-of-the-art Training Workshops with new lecturers and updated coverage, an Oral Program with 74 oral papers, and two Poster Sessions with about 50 papers already accepted and many more likely to come during the next three months. The 74 oral papers were selected from more than 110 oral abstracts, based on ratings by the Scientific Committee reflecting quality and impact as well as the need to provide a balanced coverage of critical topics. Unfortunately, because of space constraints, it was not possible to include many very deserving submissions in the oral program. Thus, many outstanding papers originally submitted for oral will be presented in the Poster Program. As a result, we expect the Poster Program to be truly excellent. All oral presenters are given the opportunity to also showcase their work in the Poster Session, creating a vibrant, interesting, and up-to-date showcase of the very latest scientific advances in prep/process chromatography. All posters presented will be entered in the Best Poster Award Competition and winners will be recognized at the end of the Wednesday morning sessions. We encourage everyone to join the PREP 2015 Poster Program. th th Deadlines for poster abstract submissions are June 15 for inclusion in the final program and July 14 for last minute posters. Sunday, July 26, 2015 Workshop Offerings to Fast-track Your Knowledge Training to learn about various aspects of process chromatography will be presented on the Sunday preceding the meeting. Certificates of completion recognizing attendance will be awarded. The PREP Symposium reserves the right, without notice, to modify the workshop material or schedules, as well as to amend the roster of workshop presenters. For details describing the workshops and costs, please see http://prepsymposium.org/workshop-sunday.html Must pre-register to attend workshops; open to meeting and non-meeting attendees. 9:00 AM - 12:30 PM WORKSHOP 1: Preparative Chromatography for Biomolecule Purification 9:00 AM - 12:30 PM WORKSHOP 2: Preparative Chromatography for Purification of APIs 3:30 PM - 6:30 PM WORKSHOP 3: Continuous Chromatography for Biomolecule Purification 1:30 PM - 4:30 PM WORKSHOP 4: Regulatory Fundamentals and QbD for Biopharmaceuticals 6:00 - 7:30 PM Symposium Registration Open 6:00 - 7:30 PM Welcome Reception & Exhibition in Millennium Hall PREP 2015 Preliminary Scientific Program Page 1 Sunday, July 26, 2015 EDUCATIONAL TRAINING WORKSHOP PROGRAM Must pre-register to attend workshops; open to meeting and non-meeting attendees WORKSHOP 1 - Preparative Chromatography for Biomolecule Purification 9:00am - 12:30pm Focus: Biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and step elution. 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 high-resolution applications will be discussed. Topics: Adsorption equilibrium and transport in single and multicomponent systems; Stationary phases for small and large biomolecules; Design and optimization for capture and high-resolution steps. Lecturers: Giorgio Carta received his Ph.D. in Chemical Engineering from the University of Delaware in 1984. 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 Principal Scientist 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. PREP 2015 Preliminary Scientific Program Page 2 Sunday, July 26, 2015 EDUCATIONAL TRAINING WORKSHOP PROGRAM Must pre-register to attend workshops; open to meeting and non-meeting attendees WORKSHOP 2 - Preparative Chromatography for Purification of APIs 9:00am - 12:30pm Focus: Small molecules, HPLC, column packing, gradient elution, overloaded chromatography, SFC, SMB, examples and industrial applications. This workshop will focus on development of method 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. Lecturers: Olivier Dapremont has worked on the development of SMB technology since 1992. He is 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. Larry Miller has worked in the small molecule purification area for over thirty years, utilizing batch, semi-continuous and continuous technologies. He is a principal scientist at Amgen in Cambridge, MA where he is responsible for purification support for medicinal and process chemistry. PREP 2015 Preliminary Scientific Program Page 3 Sunday, July 26, 2015 EDUCATIONAL TRAINING WORKSHOP PROGRAM Must pre-register to attend workshops; open to meeting and non-meeting attendees WORKSHOP 3 - Continuous Chromatography for Biomolecule Purification 3:30pm - 6:30pm Focus: Focus on continuous chromatography for biomolecules, isotherms for bio-molecules, SMB basic principles, difference between SMB for small molecules and SMB for biomolecules, challenges, practical examples. Chromatographic processes are essential for the downstream purification of bio-molecules. During the last 10 years, a tremendous increase in the upstream expression levels, especially for monoclonal antibodies requires a significant shift in the downstream approach. To overcome "bottlenecks", the implementation of Multi-Column Continuous Chromatography (Bio-MCC) became of interest. Therefore, the workshop will introduce the audience to the fundamentals on Bio-MCC and provide guidelines for the process and equipment design after reviewing the downstream chromatographic processes and the Simulated Moving Bed (SMB) technology. The workshop will present applications and current developments. Although, the SMB technology has a proven record to bring synthetic pharmaceuticals faster to the market and to purify non-pharmaceutical bio-molecules at a large industrial scale; barriers still remain to implement the technology into the bio-pharmaceutical industry. These barriers will be identified and ways how to eliminate them. In particular, eliminating barriers related to column and equipment hardware, packing material, solvent systems, CIP of the systems, bio-molecule characteristics and regulatory constrains to allow continuous chromatographic processes to become part of the processing platform in the bio-pharmaceutical industry. This workshop is a complement to the basics of prep chromatography presented in the morning. Topics: Simulated Moving Bed and Multicolumn Continuous Chromatography technology for biomolecules, fundamentals and design criteria, challenges and opportunities, regulatory constraints Lecturers: Kathleen Mihlbachler has worked in the field of process chromatography for more than 15 years. Currently she is the Global Director of Separations Development at IPT Integrated Process Technology – A member of LEWA-Nikkiso Group (future LEWA Process Technology). She is responsible for the development of separation technologies for synthetic and biological molecules, in particular for continuous processing. Prior to this appointment Dr. Mihlbachler worked as an external consultant for LEWA-NIKKISO since 2012 where she has supported the technical transfer of process chromatographic technology and consulted in customer projects. Previously, Dr. Mihlbachler was involved as a Sr. Researcher at BMS, Eli Lilly and Pfizer in the development, scale-up and manufacturing of purification/separation processes for chiral and non-chiral compounds, peptides and proteins, in particular to implement continuous processes. From 2011 to 2013, Dr. Mihlbachler has taught undergraduate courses for chemical and biomedical students in the Department of Chemical, Biological and Pharmaceutical Engineering at New Jersey Institute of Technology. 