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PREP 2015 Preliminary Scientific Program Page 1

—PREP 2015 Scientific Program— (program as of 7/24/2015)

Message from the PREP 2015 Organizing Committee We welcome you to PREP 2015, the 28th International Symposium, Exhibit & Workshops on Preparative and Process Chromatography. PREP 2015 continues the tradition of driving scientific progress with an exciting technical program, providing in-depth technical education & training with an extensive workshop program, and showcasing the latest commercial technology with a vibrant exhibit. The Scientific Program includes 74 oral presentations and 95 posters addressing the most recent developments in preparative chromatography from the gram scale to the multiple ton scale for both small molecules and biomolecules. The oral program includes: keynote sessions on Industrial Protein Chromatography (2), Preparative chromatography for Medicinal Chemistry, Drug Discovery & Development (5), Process Scale Purification of Peptides and Oligonucleotides (10); plenary sessions on Understanding and Modeling Biomolecular Interactions in Chromatographic Purification (6), Innovative Chromatographic Materials (7), Chromatography for Large Biomolecule Purification (11), Monoliths and Membrane Chromatography (12), Supercritical Fluid Chromatography (13), CPC/CCC (14), and Manufacturability and Integration for Enhanced Bioprocess Chromatography (15); and parallel sessions on Strategies and Processes for Biomolecule Purification, (3A), Process Modeling and Design (4A), Stationary Phases (3B and 4B) , Continuous Chromatography (8A and 9A), Bioprocess Chromatography (8B), and Chromatographic Theory (9B). Posters will be on display over a two-day period allowing you to interact extensively with the presenters. The Training Workshop Program led by a team of internationally renowned experts includes workshops on Preparative Chromatography for Biomolecule Purification, Preparative Chromatography for Purification of APIs, Continuous Chromatography for Biomolecule Purification, and Regulatory Fundamentals and QbD for Biopharmaceuticals. The Vendor Exhibit includes 26 booths through which you can become familiar with the latest commercial advances in preparative and process chromatography. Vendor Workshops sponsored by Mitsubishi, Purolite, Thermo Fisher Scientific, AkzoNobel, and LEWA-Nikkiso complement the exhibit with more extensive information. These workshops are free and include breakfast or lunch, but you must register in advance by visiting the vendor booth. We invite you to take advantage of all of these unique training and educational opportunities and to interact with vendors and providers of chromatography media, equipment, processes, and services. Unfortunately, PREP 2015 will be different in one important respect – Georges Guiochon, who started PREP thirty one years ago, is no longer with us. PREP 2015 recognizes his lifelong achievements and celebrates his legacy with a special keynote session in his memory. This session will include technical presentations by some of the very best people in the preparative chromatography field as well as reflections on Georges’ life presented by some of his former students and close associates. We welcome you to PREP 2015 where you will find that the talks, posters, exhibits, training and vendor workshops, discussions, and networking opportunities will help you solve today’s separation problems and better prepare you for the future of preparative chromatography. Giorgio Carta University of Virginia PREP 2015 Chair


PREP 2015

PREP 2015 Chair

Giorgio Carta, University of Virginia

Organizing Committee

Lois Ann Beaver, LAB Enterprises Giorgio Carta, University of Virginia (Chair) Olivier Dapremont, AMPAC Fine Chemicals

Larry Miller, Amgen Igor Quinones-Garcia, Shire

Scientific Advisory Committee Dorota Antos, Rzeszow University of Technology Steven Cramer, Rensselaer Polytechnic Institute Attila Felinger, University of Pecs, Hungary Ranga Godavarti, Pfizer Kent Goklen, GlaxoSmithKline Art Hewig, Amgen Alois Jungbauer, BOKU, Vienna Abraham Lenhoff, University of Delaware

Philip Lester, Genentech Massimo Morbidelli, ETH Zurich David Robbins, MedImmune David Roush, Merck & Co., Inc. Andreas Seidel-Morgenstern, Max-Planck Institute, Magdeburg Owen Thomas, University of Birmingham, UK Shuichi Yamamoto, Yamaguchi University, Japan

Industrial Advisory Committee

Marc Jacob, Phenomenex Mayumi Kiyono-Shimobe, Mitsubishi Karol Lacki, GE Healthcare Jiali Liao, Bio-Rad Laboratories Jurgen Machielse, Zeochem

Kathleen Mihlbachler, LEWA-Nikkiso Ernie Sobkow, YMC America Eric Valery, Novasep Alla Zilberman, Semba Bioscience

Poster Session Chairs

Arvind Rajendran, University of Alberta, Canada Owen Thomas, University of Birmingham, UK

Symposium / Exhibit Manager

Ms. Janet Cunningham, Barr Enterprises Phone 301-668-6001

[email protected] LinkedIn.com/in/BarrEnterprises

PREPsymposium.org

The use of still or video cameras and cell phones is prohibited during the oral program; and prohibited in the poster and exhibition areas without the express consent of the presenter or exhibitor. Opinions expressed by presenters,

instructors and exhibitors are not necessarily the opinions of the PREP 2015 Symposium.