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 1986. After his first appointments as professor at the University of Cagliari (Italy) and then at the Politecnico di Milano, he is, since 1997, Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). His main research interests are in Chemical Reaction Engineering, with particular emphasis on polymer reactions and reaction-separation processes based on continuous chromatography. More recently, his interest in chromatographic separations is evolved in the area of biomolecules with specific focus on therapeutic proteins and monoclonal antibodies. The general aim of his research is the development of new concepts for the downstream processing of these materials. Massimo Morbidelli is co-author of more than 300 papers, 11 international patents and four books. He serves as an associate editor of the journal of Industrial & Engineering Chemistry Research, and is a member of the scientific board of several international scientific journals. He is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers. PREP 2015 Preliminary Scientific Program Page 4 Sunday, July 26, 2015 EDUCATIONAL TRAINING WORKSHOP PROGRAM Must pre-register to attend workshops; open to meeting and non-meeting attendees WORKSHOP 4 - Regulatory Fundamentals and QbD for Biopharmaceuticals 1:30pm - 4:30pm 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, Marketing Lecturers: 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 2015 Preliminary Scientific Program Page 5 Monday, July 27, 2015 7:15 AM Symposium Registration Open 10:15 AM - 5:15 PM Exhibition Open in Millennium Hall 8:00 AM Welcome and Opening Remarks Giorgio Carta, University of Virginia, Charlottesville, VA, USA 1. Monday Keynote: In Memory of Georges Guiochon Session Chairs: Kathleen Milhbachler, LEWA-Nikkiso, Devens, MA, USA, and Igor QuinonesGarcia, Shire, Lexington, MA, USA 8:10 AM Opening Remarks 8:20 AM The Georgesian Optimization of Chromatography and Life. Attila Felinger, University of Pecs, Pecs, HUNGARY 8:45 AM Integration of Up- and Downstream Continuous Processing for the Manufacture of Therapeutic Proteins. Massimo Morbidelli, Fabian Steinebach, Daniel Karst, Thomas Villiger, Miroslav Soos, ETH Zurich, Zurich, SWITZERLAND 9:10 AM Inflection Points in Single Component Adsorption Isotherms and Consequences for Preparative Chromatography. Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY 9:35 AM Combining Theory and Practice for a Deeper Understanding of the Separation Process. Torgny Fornstedt, Karlstad University, Uppsala, SWEDEN 10:00 AM Contribution of the Accurate Measurement of Thermodynamic and Kinetic Properties to the Performance Improvement of Separation Systems. Fabrice Gritti, University of Tennessee, Knoxville, TN, USA 10:25 AM Closing Remarks and Presentation 10:35-11:10 AM Break in Millennium Exhibit Hall PREP 2015 Preliminary Scientific Program Page 6 2. Monday Keynote: Industrial Case Studies in Protein Chromatography Session Chair: Giorgio Carta, University of Virginia, Charlottesville, VA, USA 11:10 AM Engineering of Novel Protein A Ligands to Enable Milder Elution pH and High 1 2 2 2 Dynamic Binding Capacity. Timothy Pabst , Ronnie Palmgren , Annika Forss , Jelena Vasic , 1 1 1 1 1 Mariko Fonseca , Christopher Thompson , William Wang , Xiangyang Wang , Alan Hunter , 1 2 MedImmune, Gaithersburg, MD, USA; GE Healthcare, Uppsala, SWEDEN 11:30 AM Development and Implementation of High Throughput Miniature Columns in mAb Process Development. John Welsh, Haiying Bao, Michael Rauscher, Thomas Linden, David Roush, Jennifer Pollard, Merck & Co. Inc, Kenilworth, NJ, USA 11:50 AM Integration of High Throughput Process Development with Empirical Modeling 1 2 1 1 Approaches. Gregory Barker , Arch Creasy , Joseph Calzada , Nate Domagalski , Zheng 1 1 2 1 1 Ouyang , Sibylle Herzer , Giorgio Carta , Siegfried Rieble , Bristol-Myers Squibb, Bloomsbury, 2 NJ, USA; University of Virginia, Charlottesville, VA, USA 12:10 PM Isolation and Characterization of Antibody Fragments Lacking One or Two Light Chains. Thomas von Hirschheydt, Roche Pharma Research & Early Development, Penzberg, GERMANY 12:30-3:20 PM PAUSE, EXHIBITS, POSTERS (lunch on own) 12:45-2:00 PM FREE VENDOR WORKSHOPS 2:00-3:20 PM "Praesto, A New Range of High Performance Agarose Resins Designed for Large Scale Protein Purification" sponsored by Purolite "Bioseparation Media" sponsored by Mitsubishi Chemical Corporation POSTER SESSION I in Millennium Exhibit Hall Poster Session Chairs: Arvind Rajendran, University of Alberta, Alberta, CANADA, and Owen Thomas, University of Birmingham, UK 3A. Monday Parallel Session: Strategies and Processes for Biomolecule Purification Session Chair: David Robbins, MedImmune, Gaithersburg, MD, USA 3:20 PM Flow-Through Chromatography. Turbocharged. Peter Gagnon, Richard Nian, Wei Zhang, Hui Theng Gan, Bioprocessing Technology Institute, Singapore, SINGAPORE 3:40 PM Preparative Chromatofocusing of Monoclonal Antibodies: Modelling of Linear pH Gradient and pH-Step Elution. Simon Kluters, Yi Feng Lee, Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY 4:00 PM Multicomponent Adsorption of GFP on Anion Exchange Resins. Rainer Hahn, Sabine Necina, Bernhard Sissolak, BOKU, Vienna, AUSTRIA 4:20 PM Development of a 3-Month Affinity Purification Discovery Platform Technology. Kevin Isett, Warren Kett, Avitide Inc., Lebanon, NH, USA 4:40-5:10 PM Break in Millennium Exhibit Hall PREP 2015 Preliminary Scientific Program Page 7 3B. Monday Parallel Session: Stationary Phases I Session Chair: Andreas Seidel-Morgenstern, Max Planck Institute, Magdeburg, GERMANY 3:20 PM Merged Organic/Inorganic Silica Material for Purifications in Reversed Phase Preparative Chromatography