Corporate Sponsors

Media Partners

Conference History

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1986 Washington DC 2003 San Francisco, CA

1987 Washington DC 2004 Baltimore, MD

1989 Washington DC 2005 Philadelphia, PA



1994 Washington DC 2008 San Jose, CA



1997 Washington DC 2011 Cambridge, MA

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1999 San Francisco, CA 2013 Boston, MA

2000 Washington DC 2014 Boston, MA


2001 Washington DC

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Sunday, July 26, 2015

Sign up Now for Workshop Offerings to Fast-track Your Knowledge

We invite you to take advantage of the unique training and educational opportunities offered in the Sunday Training Workshop Program. Dynamic presentations covering both fundamentals and applications will be presented by a team of internationally renowned experts. Certificates of completion recognizing attendance will be awarded. For details describing the workshops and costs, please see http://prepsymposium.org/workshop-sunday.html. You must pre-register to attend workshops; open to meeting and non-meeting attendees; workshop registration is in addition to the symposium registration fee.

9:00 AM - 12:30 PM Preparative Chromatography for Biomolecule Purification Workshop Commonwealth A1 Workshop 1 - Must pre-register to attend 9:00 AM - 12:30 PM Preparative Chromatography for Purification of APIs Workshop Commonwealth A2 Workshop 2 - Must pre-register to attend 1:30 PM - 4:30 PM Regulatory Fundamentals and QbD for Biopharmaceuticals Workshop Commonwealth A1 Workshop 4 - Must pre-register to attend 3:30 PM - 6:30 PM Continuous Chromatography for Biomolecule Purification Workshop Commonwealth A2 Workshop 3 - Must pre-register to attend

6:00 - 7:30 PM Symposium Registration Open, 2nd floor

6:00 - 7:30 PM Welcome Reception & Exhibition in Millennium Hall, 2nd floor

http://prepsymposium.org/workshop-sunday.html



EDUCATIONAL TRAINING WORKSHOP PROGRAM

Must pre-register online to attend workshops; open to meeting and non-meeting attendees

WORKSHOP 1 - Preparative Chromatography for Biomolecule Purification 9:00am - 12:30pm in Commonwealth A1, 2nd floor - Must pre-register to attend

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.






WORKSHOP 2 - Preparative Chromatography for Purification of APIs 9:00am - 12:30pm in Commonwealth A2, 2nd floor - Must pre-register to attend

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.






WORKSHOP 3 - Continuous Chromatography for Biomolecule Purification 3:30pm - 6:30pm in Commonwealth A2, 2nd floor - Must pre-register to attend

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.






WORKSHOP 4 - Regulatory Fundamentals and QbD for Biopharmaceuticals 1:30pm - 4:30pm in Commonwealth A1, 2nd floor - 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, 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.



Free Vendor Workshops on Monday [must pre-register at sponsor's booth]

12:45-2:00 PM Monday Free Vendor Workshop sponsored by Purolite "Praesto, A New Range of High Performance Agarose Resins Designed for Large Scale Protein Purification" Presented by: Hans J. Johansson, Purolite Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of Purolite by Monday @ 10:50 AM 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]

12:45-2:00 PM Monday Free Vendor Workshop sponsored by Mitsubishi Chemical Corporation

"Bioseparation Media" Presented by: Mayumi Kiyono and Tim O'Mara, Mitsubishi Chemical Corporation Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of Mitsubishi by Monday @ 10:50 AM 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]


Free Vendor Workshops on Tuesday [must pre-register at sponsor's booth]

7:00-8:00 AM Tuesday Free Vendor Workshop sponsored by Thermo Fisher Scientific "The Benefits of High Performing Chromatography Resins Including POROS XQ, A New Strong Anion Exchanger" Presented by: Jeanie Kim, Senior FAS, Bioproduction, Thermo Fisher Scientific Location: Commonwealth A1, 2nd floor (continental breakfast will be provided) Must pre-register at the booth of Thermo Fisher Scientific by Monday @ 5:00 PM

POROS resins offer unique performance attributes and drive benefits to downstream processing. POROS XQ is the newest addition to our product portfolio. This high capacity, salt tolerant, high resolution anion exchanger enables unique selectivity, higher product yields through better separation and reduced cost of goods. Applications data will be used to demonstrate the benefits of POROS resins to capture and polish chromatography and process modeling will be used to demonstrate cost of goods improvements and process efficiencies that can be realized.

12:45-2:00 PM Tuesday Free Vendor Workshop sponsored by AkzoNobel "Advances in the Development of Stationary Phases for Preparative Chromatography"

Presented by: Fredrik Lime and Cecilia Mazza Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of AkzoNobel by Monday @ 5:00 PM

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.

12:45-2:00 PM Tuesday Free Vendor Workshop sponsored by LEWA-Nikkiso America "New LPLC Pilot and Production Platform with Buffer In Line Capability"

Presented by: Gary Gaudet, Global Product Manager, LEWA Corporation Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of LEWA-Nikkiso America by Monday @ 5:00 PM

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]


Monday, July 27, 2015

7:15 AM Symposium Registration Open, 2nd floor

10:15 AM - 5:15 PM Exhibition Open in Millennium Hall, 2nd floor

8:00 AM Welcome and Opening Remarks Giorgio Carta, University of Virginia, Charlottesville, VA, USA Location: Commonwealth Hall B, 2nd floor

1. Monday Keynote sponsored by Elsevier, Journal of Chromatography A: In Memory of Georges Guiochon Session Chairs: Kathleen Milhbachler, LEWA-Nikkiso, Devens, MA, USA, and Igor Quinones-Garcia, Shire, Lexington, MA, USA Location: Commonwealth Hall B, 2nd floor

8:10 AM Opening Remarks 8:20 AM L-101 The Georgesian Optimization of Chromatography and Life. Attila Felinger,

University of Pecs, Pecs, HUNGARY 8:45 AM L-102 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 L-103 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 L-104 Combining Theory and Practice for a Deeper Understanding of the Separation

Process. Torgny Fornstedt, Karlstad University, Uppsala, SWEDEN 10:00 AM L-105 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, 2nd floor



2. Monday Keynote: Industrial Case Studies in Protein Chromatography Session Chair: Giorgio Carta, University of Virginia, Charlottesville, VA, USA Location: Commonwealth Hall B, 2nd floor

11:10 AM L-106 Engineering of Novel Protein A Ligands to Enable Milder Elution pH and High

Dynamic Binding Capacity. Timothy Pabst1, Ronnie Palmgren

2, Annika Forss

2, Jelena Vasic

2,

Mariko Fonseca1, Christopher Thompson

1, William Wang

1, Xiangyang Wang

1, Alan Hunter

1,

1MedImmune, Gaithersburg, MD, USA;

2GE Healthcare, Uppsala, SWEDEN

11:30 AM L-107 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 L-108 Integration of High Throughput Process Development with Empirical Modeling

Approaches. Gregory Barker1, Arch Creasy

2, Joseph Calzada

1, Nate Domagalski

1, Zheng

Ouyang1, Sibylle Herzer

1, Giorgio Carta

2, Siegfried Rieble

1,

1Bristol-Myers Squibb, Bloomsbury,

NJ, USA; 2University of Virginia, Charlottesville, VA, USA

12:10 PM L-109 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 Workshop sponsored by Purolite "Praesto, A New Range of High Performance Agarose Resins Designed for Large Scale Protein Purification" Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of Purolite by Monday @ 10:50 AM

12:45-2:00 PM Free Vendor Workshop sponsored by Mitsubishi Chemical Corporation "Bioseparation Media" Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of Mitsubishi by Monday @ 10:50 AM

POSTER SESSION I - sponsored by Bristol-Myers Squibb Poster Session Chairs: Arvind Rajendran, University of Alberta, CANADA, and Owen Thomas, University of Birmingham, UK

2:00-3:20 PM POSTER SESSION I - sponsored by Bristol-Myers Squibb Posters in the P-100 series will be presented on Monday in Poster Session I Location: Millennium Exhibit Hall, 2nd floor



3A. Monday Parallel Session: Strategies and Processes for Biomolecule Purification Session Chair: David Robbins, MedImmune, Gaithersburg, MD, USA Location: Commonwealth Hall C, 2nd floor

3:20 PM L-110 Flow-Through Chromatography. Turbocharged. Peter Gagnon, Richard Nian, Wei

Zhang, Hui Theng Gan, Bioprocessing Technology Institute, Singapore, SINGAPORE 3:40 PM L-111 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 L-112 Multicomponent Adsorption of GFP on Anion Exchange Resins. Rainer Hahn,

Sabine Necina, Bernhard Sissolak, BOKU, Vienna, AUSTRIA 4:20 PM L-113 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, 2nd floor

3B. Monday Parallel Session: Stationary Phases I Session Chair: Andreas Seidel-Morgenstern, Max Planck Institute, Magdeburg, GERMANY Location: Commonwealth Hall B, 2nd floor

3:20 PM L-114 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 L-115 Tracing the Trend of Increasing Productivity in Prep Chromatography with use of

Immobilized Polysaccharide Derived Chiral Stationary Phases. Joseph M. Barendt1, Mireille