at Elevated pH. Fredrik Lime, Robert Fredriksson, Per Jageland, Joakim Högblom, AkzoNobel/Kromasil, Bohus, SWEDEN 3:40 PM Tracing the Trend of Increasing Productivity in Prep Chromatography with use of 1 Immobilized Polysaccharide Derived Chiral Stationary Phases. Joseph Barendt , Pilar 2 1 2 Franco , Chiral Technologies, West Chester, PA, USA; Chiral Technologies Europe, Strasbourg, FRANCE 4:00 PM Characterization of a Newly Developed Hydroxyapatite Resin for the Separation of Biomolecules. William Evans, Chakrabarti Atis, Tosoh Bioscience LLC, King of Prussia, PA, USA 4:20 PM Design of Novel, Alkaline Stable, Protein A Resins. Hans J. Johansson, Hans Berg, Patrick Gilbert, Mark Hicks, Caroline Tinsley, Purolite, Llantrisant, UK Break in Millennium Exhibit Hall 4:40-5:10 PM 4A. Monday Parallel Session: Process Modeling and Design Session Chair: Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND 5:10 PM Chromatographer: What Could Modeling Do for You? Roger-Marc Nicoud, YpsoFacto, Nancy, FRANCE 5:30 PM Process Design Method for Capture Chromatography based on a Simplified 1 1 1 2 Mechanistic Model. Noriko Yoshimoto , Yu Isakari , Shuichi Yamamoto , Ales Podgornik , 1 2 Yamaguchi University, Ube, JAPAN; University of Ljubljana and COBIK, Ljubljana, SLOVENIA 5:50-6:10 PM Unified Design of Chromatographic Separation Processes. Tuomo Sainio, Jani Siitonen, Lappeenranta University of Technology, Lappeenranta, FINLAND 6:10 PM Pause 4B. Monday Parallel Session: Stationary Phases II Session Chair: Yan Yao, Bristol-Myers Squibb, Pennington, NJ, USA 5:10 AM MAb Aggregate Removal with a New Type of Anion Exchange Resin. Egbert 1 2 1 1 Mueller , Patrick Endres , Judith Vajda , Tosoh Bioscience GmbH, Stuttgart, GERMANY; 2 Tosoh Bioscience GmbH, Stuttgart, GERMANY 5:30 PM Purification Routes for New Antibody Formats and Non-mAb Proteins. Carsten Voss, Bio-Rad Laboratories GmbH, Munich, Bavaria, GERMANY 5:50 PM Evaluation of an Antibody Capture Step using a High Capacity Protein A Chromatography Medium from a Quality by Design Perspective. Martin Antti, Charlotte Brink, Anna Gronberg, Per-Mikael Aberg, GE Healthcare Bio-Science, Uppsala, SWEDEN 6:10 PM Pause PREP 2015 Preliminary Scientific Program Page 8 Tuesday, July 28, 2019 FREE VENDOR WORKSHOP 6:30-8:00 AM "TBA" sponsored by Thermo Fisher Scientific 7:15 AM Symposium Registration Open 9:20 AM - 3:30 PM Exhibition Open in Millennium Hall 5. Tuesday Keynote: Preparative Chromatography in Medicinal Chemistry, Drug Discovery and Development Session Chair: Larry Miller, Amgen, Cambridge, MA, USA 8:00 AM Integrated Purification Solutions for Medicinal Chemistry and High-Throughput Synthesis In Pharmaceutical Discovery. Philip Searle, AbbVie Inc, North Chicago, IL, USA 8:20 AM Development of a Nucleotide Sugar Purification Method using a Mixed Mode Column. Heather Eastwood, Wesley Barnhart, Fang Xia, John Jordan, Kyung-Hyun Gahm, Amgen, Thousand Oaks, CA, USA 8:40 AM Impurity Isolation by Utilizing Multiplatform Chromatographic Systems in Parallel – A Systematic Approach. Jimmy O. DaSilva, Fuh-Rong Tsay, Lisa Frey, Eric Streckfuss, Merck & Co. Inc., Rahway, NJ, USA 9:00 AM Merck Automated Purification for Drug Discovery. Kuanchang Chen, Merck & Co. Inc., Kenilworth, NJ, USA 9:20-9:50 AM Break in Millennium Exhibit Hall 6. Tuesday Session: Understanding and Modeling Biomolecular Interactions in Chromatographic Purification Session 6: Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND 9:50 AM Characterization of Lysozyme Adsorption in Cellulosic Chromatographic Materials using Small-angle Neutron Scattering. Stijn Koshari, Norman Wagner, Abraham Lenhoff, University of Delaware, Newark, DE, USA 10:10 AM Molecular Modeling Techniques to Predict Binding Free Energies of Proteins to Multimodal Chromatographic Surfaces. Suvrajit Banerjee, Shekhar Garde, Steven Cramer, Rensselaer Polytechnic Institute, Troy, NY, USA 10:30 AM Molecular Dynamics as a Stepping Stone for Advanced Chromatography Modeling. Anna Osberghaus, Katharina Lang, Florian Pilgram, Jürgen Hubbuch, Karlsruhe Institute of Technology, Karlsruhe, GERMANY 10:50 AM Solubility Pattern of Proteins in Overloaded Gradient Chromatography. Izabela Poplewska, Michal Kolodziej, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND PREP 2015 Preliminary Scientific Program Page 9 7. Tuesday Session: Innovative Chromatographic Materials Session Chair: Alois Jungbauer, BOKU, Vienna, AUSTRIA 1 11:10 AM Magnetic Fishing Games - Seriously Attractive Separations. Owen Thomas , Alfred 1 1 2 1 Fernandez-Castane , Tim Overton , Matthias Franzreb , University of Birmingham, Edgabston 2 Birmingham, UNITED KINGDOM; Karlsruhe Institute of Technology, Leopoldshafen Karlsruhe, GERMANY 11:30 AM Disrupting the Packed Bed: 3D Printing of Chromatography Columns. Conan Fee, Simone Dimartino, Don Clucas, Tim Huber, Suhas Nawada, Fabian Dolamore, Anne Gordon, Roya Rezanavaz, University of Canterbury, Christchurch, NEW ZEALAND 11:50 AM Poly-Electrolyte Brushes and Adsorption Isotherms. Rushd Khalaf, Massimo Morbidelli, Institute for Chemical and Bioengineering, Department of Chemistry and Applied Biosciences, ETH Zurich, Zurich, SWITZERLAND 12:10 PM Lipid Tethered Ligands (LTLs): Versatile and Robust Coupling Chemistries for the Modification of Hydrophobic Support Phases. R. Kenneth Marcus, Liuwei Jiang, Paul J. Haupt-Renaud, Clemson University, Clemson, SC, USA 12:30-3:20 PM PAUSE, EXHIBITS, POSTERS (lunch on own) 12:45-2:00 PM FREE VENDOR WORKSHOPS "Advances in the Development of Stationary Phases for Preparative Chromatography" sponsored by AkzoNobel "New LPLC Pilot and Production Platform with Buffer In Line Capability" sponsored by LEWA-Nikkiso America POSTER SESSION II in Millennium Exhibit Hall 2:00-3:20 PM Poster Session Chairs: Arvind Rajendran, University of Alberta, Alberta, CANADA, and Owen Thomas, University of Birmingham, UK 8A. Tuesday Parallel Session: Continuous Chromatography I Session Chairs: Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA, and Jose Paulo Mota, FCT/UNL & IBET, Caparica, PORTUGAL 3:20 PM Process Development for Intermediates and APIs. Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA 3:40 PM SMB Chromatography with Internal Recycle to Isolate Intermediately Adsorbing 1 2 Stereoisomers from Complex Mixtures. Dawid Kiwala , Dorota Antos , Andreas Seidel1 1 Morgenstern , Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, 2 GERMANY; Rzeszow University of Technology, Rzeszow, POLAND 4:00 PM Model-based Deterministic Approach for Optimizing Design and Operation of 1 2 1 Simulated Moving Bed Reactor. Shan Tie , Balamurali Sreedhar , Gaurav Agrawal , Jungmin 2 2 2 2 1 Oh , Megan Donaldson , Alfred Schultz , Timothy Frank , Andreas Bommarius , Yoshiaki 1 1 2 Kawajiri , Georgia Institute of Technology, Atlanta, GA, USA; The Dow Chemical Company, Midland, MI, USA 4:20 PM Size-exclusion Simulated Moving Bed for Separating Organophosphorous Flame Retardants from a Polymer. George Weeden Jr., Lei Ling, Nicholas Soepriatna, Nien-Hwa Linda Wang, Purdue University, West Lafayette, IN, USA 4:40-4:50 PM Pause PREP 2015 Preliminary Scientific Program Page 10 8B. Tuesday Parallel Session: Bioprocess Chromatography Session Chair: Andre Dumetz, GlaxoSmithKline, King of Prussia, PA, USA 3:20 PM Column Simulation Approach to Understanding High Throughput Miniature Chromatography Column System Differences and Their Effects on Process Performance. 1 2 2 2 1 1 William Keller , Steven Evans , Gisela Ferreira , David Robbins , Steven Cramer , Rensselaer 2 Polytechnic Institute, Troy, NY, USA; MedImmune, Gaithersburg, MD, USA 3:40 PM Protein Size and Glycosylation Heterogeneity in Chromatographic Separation. Alan Shupe, Zhijun Tan, Xuankuo Xu, Chao Huang, Mi Jin, Yi Li, Biologics Development Global Manufacturing and Supply, Bristol-Myers Squibb Company, Hopkinton, MA, USA 4:00 PM Preparative Separation and Characterization of Immunoglobulin G Charge 1 1 2 3 Variants. Beate Hintersteiner , Nico Lingg , Zhang Peiqing , Manfred Schuster , Alois 1 1 Jungbauer , University of Natural Resources and Life Sciences Vienna, Vienna, AUSTRIA; 2 3 Bioprocessing Technology Institute, Singapore, SINGAPORE; Apeiron Biologics, Vienna, AUSTRIA 4:20 PM Efficient Sanitization of Affinity Chromatography Media using Novel Sanitization Agents. Elin Monie, Anna Grönberg, Anders Ljunglöf, Magnus Wetterhall, Tomas Björkman, GE Healthcare, Uppsala, SWEDEN 4:40-4:50 PM Pause 9A. Tuesday Parallel Session: Continuous Chromatography II Session Chairs: Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA, and Jose Paulo Mota, FCT/UNL & IBET, Caparica, PORTUGAL 4:50 PM Continuous Chromatography in Industrial Biotechnologies. Eric Valery, Benjamin Boissier, NovaSep, Lyon, FRANCE 5:10 PM Removal of Aggregates from Protein A Purified Monoclonal Antibody by Multicolumn Continuous Hydroxyapatite Chromatography. Anthony Grabski, Tom VanOosbree, Beth Hammer, Alla Zilberman, Robert Mierendorf, Semba Biosciences Inc., Madison, WI, USA 5:30 PM Robust Design of Adenovirus Purification by Two-column, Simulated Moving-bed, 1 1 1 Size-exclusion Chromatography. Piergiuseppe Nestola , Ricardo Silva , Cristina Peixoto , 1 2 1 2 Manuel Carrondo , Jose Mota , IBET, Oeiras, PORTUGAL; FCT/UNL & IBET, Caparica, PORTUGAL 5:50 PM Countercurrent Tangential Chromatography for Continuous Monoclonal Antibody 1 2 2 2 2 Purification. Andrew Zydney , Oleg Shinkazh , Amit Dutta , Boris Napadensky , Travis Tran , 2 1 2 Achyuta Teella , Penn State, University Park, PA, USA; Chromatan, State College, PA, USA 6:10 PM Pause PREP 2015 Preliminary Scientific Program Page 11 9B. Tuesday Parallel Session: Chromatographic Theory Session Chair: Attila Felinger, University of Pecs, Pecs, HUNGARY 4:50 PM Equilibrium Theory Solution of a System Subject to a Mixed Competitivecooperative Bi-langmuir Isotherm. Franziska Ortner, Simon Jermann, Marco Mazzotti, ETH Zurich, Zurich, SWITZERLAND 5:10 PM The Curious Case of the Delta Shock. Simon Jermann , Franziska Ortner , Marco 1 2 1 2 Mazzotti , Arvind Rajendran , ETH Zurich, Zurich, SWITZERLAND; University of Alberta, Edmonton, CANADA 5:30 PM Ligand-assisted Displacement Chromatography for Lanthanide Separations. Lei Ling, George Weeden Jr., Hoon Choi, N.-H. Linda Wang, Purdue University, West Lafayette, IN, USA 5:50 PM Getting More from Your Chromatograms. David Pfister, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND 6:10 PM Pause 1 PREP 2015 Preliminary Scientific Program 1 Page 12 Wednesday, July 29, 2015 7:15 AM Symposium Registration Open 10. Wednesday Keynote sponsored by Phenomenex: Process Scale Purification of Peptides and Oligonucleotides Session Chairs: Marc Jacob, Phenomenex, Torrance, CA, USA, and Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA 8:00 AM Complex Peptide Pharmaceuticals: Purification and Chromatography Strategies. Gary Erickson, CBL Biopharma LLC, Boulder, CO, USA 8:20 AM Peptide Purification: One Size Does Not Fit All. Steven McIntyre, Alastair Hay, Almac Group Ltd., Craigavon, UK 8:40 AM Analysis and Preparative Purification of Various Modified 21-mer RNA Oligonucleotides in Support of siRNA Drug Development. Mirlinda Biba, Merck, Rahway, NJ, USA 9:00 AM Process Scale Purification of Peptides. J. J. Jiang, Chunlian Qu, Emilio Gaeta, C S Bio Co., Menlo Park, CA, USA 9:20-9:50 AM Break 11. Wednesday Session: Chromatography for Large Biomolecule Purification Session Chair: David Roush, Merck & Co., Inc., Kenilworth, NJ, USA 9:50 AM Preparative High Resolution Separation of VLPs Variants. Petra Steppert, Daniel Burgstaller, Alois Jungbauer, BOKU, Vienna, AUSTRIA 10:10 AM Purification of Virus-like Particles: Downstream Process Development for a 1 2 3 Candidate Hepatitis C Vaccine. Ricardo Silva , Alex Xenopoulos , Andreas Stein , Ana 4 4 4 5 1 Coroadinha , Cristina Peixoto , Paula Alves , Manuel Carrondo , iBET, Oeiras, PORTUGAL; 2 3 4 EMD Millipore, Bedford, MA, USA; Merck KGaA, Darmstadt, GERMANY; iBET | ITQB-UNL, 5 Oeiras, PORTUGAL; iBET | ITQB-UNL | FCT-UNL, Oeiras, PORTUGAL 10:30 AM Establishment of a High-throughput Platform for the Production of Virus-like 1 1 1 Particles in E. coli. Pascal Baumann , Christopher Ladd Effio , Claudia Weigel , Philipp 1 2 1 1 1 Vormittag , Anton Middelberg , Stefan Oelmeier , Juergen Hubbuch , Karlsruhe Institute of 2 Technology (KIT), Karlsruhe, GERMANY; University of Queensland, Brisbane, AUSTRALIA 10:50 AM Purification of Plasmid DNA using Methacrylate Monolith Bearing Combination of 1 2 1 Ion-exchange and Hydrophobic Groups. Ales Podgornik , Vida Smrekar , FKKT, Ljubljana, 2 SLOVENIA; Ampliphi d.o.o., Ljubljana, SLOVENIA PREP 2015 Preliminary Scientific Program Page 13 12. Wednesday Session: Monoliths and Membrane Chromatography Session Chair: Abraham Lenhoff, University of Delaware, Newark, DE, USA 11:10 AM High Capacity Ion Exchange Membranes – Experimental and Theoretical Studies. Jerald Rasmussen, Cathy Bothof, Semra Colak, Robert Fitzsimons, George Griesgraber, Hongying Jiang, Richard Ross, 3M, St. Paul, MN, USA 11:30 AM Membrane Filtration Can Substitute Chromatographic Purification Steps for Plant1 derived and ELP-tagged Biopharmaceutical Proteins. Johannes Buyel , Patrick 2 2 2 1 Opdensteinen , Hannah Gruchow , Rainer Fischer , RWTH Aachen University, Aachen, 2 GERMANY; Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Aachen, GERMANY 11:50 AM Novel Perfusion Media of Pulverized Monolithic Silica Enabling High Performance 1 2 with Low Pressure in Peptide and Protein Separation. Hongzhi Bai , Mika Watanabe , 2 2 1 3 1 Teruhiko Kanno , Takeshi Ohtani , Riichi Miyamoto , Kazuki Nakanishi , SnG Inc., Kyoto, 2 3 JAPAN; Hamari Chemicals Ltd., Osaka, JAPAN; Kyoto University, Kyoto, JAPAN 12:10 PM Productivity and Economic Advantages of Coupling Single-pass Tangential Flow Filtration to Multi-column Chromatography for Continuous Processing. Karl Rogler, Xhorxhi Gjoka, Alexander Martino, Engin Ayturk, Rene Gantier, Mark Schofield, Pall Life Sciences, Westborough, MA, USA Presentation of Awards to Winners of the Best Poster Competition 12:30-12:40 PM 12:40-2:00 PM Lunch on own 13. Wednesday Session: Supercritical Fluid Chromatography (SFC) Session Chair: Lois Ann Beaver, LAB Enterprises, Chevy Chase, MD, USA 2:00 PM Analytical and Preparative SFC Can be Used as Powerful Tools in the Trace Impurity Separation, Measurement, Isolation, and Structural Assignment Workflow. John 1 2 1 2 McCauley , Marian Twohig , Waters SFC, New Castle, DE, USA; Waters, Milford, MA, USA 2:20 PM Using SFC and Polysaccharide Stationary Phases for Fast and Effective Chiral Separation Screening with Conversion to Liquid Chromatography for Larger Scale 1 1 1 2 1 Separations. J. Preston , Julissa Fernandez , Michael McCoy , William Farrell , Phenomenex, 2 Torrance, CA, USA; Pfizer Global R&D, La Jolla, CA, USA 2:40 PM A Peak Inside Genentech's Purification Group to Support Small Molecules. Mengling Wong, Brent Murphy, Genentech Inc., South San Francisco, CA, USA 3:00 PM Guidelines for Reliable Scale-up Scale Up in Preparative Supercritical Fluid 1 1 1 1 Chromatography. Torgny Fornstedt , Martin Enmark , Dennis Asberg , Joergen Samuelsson , 2 1 Andrew Shalliker , Department of Engineering and Chemical Sciences Karlstad University, 2 Karlstad, SWEDEN; Australian Centre for Research on Separation Science School of Science and Health University of Western Sydney, Penrith, AUSTRALIA 3:20-3:40 Pause PREP 2015 Preliminary Scientific Program Page 14 14. Wednesday Session: Centrifugal Partition Chromatography / Counter Current Chromatography (CPC / CCC) Session Chair: Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA 3:40 PM Scale-up Rules in Centrifugal Partition Chromatography: Towards Industrial 1 1 2 2 1 Solutions. Luc Marchal , Alexis Kotland , Sebastien Chollet , Jean-Hugues Renault , Nantes 2 University, Saint Nazaire, FRANCE; Reims University, Reims, FRANCE 4:00 PM Process Intensification and Scale Up in pH-zone Refining Centrifugal Partition Chromatography: Case of the Purification of Key Materials in the Semi-synthesis of Anti1 2 3 2 Cancer Drugs. Sebastien Chollet , Claire Mairot , Loic Brabant , Alexis Kotland , Jean-Marie 3 3 3 1 2 1 Autret , Gilles Calmels , Catherine Diard , Jane Hubert , Luc Marchal , Jean-Hugues Renault , 1 2 3 URCA, Reims, FRANCE; University of Nantes, Saint-Nazaire, FRANCE; Pierre Fabre, Gaillac, FRANCE 4:20 PM Advances in the Automation of Method Development and Prep Purification in 1 2 2 Counter Current Chromatography (CCC). Gary Yanik , Leo Hsu , Xiqin Yang , Dave 2 1 2 Thornton , PDR-Separations.com, Palm Beach Gardens, FL, USA; GSK, King of Prussia, PA, USA 4:40 PM Automated Method Development and Scale-up of Countercurrent Chromatography 1 1 2 1 1 at GSK. David Thornton , Xiqin Yang , Gary Yanik , Leo Hsu , GlaxoSmithKline, King of 2 Prussia, PA, USA; PDR Separations, Palm Beach Gardens, FL, USA 5:00-5:10 PM Pause 15. Wednesday Session: Manufacturability and Integration for Enhanced Bioprocess Chromatography Session Chair: Ales Podgornik, University of Ljubljana and COBIK, Ljubljana, SLOVENIA 5:10 PM Development of an Automated Manufacturability Assessment for Rational Selection of Platform-ready Monoclonal Antibodies, Bispecifics and Fc-Fusion Proteins. Neil Birkett, Alaa Abdel Latif, Richard Turner, MedImmune Ltd., Cambridge, UK 5:30 PM High-throughput Process Development for the Masses: Expanding the Usability of Mini-column Liquid Handler Systems through Improved User Interface and Enhanced 1 2 1 System Capabilities. Sethu Siva , Daniel Leach , Biogen Idec, Research Triangle Park, NC, 2 USA; Tecan US, Morrisville, NC, USA 5:50 PM Single Column “Recycle Chromatography” – A Simpler Alternative to Continuous Chromatography? Natraj Ram, M Herigstad, Lihua Yang, Wen Lim, Tia Bibas, Linda Rich, Hong Yang, AbbVie, Worcester, MA, USA 6:10 PM CLOSING REMARKS, Giorgio Carta, University of Virginia, Charlottesville, VA, USA 6:30-7:30 PM Farewell Reception (PREP & ISPPP shared reception in ISPPP Exhibit/Poster Hall) ** Submit New Poster Abstracts by June 15 ** Researchers with new results in areas relevant to the meeting topics are encouraged to submit abstracts online (up to approximately 400 words) for poster consideration. We are striving to ensure the broadest possible coverage and exchange of recent advances. For details, please visit www.PREPsymposium.org. Your abstract will be included in the preliminary list of posters as soon as accepted. Please see the Preliminary List of Poster Presentations on the following pages. Please submit online by June 15. Continue to the next pages listing the poster presentations, free vendor workshops, and preliminary list of sponsors, exhibitors and media partners PREP 2015 Preliminary Scientific Program Page 15 PREP 2015 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines Abstracts for poster presentation may be submitted online through June 15th Minor Whey Proteins Separation using Cation Exchange Chromatography. Naeimeh Faraji, Ajay K. Ray, Western University, London, CANADA Development of an Integrated Semi-preparative System for the Purification of Bioactive Phytochemicals. Mauricio Rostagno, School of Applied Sciences (FCA) University of Campinas (UNICAMP), Limeira, BRAZIL Chiral Separation of Citalopram by Simulated Moving Bed. Chih-Hsiung Lin , Ming-Tsai Liang , Jau1 2 1 2 Yann Wu , Ru-Chien Liang , I-Shou University, Kaohsiung, TAIWAN; JOPE Technology Co, Kaohsiung, TAIWAN Novel Purification Application of Capto(TM)Core700 Chromatography Media. Sheng-Ching Wang , 2 1 1 2 1 1 Anders Ljunglöf , Misha Varma , Marc Wenger , John Daicic , Michael A. Winters , Vaccine BioProcess 2 Research and Development Merck & Co., West Point, PA, USA; GE Healthcare