Schaeffer2, David Robin

2, Pilar Franco

2, James Lee

1,

1Chiral Technologies, West Chester, PA,

USA; 2Chiral Technologies Europe, Illkirch, FRANCE

4:00 PM L-116 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 L-117 Design of Novel, Alkaline Stable, Protein A Resins. Hans J. Johansson, Hans Berg, Patrick Gilbert, Mark Hicks, Caroline Tinsley, Purolite, Llantrisant, UK

4:40-5:10 PM Break in Millennium Exhibit Hall, 2nd floor



4A. Monday Parallel Session: Process Modeling and Design Session Chair: Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND Location: Commonwealth Hall B, 2nd floor

5:10 PM L-118 Chromatographer: What Could Modeling Do for You? Roger-Marc Nicoud, Ypso-

Facto, Nancy, FRANCE 5:30 PM L-119 Process Design Method for Capture Chromatography based on a Simplified

Mechanistic Model. Noriko Yoshimoto1, Yu Isakari

1, Shuichi Yamamoto

1, Ales Podgornik

2,

1Yamaguchi University, Ube, JAPAN;

2University of Ljubljana and COBIK, Ljubljana, SLOVENIA

5:50-6:10 PM L-120 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 Location: Commonwealth Hall C, 2nd floor

5:10 AM L-121 MAb Aggregate Removal with a New Type of Anion Exchange Resin. Egbert

Mueller1, Patrick Endres

2, Judith Vajda

1,

1Tosoh Bioscience GmbH, Stuttgart, GERMANY;

2Tosoh Bioscience GmbH, Stuttgart, GERMANY

5:30 PM L-122 Purification Routes for New Antibody Formats and Non-mAb Proteins.

Carsten Voss, Bio-Rad Laboratories GmbH, Munich, Bavaria, GERMANY 5:50 PM L-123 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


Tuesday, July 28, 2015

7:00-8:00 AM Free Vendor Workshop sponsored by Thermo Fisher Scientific "The Benefits of High Performing Chromatography Resins Including POROS XQ, A New Strong Anion Exchanger" Location: Commonwealth A1, 2nd floor (continental breakfast will be provided) Must pre-register at the booth of Thermo Fisher Scientific by Monday @ 5:00 PM

7:15 AM Symposium Registration Open, 2nd floor

9:20 AM - 3:30 PM Exhibition Open in Millennium Hall, 2nd floor

5. Tuesday Keynote: Preparative Chromatography in Medicinal Chemistry, Drug Discovery and Development Session Chair: Larry Miller, Amgen, Cambridge, MA, USA Location: Commonwealth Hall B, 2nd floor

8:00 AM L-201 Integrated Purification Solutions for Medicinal Chemistry and High-Throughput

Synthesis In Pharmaceutical Discovery. Philip Searle, AbbVie Inc, North Chicago, IL, USA 8:20 AM L-202 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 L-203 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 L-204 Merck Automated Purification for Drug Discovery. Kuanchang Chen, Merck & Co.

Inc., Kenilworth, NJ, USA

9:20-9:50 AM Break in Millennium Exhibit Hall, 2nd floor

6. Tuesday Session: Understanding and Modeling Biomolecular Interactions in Chromatographic Purification Session 6: Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND Location: Commonwealth Hall B, 2nd floor

9:50 AM L-205 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 L-206 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 L-207 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 L-208 Solubility Pattern of Proteins in Overloaded Gradient Chromatography. Izabela

Poplewska, Michal Kolodziej, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND



7. Tuesday Session: Innovative Chromatographic Materials Session Chair: Alois Jungbauer, BOKU, Vienna, AUSTRIA Location: Commonwealth Hall B, 2nd floor

11:10 AM L-209 Magnetic Fishing Games - Seriously Attractive Separations. Owen Thomas

1, Alfred

Fernandez-Castane1, Tim Overton

1, Matthias Franzreb

2,

1University of Birmingham, Edgabston

Birmingham, UNITED KINGDOM; 2Karlsruhe Institute of Technology, Leopoldshafen Karlsruhe,

GERMANY 11:30 AM L-210 Effects of Line Defects in Porous Media Studied through 3D Printing. Conan Fee,

Suhas Nawada, Simone Dimartino, University of Canterbury, Christchurch, NEW ZEALAND 11:50 AM L-211 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 L-212 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 Workshop sponsored by AkzoNobel "Advances in the Development of Stationary Phases for Preparative Chromatography" Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of AkzoNobel by Monday @ 5:00 PM

12:45-2:00 PM Free Vendor Workshop sponsored by LEWA-Nikkiso America "New LPLC Pilot and Production Platform with Buffer In Line Capability" Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of LEWA-Nikkiso America by Monday @ 5:00 PM

POSTER SESSION II - sponsored by Bristol-Myers Squibb Poster Session Chairs: Arvind Rajendran, University of Alberta, CANADA, and Owen Thomas, University of Birmingham, UK