Bio-Sciences AB, Uppsala, SWEDEN Integrated Process for High Yield and High Conversion Protein PEGylation. David Pfister, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND Comparison of Multi-column Continuous Protein A Capture Processes by Simulation and 1 1 2 1 Optimization. Daniel Baur , Monica Angarita , Thomas Mueller-Spaeth , Fabian Steinebach , Massimo 1 1 2 Morbidelli , ETH Zurich, Zurich, SWITZERLAND; ChromaCon AG, Zurich, SWITZERLAND Combined Approach for Quick and Easy Design of a Chromatographic Polishing Step. Rushd Khalaf , 2 2 2 3 1 Julia Heymann , Matteo Costioli , Florence Monard , Massimo Morbidelli , Institute for Chemical and Bioengineering Department of Chemistry and Applied Biosciences ETH Zurich, Zurich, SWITZERLAND; 2 3 Merck Serono S.A., Zurich, SWITZERLAND; ETH Zurich, Zurich, Switzerland Combination of Solvent and Mobile Phase Gradient to Improve Performance of Carousel Multicolumn Setup. Rafal Gorczyca, Roman Bochenek, Wojciech Marek, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND Evaluating Optima for Pseudo-ternary Separations in Simulated Moving Bed Chromatography. 1 2 3 1 Francisco Vitor Santos Da Silva , Bettina Kattein , Andreas Seidel-Morgenstern , Max Planck Institute for 2 Dynamics of Complex Technical Systems, Magdeburg, GERMANY; Technical University Braunschweig, 3 Braunschweig, GERMANY; Otto von Guericke University Magdeburg, Magdeburg, GERMANY Assessment of the Protein A Design Space for a MAb, Comparison of Traditional and HTS Data. Isha Chowdhary, Gregory Barker, Joseph Calzada, Joanne Rivera, Sibylle Herzer, Siegfried Rieble, Bristol-Myers Squibb, Bloomsbury, NJ, USA Comparing Definitive Screening Design to Traditional Experimental Designs for Hydrophobic 1 2 3 3 Interaction Chromatography Optimization. Lily Tsang , Kedar Dave , Joseph Calzada , Gregory Barker , 4 4 4 1 2 Michael Borys , Zhengjian Li , Yi Li , Bristol-Myers and Squibb, Seattle, WA, USA; Bristol-Myers and 3 4 Squibb, East Syracuse, NY, USA; Bristol-Myers and Squibb, Bloomsbury, NJ, USA; Bristol-Myers and Squibb, Hopkinton, MA, USA Protein Throughput and Yield Characteristics for Capillary-Channeled Polymer (C-CP) Fibers Phases with Emphasis on the Protein A/IgG System. R. Kenneth Marcus, Hung K. Trang, Abby J. SchadockHewitt, Clemson University, Clemson, SC, USA 1 1 1 1 PREP 2015 Preliminary Scientific Program Page 16 PREP 2015 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines Abstracts for poster presentation may be submitted online through June 15th HPLC Analysis of Polyphenols Contents in Various Natural Yemeni Honeys using Multiwalled Carbon Nanotubes as Solid Phase Extraction Adsorbent. Zeid Alothman, Saikh Wabaidur, King Saud University, Riyadh, KINGDOM OF SAUDI ARABIA High Performance Size Exclusion Chromatography of Virus-like Particles. Petra Steppert, Daniel Burgstaller, Alois Jungbauer, BOKU, Vienna, AUSTRIA Novel PAT Approach Employing UV Peak Area Based Collection for Chromatography Processes. M. Omon Herigstad, Lihua Yang, Jason Harding, Natarajan Ramasubramanyan, Abbvie Bioresearch Center Inc., Worcester, MA, USA Purification Platform Challenges and Strategies to Handle ”Tricky” Mabs. Anna Gronberg, Lena Karf, Kristina Nilsson Valimaa, Charlotte Brink, Anna Edman Orlefors, Mats Gruvegard, GE Healthcare Life Sciences, Uppsala, SWEDEN Parameter-free Mechanistic Prediction of Saturation Capacity in Ion Exchange Chromatography. Fabian Steinebach, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND Adsorption Model for Charge Isoforms of Monoclonal Antibodies. Fabian Steinebach, David Pfister, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND Fundamental Studies of Liquid Chromatography under Cryogenic Conditions. Gorgi Pavlov, James T. Hsu, Lehigh University, Bethlehem, PA, USA A Comparison of Multimodal Chromatographic Resins: Protein Binding and Selectivity. Leslie Wolfe, Eric Suda, Carnley Norman, Abhinav Shukla, KBI Biopharma, Durham, NC, USA Determinants of Protein Elution Rates from Preparative Ion-exchange Adsorbents. James Angelo, Abraham Lenhoff, University of Delaware, Newark, DE, USA Affinity Capture of F(ab)2 Fragments by Twin-column Counter-current Chromatography. Nicole 1 2 2 3 2 Ulmer , Thomas Mueller-Spaeth , Lars Aumann , Benjamin Neunstoecklin , Michael Bavand , Massimo 1 1 2 3 Morbidelli , ETH Zurich, Zurich, SWITZERLAND; ChromaCon AG, Zurich, SWITZERLAND; Novartis Pharma AG, Basel, SWITZERLAND Design and Optimization of an Integrated SMB-crystallization Process using a Binary Solvent. 1 1 2 1 1 1 Balamurali Sreedhar , Huayu Li , Baochun Shen , Ronald Rousseau , Yoshiaki Kawajiri , Georgia Institute 2 of Technology, Atlanta, GA, USA; Kunming Medical University, Kunming, CHINA Simplifying Continuous Capture Chromatography Process Development - Optimization of Process Parameters to fit Business Need. Xhorxhi Gjoka, Karl Rogler, Richard Martino, Rob Noel, Rene Gantier, Mark Schofield, Pall Corporation, Westborough, MA, USA Adsorptive Removal of Nitrate from Aqueous Phase using De-Acidite FF-IP Resin: Determination by 1 1 Ultra-performance Liquid Chromatography-mass Spectrometry. Zeid Alothman , Mu. Naushad , Moonis 2 2 1 Khan , Mohammad Khan , Advanced Materials Research Chair Department of Chemistry College of Science, King Saud University, Riyadh, KINGDOM OF SAUDI ARABIA PREP 2015 Preliminary Scientific Program Page 17 PREP 2015 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines Abstracts for poster presentation may be submitted online through June 15th Automated Chiral Method Development and Semi Prep Scale Up on a Single HPLC Instrument. Todd Anderson, Shimadzu Scientific, Columbia, MD, USA QSPR Modeling of Protein Melting Curve Parameters for a Diverse Set of Polyhydric Alcohols. Olubukayo Oyetayo, Hans Kiefer, Institute of Applied Biotechnology Biberach University of Applied Sciences, Biberach Riss, GERMANY Isolation of Impurities in Celestone (MK-4831, Betamethasone Oral Solution). Fuh-Rong Tsay, Luz Kachar, Gary Martin, Ingrid Mergelsberg, Wes Schafer, Weidong Tong, Heather Wang, Wendy Zhong, Merck & Co. Inc., Rahway, NJ, USA Size-exclusion Simulated Moving Bed: Solvent Consumption and Sorbent Productivity Related to Material Properties and Design Parameters. George Weeden Jr., Nien-Hwa Linda Wang, Purdue University, West Lafayette, IN, USA Parameter Estimation and Online Column Qualification for Protein A Chromatography in MATLAB for Monoclonal Antibody Purification. Ketki Behere, Seongkyu Yoon, University of Massachusetts Lowell, Lowell, MA, USA Significance of Sample Preparation on Primary and Secondary Metabolite Analysis of Dry Beans. Devanand Luthria, K. M. Maria John, US Department of Agriculture, Beltsville, MD, USA Effects of Line Defects in Porous Media Studied through 3D Printing. Conan Fee, Suhas Nawada, Simone Dimartino, University of Canterbury, Christchurch, NEW ZEALAND Improving Recovery of Recombinant Hepatitis B Virus Surface Antigen by Ion Exchange Chromatography with Changing Salt Concentration in Buffer. Maryam Khatami, Seyyednezamedin Hosseini, Golmohamad Mojarad-Moghanloo, Pasteur Institute of Iran, Tehran, IRAN A Rational Design Strategy for Continuous Chromatography Processes throughout the Product Life Cycle. Marc Bisschops, Tarpon Biosystems Europe BV, Leiden, THE NETHERLANDS Recovery of High Value Buffer via Size Exclusion Chromatography in r-HBsAg Production Process. 