2:00-3:20 PM POSTER SESSION II - sponsored by Bristol-Myers Squibb Posters in the P-200 series will be presented on Tuesday in Poster Session II Location: Millennium Exhibit Hall, 2nd floor



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 Location: Commonwealth Hall B, 2nd floor

3:20 PM L-213 Process Development for Intermediates and APIs. Olivier Dapremont, AMPAC Fine

Chemicals, Rancho Cordova, CA, USA 3:40 PM L-214 SMB Chromatography with Internal Recycle to Isolate Intermediately Adsorbing

Stereoisomers from Complex Mixtures. Dawid Kiwala1, Dorota Antos

2, Andreas Seidel-

Morgenstern1,

1Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg,

GERMANY; 2Rzeszow University of Technology, Rzeszow, POLAND

4:00 PM L-215 Model-based Deterministic Approach for Optimizing Design and Operation of

Simulated Moving Bed Reactor. Shan Tie1, Balamurali Sreedhar

2, Gaurav Agrawal

1, Jungmin

Oh2, Megan Donaldson

2, Alfred Schultz

2, Timothy Frank

2, Andreas Bommarius

1, Yoshiaki

Kawajiri1,

1Georgia Institute of Technology, Atlanta, GA, USA;

2The Dow Chemical Company,

Midland, MI, USA 4:20 PM L-216 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

8B. Tuesday Parallel Session: Bioprocess Chromatography Session Chair: Andre Dumetz, GlaxoSmithKline, King of Prussia, PA, USA Location: Commonwealth Hall C, 2nd floor

3:20 PM L-217 Column Simulation Approach to Understanding High Throughput Miniature

Chromatography Column System Differences and Their Effects on Process Performance. William R. Keller

1, Steven T. Evans

2, Gisela Ferreira

2, David Robbins

2, Steven M. Cramer

1,

1Rensselaer Polytechnic Institute, Troy, NY, USA;

2MedImmune, Gaithersburg, MD, USA

3:40 PM L-218 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 L-219 Preparative Separation and Characterization of Immunoglobulin G Charge

Variants. Beate Hintersteiner1, Nico Lingg

1, Zhang Peiqing

2, Manfred Schuster

3, Alois

Jungbauer1,

1University of Natural Resources and Life Sciences Vienna, Vienna, AUSTRIA;

2Bioprocessing Technology Institute, Singapore, SINGAPORE;

3Apeiron Biologics, Vienna,

AUSTRIA 4:20 PM L-220 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 Location: Commonwealth Hall C, 2nd floor

4:50 PM L-221 Continuous Chromatography in Industrial Biotechnologies. Eric Valery, Benjamin

Boissier, NovaSep, Lyon, FRANCE 5:10 PM L-222 Removal of Aggregates from Protein A Purified Monoclonal Antibody by Multi-

column Continuous Hydroxyapatite Chromatography. Anthony Grabski, Tom VanOosbree, Beth Hammer, Alla Zilberman, Robert Mierendorf, Semba Biosciences Inc., Madison, WI, USA

5:30 PM L-223 Robust Design of Adenovirus Purification by Two-column, Simulated Moving-bed,

Size-exclusion Chromatography. Piergiuseppe Nestola1, Ricardo Silva

1, Cristina Peixoto

1,

Manuel Carrondo1, Jose Mota

2,

1IBET, Oeiras, PORTUGAL;

2FCT/UNL & IBET, Caparica,

PORTUGAL 5:50 PM L-224 Countercurrent Tangential Chromatography for Continuous Monoclonal Antibody

Purification. Andrew Zydney1, Oleg Shinkazh

2, Amit Dutta

2, Boris Napadensky

2, Travis Tran

2,

Achyuta Teella2,

1Penn State, University Park, PA, USA;

2Chromatan, State College, PA, USA

6:10 PM Pause

9B. Tuesday Parallel Session: Chromatographic Theory Session Chair: Attila Felinger, University of Pecs, Pecs, HUNGARY Location: Commonwealth Hall B, 2nd floor

4:50 PM L-225 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

5:10 PM L-226 The Curious Case of the Delta Shock. Simon Jermann

1, Franziska Ortner

1, Marco

Mazzotti1, Arvind Rajendran

2,

1ETH Zurich, Zurich, SWITZERLAND;

2University of Alberta,

Edmonton, CANADA 5:30 PM L-227 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 L-228 Getting More from Your Chromatograms. David Pfister, Massimo Morbidelli, ETH

Zurich, Zurich, SWITZERLAND 6:10 PM Pause


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 Location: Commonwealth Hall D, 2nd floor

8:00 AM L-301 Complex Peptide Pharmaceuticals: Purification and Chromatography Strategies.