1 2 2 1 1 Seyed Nezamedin Hosseini , Davod Rezaei , Seyed Siamak Ashraf , Maryam Khatami , Production & 2 Research Complex Pasteur Institute of Iran, Tehran, IRAN; Department of Chemical Engineering, Guilan University, Guilan, IRAN SMB Online Detection with Principal Component Analysis for Achiral Separations. Xiqin Yang , Gary 2 2 1 1 2 Yanik , Necmi Bugdayci , Leo Hsu , GlaxoSmithKline, King of Prussia, PA, USA; PDR-Separations, Palm Beach Gardens, FL, USA Development of a Chromatography Step using a Mixed-mode Resin for the Removal of Reduced Monoclonal Antibody Fragments. Nathaniel Macapagal, Kelcy Newell, MedImmune, Gaithersburg, MD, USA Understanding and Enhancing Selectivity in Multimodal Chromatography through Ligand Design and Biophysics. Steven Cramer, Rensselaer Polytechnic Institute, Troy, NY, USA Production and Purification of Hepatitis B Core Antigen Chimeric Proteins in a Novel Vaccination Strategy Against Porcine Epidemic Diarrhea Virus. Frank Gillam, Mike Zhang, Virginia Tech, Blacksburg, VA, USA 1 PREP 2015 Preliminary Scientific Program Page 18 PREP 2015 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines Abstracts for poster presentation may be submitted online through June 15th Application of High Throughput Resin Tips for Chromatography Development. Michael Rauscher, John Welsh, Jennifer Pollard, Merck & Co. Inc., Kenilworth, NJ, USA Fast Centrifugal Partitioning Chromatography. Robert Driscoll, Rubotherm, Pittsfield, MA, USA Analytical and Preparative SFC Can be Used as Powerful Tools in the Trace Impurity Separation, 1 2 Measurement, Isolation, and Structural Assignment Workflow. John McCauley , Marian Twohig , 1 2 Waters SFC, New Castle, DE, USA; Waters, Milford, MA, USA High Capacity Ion Exchange Membranes – Experimental and Theoretical Studies. Jerald Rasmussen, Cathy Bothof, Semra Colak, Robert Fitzsimons, George Griesgraber, Hongying Jiang, Richard Ross, 3M, St. Paul, MN, USA Equilibrium Theory Solution of a System Subject to a Mixed Competitive-Cooperative Bi-Langmuir Isotherm. Franziska Ortner, Simon Jermann, Marco Mazzotti, ETH Zurich, Zurich, SWITZERLAND Development of an Automated Manufacturability Assessment for Rational Selection of Platformready Monoclonal Antibodies, Bispecifics and Fc-Fusion Proteins. Neil Birkett, Alaa Abdel Latif, Richard Turner, MedImmune Ltd., Cambridge, UK Defining Operating Ranges for an Anion Exchange Chromatography Step While Controlling for Product-Related Variants. Trevor Wiley, Phillip Smith, Bruno Marques, Kent Göklen, GlaxoSmithKline, King of Prussia, PA, USA Extending the Potential of Moment Analysis in Chromatography. Shamsul Qamar, Andreas SeidelMorgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY Molecular Dynamics as a Stepping Stone for Advanced Chromatography Modeling. Anna Osberghaus, Katharina Lang, Florian Pilgram, Juergen Hubbuch, Karlsruhe Institute of Technology, Karlsruhe, GERMANY Establishment of a High-throughput Platform for the Production of Virus-like Particles in E. coli. 1 1 1 1 2 Pascal Baumann , Christopher Ladd Effio , Claudia Weigel , Philipp Vormittag , Anton Middelberg , Stefan 1 1 2 Oelmeier , Juergen Hubbuch, Karlsruhe Institute of Technology (KIT), Karlsruhe, GERMANY; University of Queensland, Brisbane, AUSTRALIA Evaluating Integrity Breach of Preparative Columns (A Study on Q Sepharose Resin). Shaun Grier, Saani Yakubu, Shire, Lexington, MA, USA Development of a cGMP-like Purification Process for Adenovirus Purification. Mark Snyder, Randy Jacinto, Bio-Rad Laboratories, Hercules, CA, USA Development of a 2-Dimensional HPLC System to Improve Outcomes of Chiral Purification in Drug Discovery Laboratories. Lisa Schaffter, Sopheary Op, Abbvie Bioresearch Center, Worcester, MA, USA Capture of Biomolecules: Is Affinity Chromatography Always Best? Mark Lankford, Liese BeenkenRothkopf, Yaling Wu, Bruno Marques, Kent Goklen, GlaxoSmithKline, King of Prussia, PA Hydrophobic Interaction Chromatography Resin Fouling During Monoclonal Antibody Purification. Theodore Diakov, Steven Traylor, Jie Chen, Yi Li, ZhengJian Li, Bristol-Myers-Squibb, Hopkinton, MA, USA PREP 2015 Preliminary Scientific Program Page 19 PREP 2015 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines Abstracts for poster presentation may be submitted online through June 15th Characterization of Column Performance in Downstream Protein Purification: Comparison of Different Experimental Techniques. Christopher Gerberich, André Dumetz, Gerald Terfloth, GlaxoSmithKline, King of Prussia, PA, USA Enhancing Hydrolytic Stability of Bonded Phases: Pendant Dipodal Silanes. Barry Arkles, Alison Sikorsky, Craig Smith, Gelest Inc., Morrisville, PA, USA Adsorption Equilibrium and Kinetics of Monomer-Dimer Monoclonal Antibody Mixtures on a Cation 1 2 2 2 1 Exchange Resin. Jason Reck , Timothy Pabst , Alan Hunter , Xiangyang Wang , Giorgio Carta , 1 2 University of Virginia, Charlottesville, VA, USA; MedImmune, Gaithersburg, MD, USA Optimization of Dispersive Liquid–Liquid Microextraction Coupled with Gas ChromatographyNegative Ion Chemical Ionization Mass Spectrometry for the Determination of Pyrethroids in Agricultural Products. Yu Chieh Wang, Jia Lin Wang, Youn Yuen Shu, National Kaohsiung Normal University, Kaohsiung, TAIWAN Advanced Analytical Technologies in BioProcess Development: Applications of Online UPLC, TwoDimensional LC, and QC-Friendly Mass Spectrometry Detector. Zhi Chen, Douglas Richardson, Jennifer Pollard, Collette Cutler, William Rayfield, InKwan Han, Patricia Rowicki, Nihal Tugcu, William Napoli, David Pollard, Daisy Richardson, Mohammed Shameem, Merck Research Laboratories, Kenilworth, NJ, USA Purification of Chlorogenic Acid from Green Coffee using Kinetex Core-shell Technology in Axia Preparative Format. Marc Jacob, Zeshan Aqeel, J. Preston, Jeff Layne, Phenomenex, Torrance, CA, USA Water as Additive in a Generic SFC Method used in Preparative Scale. Pernilla Korsgren, Annika Langborg Weinmann, Hanna Leek, Johanna Malm, RIA iMed, AstraZeneca R&D, Molndal, Sweden, Kristina Öhlen, RIA iMed, AstraZeneca R&D, Molndal, SWEDEN HMW Control in Large-Scale Manufacturing of Biologics. Nuria de Mas , Andrew Lee , Aayush Pandey , 1 1 2 3 1 4 Sivaprakash Agastin , Danielle Harrison , Kedar Dave , Joseph Shiminsky , Itzcoatl Pla , Joseph Calzada , 4 4 4 1 Gregory Barker , Sibylle Herzer , Siegfried Rieble , Bristol-Myers Squibb, Manufacturing Sciences & 2 Technology, Hopkinton, MA, USA; Bristol-Myers Squibb, Manufacturing Sciences & Technology, East 3 4 Syracuse, NY, USA; Bristol-Myers Squibb, Manufacturing Technology, Devens, MA, USA; Bristol-Myers Squibb, Process Development, Bloomsbury, NJ, USA Hydrophobic Interaction Process Scale Separation of Protein, mAb and Antibody Drug Conjugate. Sixi Wang, Haiying Chen, Xueying Huang, Ke Yang, Sepax Technologies, Newark, DE, USA Process Design Method for Capture Chromatography based on a Simplified Mechanistic Model. 1 1 1 2 1 Noriko Yoshimoto , Yu Isakari , Shuichi Yamamoto , Ales Podgornik , Yamaguchi University, Ube, JAPAN; 2 University of Ljubljana and COBIK, Ljubljana, SLOVENIA Purification of Conjugated Glucose-Responsive Insulin with a Single Chromatographic Process. 1 2 1 1 1 2 Haiying Bao , Kevin Maloney , Nihal Tugcu , Sunitha Kandula , Merck, Kenilworth, NJ, USA; Merck, Rahway, NJ, USA Novel Functional Ion Exchanger with Sulfate Group. Kosuke Araki, Koji Nakamura, Shigeru Nakatani, Tosoh Corporation, Shunan, JAPAN 1 PREP 2015 Preliminary Scientific Program 1 1 Page 20 PREP 2015 Preliminary List of Poster Presentations Poster Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines Abstracts for poster presentation may be submitted online through June 15th Systematic Interpolation Method to Predict Protein Elution based on HTS Isotherm Data. Arch 1 2 2 1 1 Creasy , Gregory Barker , Yan Yao , Giorgio Carta , University of Virginia, Charlottesville, VA, USA; 2 Bristol-Myers Squibb, Hopewell, NJ, USA Avoiding a Lifetime of Problems: Overcoming Fouling and Bed Integrity Issues During Small-Scale 1 2 2 2 Chromatography Cycling Studies. Andrew Pike , Phillip Smith , Bruno Marques , Kent Göklen , 1 2 Biopharm CMC, Philadelphia, PA, USA; GlaxoSmithKline, King of Prussia, PA, USA Continue to the next pages listing the free vendor workshops and the preliminary list of sponsors, exhibitors and media partners PREP 2015 Preliminary Scientific Program Page 21 Free Vendor Workshops Monday PUROLITE Vendor Workshop at 12:45-2:00pm "Praesto, A New Range of High Performance Agarose Resins Designed for Large Scale Protein Purification" Presented by: Hans J. Johansson, Purolite With the continuing development of high titer cell lines, resins combining high capacity with excellent pressure/flow properties are becoming increasingly important. This workshop will present application and characterization data from a set of novel, high capacity resins, with ion exchange functionality as well as with immobilized, alkaline stable, Protein A. The cation exchanger has a dynamic binding capacity of more than 120 mg monoclonal antibody/ml resin without the introduction of surface extenders. Performance data from Protein A resins with dynamic binding capacities over 60 mg/ml will also be shown. You may pre-register by contacting: [email protected] Monday MITSUBISHI CHEMICAL CORPORATION Vendor Workshop at 12:45-2:00pm "Bioseparation Media" Presented by: Mayumi Kiyono and Tim O'Mara, Mitsubishi Chemical Corporation 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 seminar is to introduce these products designed for high throughput processing. Please direct all inquiries related to the workshop to: [email protected] Tuesday THERMO FISHER SCIENTIFIC Vendor Workshop at 6:30-8:00AM TBA Tuesday AKZONOBEL Vendor Workshop at 12:45-2:00pm "Advances in the Development of Stationary Phases for Preparative Chromatography" Presented by: Fredrik Lime and Cecilia Mazza This workshop will present Kromasil EternityXT, a material 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 as pre-packed columns provides users with the opportunity to run under tough pH conditions and higher temperatures across discovery, development and production stages. The material’s resistance to high alkaline concentrations for regeneration in-column will also be discussed. Examples will be shown of the increased flexibility that allows users to work with a pH window from 1 to 12. Tuesday LEWA Vendor Workshop at 12:45-2:00pm "New LPLC Pilot and Production Platform with Buffer In Line Capability" Presented by: Gary Gaudet, Global Product Manager, LEWA Corporation The first newly engineered standard LPLC platform to come to market in years leverages the latest fluid dynamic engineering science, state of the art componentry/sensors and features over 15 optional system enhancements. A walk through of design philosophy and rational of process design at each major feature of the new EcoPrime LPLC will be offered in the Workshop. The platform stands unique incorporating on-board buffer-in-line dilution with servo controlled diaphragm pumps which provide significant improvement in gradient accuracy, flow range and mixing precision. The presenters will also give a peek into the future of how this platform will be the basis for continuous chromatography in the not-too-distant future. Please direct all inquiries related to the workshop to: [email protected] PREP 2015 Preliminary Scientific Program Page 22 Sponsors, Exhibitors, Media Partners at-a-glance Ace Glass Agilent Technologies AkzoNobel/Kromasil American Elements American Laboratory American Pharmaceutical Review Ampac Fine Chemicals Analytical Scientist BioProcessing Journal Buchi Chromatography Today/International LabMate ChromWorks DAISO Fine Chem USA Essential Life Solutions Genentech Genetic Engineering News GlaxoSmithKline Graver Technologies Innovations in Pharmaceutical Science Kaneka Americas Holding Knauer Lab Bulletin Lab Manager LCGC LEWA-Nikkiso America MedImmune Merck Mitsubishi Chemical Corporation NOVASEP Pfizer Pharmaceutical Outsourcing Phenomenex Purolite Semba Biosciences Separation Science Shire SP Scientific-Genevac Thermo Fisher Scientific Tosoh Bioscience Waters Corporation YMC America PREP 2015 Preliminary Scientific Program Page 23 PREP 2015 Preliminary Scientific Program Page 24
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