Gary Erickson, CBL Biopharma LLC, Boulder, CO, USA 8:20 AM L-302 Peptide Purification: One Size Does Not Fit All. Steven McIntyre, Alastair Hay, Almac

Group Ltd., Craigavon, UK 8:40 AM L-303 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 L-304 Peptide Purification: A Bridging the Gap Between Discovery and Development.

Regina Black, Shawn Brueggemeier, Bristol-Myers Squibb, New Brunswick, NJ, USA 9:20-9:50 AM Break

Location: Commonwealth Hall D Foyer, 2nd floor

11. Wednesday Session: Chromatography for Large Biomolecule Purification Session Chair: David Roush, Merck & Co., Inc., Kenilworth, NJ, USA Location: Commonwealth Hall D, 2nd floor

9:50 AM L-305 Preparative High Resolution Separation of VLPs Variants. Petra Steppert, Daniel

Burgstaller, Alois Jungbauer, BOKU, Vienna, AUSTRIA 10:10 AM L-306 Purification of Virus-like Particles: Downstream Process Development for a

Candidate Hepatitis C Vaccine. Ricardo Silva1, Alex Xenopoulos

2, Andreas Stein

3, Ana

Coroadinha4, Cristina Peixoto

4, Paula Alves

4, Manuel Carrondo

5,

1iBET, Oeiras, PORTUGAL;

2EMD Millipore, Bedford, MA, USA;

3Merck KGaA, Darmstadt, GERMANY;

4iBET | ITQB-UNL,

Oeiras, PORTUGAL; 5iBET | ITQB-UNL | FCT-UNL, Oeiras, PORTUGAL

10:30 AM L-307 Establishment of a High-throughput Platform for the Production of Virus-like

Particles in E. coli. Pascal Baumann1, Christopher Ladd Effio

1, Claudia Weigel

1, Philipp

Vormittag1, Anton Middelberg

2, Stefan Oelmeier

1, Juergen Hubbuch

1,

1Karlsruhe Institute of

Technology (KIT), Karlsruhe, GERMANY; 2University of Queensland, Brisbane, AUSTRALIA

10:50 AM L-308 Purification of Plasmid DNA using Methacrylate Monolith Bearing Combination of

Ion-exchange and Hydrophobic Groups. Ales Podgornik1, Vida Smrekar

2,

1FKKT, Ljubljana,

SLOVENIA; 2Ampliphi d.o.o., Ljubljana, SLOVENIA



12. Wednesday Session: Monoliths and Membrane Chromatography Session Chair: Abraham Lenhoff, University of Delaware, Newark, DE, USA Location: Commonwealth Hall D, 2nd floor

11:10 AM L-309 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 L-310 Membrane Filtration Can Substitute Chromatographic Purification Steps for Plant-

derived and ELP-tagged Biopharmaceutical Proteins. Johannes Buyel1, Patrick

Opdensteinen2, Hannah Gruchow

2, Rainer Fischer

2,

1RWTH Aachen University, Aachen,

GERMANY; 2Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Aachen,

GERMANY 11:50 AM L-311 Novel Perfusion Media of Pulverized Monolithic Silica Enabling High Performance

with Low Pressure in Peptide and Protein Separation. Hongzhi Bai1, Mika Watanabe

2,

Teruhiko Kanno2, Takeshi Ohtani

2, Riichi Miyamoto

1, Kazuki Nakanishi

3,

1SnG Inc., Kyoto,

JAPAN; 2Hamari Chemicals Ltd., Osaka, JAPAN;

3Kyoto University, Kyoto, JAPAN

12:10 PM L-312 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

12:30-12:40 PM Presentation of Awards to Winners of the Best Poster Competition 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 Location: Commonwealth Hall D, 2nd floor

2:00 PM L-313 Analytical and Preparative SFC Can be Used as Powerful Tools in the Trace

Impurity Separation, Measurement, Isolation, and Structural Assignment Workflow. John McCauley

1, Marian Twohig

2,

1Waters SFC, New Castle, DE, USA;

2Waters, Milford, MA, USA

2:20 PM L-314 Using SFC and Polysaccharide Stationary Phases for Fast and Effective Chiral

Separation Screening with Conversion to Liquid Chromatography for Larger Scale Separations. J. Preston

1, Julissa Fernandez

1, Michael McCoy

1, William Farrell

2,

1Phenomenex,

Torrance, CA, USA; 2Pfizer Global R&D, La Jolla, CA, USA

2:40 PM L-315 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 L-316 Guidelines for Reliable Scale-up Scale Up in Preparative Supercritical Fluid

Chromatography. Torgny Fornstedt1, Martin Enmark

1, Dennis Asberg

1, Joergen Samuelsson

1,

Andrew Shalliker2,

1Department of Engineering and Chemical Sciences Karlstad University,

Karlstad, SWEDEN; 2Australian Centre for Research on Separation Science School of Science

and Health University of Western Sydney, Penrith, AUSTRALIA 3:20-3:40 Pause



14. Wednesday Session: Centrifugal Partition Chromatography / Counter Current Chromatography (CPC / CCC) Session Chair: Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA Location: Commonwealth Hall D, 2nd floor

3:40 PM L-317 Scale-up Rules in Centrifugal Partition Chromatography: Towards Industrial

Solutions. Luc Marchal1, Alexis Kotland

1, Sebastien Chollet

2, Jean-Hugues Renault

2,

1Nantes

University, Saint Nazaire, FRANCE; 2Reims University, Reims, FRANCE

4:00 PM L-318 Process Intensification and Scale Up in pH-zone Refining Centrifugal Partition

Chromatography: Case of the Purification of Key Materials in the Semi-synthesis of Anti-Cancer Drugs. Sebastien Chollet

1, Claire Mairot

2, Loic Brabant

3, Alexis Kotland

2, Jean-Marie

Autret3, Gilles Calmels

3, Catherine Diard

3, Jane Hubert

1, Luc Marchal

2, Jean-Hugues Renault

1,

1URCA, Reims, FRANCE;

2University of Nantes, Saint-Nazaire, FRANCE;

3Pierre Fabre,

Gaillac, FRANCE 4:20 PM L-319 Advances in the Automation of Method Development and Prep Purification in

Counter Current Chromatography (CCC). Gary Yanik1, Leo Hsu

2, Xiqin Yang

2, Dave

Thornton2,

1PDR-Separations.com, Palm Beach Gardens, FL, USA;

2GSK, King of Prussia, PA,

USA 4:40 PM L-320 Automated Method Development and Scale-up of Countercurrent

Chromatography at GSK. David Thornton1, Xiqin Yang

1, Gary Yanik

2, Leo Hsu

1,

1GlaxoSmithKline, King of Prussia, PA, USA;

2PDR 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 Location: Commonwealth Hall D, 2nd floor

5:10 PM L-321 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 L-322 High-throughput Process Development for the Masses: Expanding the Usability

of Mini-column Liquid Handler Systems through Improved User Interface and Enhanced System Capabilities. Sethu Siva

1, Daniel Leach

2,

1Biogen Idec, Research Triangle Park, NC,

USA; 2Tecan US, Morrisville, NC, USA

5:50 PM L-323 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 Location: Commonwealth Hall B/C, 2nd floor


Monday Poster Session I Presentations Posters in the P-100 series will be presented on Monday in Poster Session I @ 2:00 - 3:20 PM

Board size 42 inches high by 42 inches wide (107cm x 107cm) See PREPsymposium.org for details regarding poster guidelines

P-M-101 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

P-M-102 Novel Purification Application of Capto(TM)Core700 Chromatography Media.

Sheng-Ching Wang1, Anders Ljunglof

2, Misha Varma

1, Marc Wenger

1, John Daicic

2, Michael A.

Winters1,

1Vaccine BioProcess Research and Development Merck & Co., West Point, PA, USA;

2GE Healthcare Bio-Sciences AB, Uppsala, SWEDEN

P-M-103 Integrated Process for High Yield and High Conversion Protein PEGylation.

David Pfister, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND P-M-104 Combined Approach for Quick and Easy Design of a Chromatographic Polishing Step.

Rushd Khalaf1, Julia Heymann

2, Matteo Costioli

2, Florence Monard

2, Massimo Morbidelli

3,

1Institute for Chemical and Bioengineering Department of Chemistry and Applied Biosciences

ETH Zurich, Zurich, SWITZERLAND; 2Merck Serono S.A., Zurich, SWITZERLAND;

3ETH

Zurich, Zurich, SWITZERLAND P-M-105 Evaluating Optima for Pseudo-ternary Separations in Simulated Moving Bed

Chromatography. Francisco Vitor Santos Da Silva1, Bettina Kattein

2, Andreas Seidel-

Morgenstern3,

1Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg,

GERMANY; 2Technical University Braunschweig, Braunschweig, GERMANY;

3Otto von

Guericke University Magdeburg, Magdeburg, GERMANY P-M-106 High Performance Size Exclusion Chromatography of Virus-like Particles. Petra Steppert,

Daniel Burgstaller, Alois Jungbauer, BOKU, Vienna, AUSTRIA P-M-107 Comparison of Multi-column Continuous Protein A Capture Processes by Simulation and

Optimization. Daniel Baur1, Monica Angarita

1, Thomas Mueller-Spaeth

2, Fabian Steinebach

1,

Massimo Morbidelli1,


2ChromaCon AG, Zurich,

SWITZERLAND P-M-108 Parameter-free Mechanistic Prediction of Saturation Capacity in Ion Exchange

Chromatography. Fabian Steinebach, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND

P-M-109 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

P-M-110 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

P-M-111 A Comparison of Multimodal Chromatographic Resins: Protein Binding and Selectivity.

Leslie Wolfe, Eric Suda, Carnley Norman, Abhinav Shukla, KBI Biopharma, Durham, NC, USA P-M-112 Affinity Capture of F(ab)2 Fragments by Twin-column Counter-current Chromatography.

Nicole Ulmer1, Thomas Mueller-Spaeth

2, Lars Aumann

2, Benjamin Neunstoecklin

3, Michael

Bavand2, Massimo Morbidelli

1,


2ChromaCon AG, Zurich,

SWITZERLAND; 3Novartis Pharma AG, Basel, SWITZERLAND




P-M-113 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

P-M-114 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

P-M-115 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

P-M-116 Effects of Line Defects in Porous Media Studied through 3D Printing. Conan Fee,

Suhas Nawada, Simone Dimartino, University of Canterbury, Christchurch, NEW ZEALAND P-M-117 Application of High Throughput Resin Tips for Chromatography Development.

Michael Rauscher, John Welsh, Jennifer Pollard, Merck & Co. Inc., Kenilworth, NJ, USA P-M-118 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

P-M-119 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

P-M-120 Extending the Potential of Moment Analysis in Chromatography. Shamsul Qamar,

Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

P-M-121 Establishment of a High-throughput Platform for the Production of Virus-like Particles in

E. coli. Pascal Baumann1, Christopher Ladd Effio

1, Claudia Weigel

1, Philipp Vormittag

1, Anton

Middelberg2, Stefan Oelmeier

1, Juergen Hubbuch,

1Karlsruhe Institute of Technology (KIT),

Karlsruhe, GERMANY; 2University of Queensland, Brisbane, AUSTRALIA

P-M-122 Evaluating Integrity Breach of Preparative Columns (A Study on Q Sepharose Resin).

Shaun Grier, Saani Yakubu, Shire, Lexington, MA, USA P-M-123 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

P-M-124 Enhancing Hydrolytic Stability of Bonded Phases: Pendant Dipodal Silanes.

Barry Arkles, Alison Sikorsky, Craig Smith, Gelest Inc., Morrisville, PA, USA P-M-125 Adsorption Equilibrium and Kinetics of Monomer-Dimer Monoclonal Antibody Mixtures

on a Cation Exchange Resin. Jason Reck1, Timothy Pabst

2, Alan Hunter

2, Xiangyang Wang

2,

Giorgio Carta1,

1University of Virginia, Charlottesville, VA, USA;

2MedImmune, Gaithersburg,

MD, USA




P-M-126 Optimization of Dispersive Liquid–Liquid Microextraction Coupled with Gas

Chromatography-Negative 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

P-M-127 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

P-M-128 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

P-M-129 Systematic Interpolation Method to Predict Protein Elution based on HTS Isotherm Data.

Arch Creasy1, Gregory Barker

2, Yan Yao

2, Giorgio Carta

1,

1University of Virginia, Charlottesville,

VA, USA; 2Bristol-Myers Squibb, Hopewell, NJ, USA

P-M-130 Avoiding a Lifetime of Problems: Overcoming Fouling and Bed Integrity Issues During

Small-Scale Chromatography Cycling Studies. Andrew Pike1, Phillip Smith

2, Bruno

Marques2, Kent Göklen

2,

1Biopharm CMC, Philadelphia, PA, USA;

2GlaxoSmithKline, King of

Prussia, PA, USA P-M-131 Accelerating Drug Development; Introducing Target Specific Affinity Tools for

Characterization, Purification and Manufacturing of Biotherapeutics. Bruce Dawson1,

Gerwin Grit2, Frank Detmers

2, Kwasi Antwi

2,

1Thermo Fisher Scientific, Carlsbad, CA, USA;

2Thermo Fisher Scientific, Leiden, THE NETHERLANDS

P-M-132 Merged Organic/Inorganic Silica Material for Purifications in Reversed Phase Preparative

Chromatography at Elevated pH. Fredrik Lime, Robert Fredriksson, Per Jageland, Joakim Hogblom, AkzoNobel/Kromasil, Bohus, SWEDEN

P-M-133 Isolation of Vanillin from Vanilla Extract by a Combination of Flash and Prep HPLC.

Laine Stewart, Phil Shymanski, Karen Kleman, Gilson, Inc., Middleton, WI, USA P-M-134 A Detailed Mechanistic Model for Predicting Protein A Chromatography Column

Performance. Justin Weinberg, Todd Przybycien, Carnegie Mellon University, Pittsburgh, PA, USA

P-M-135 Developing a Predictive Model of Column Back Pressure at Manufacturing Scale.

Lee Bink, GlaxoSmithKline, King of Prussia, PA, USA P-M-136 Core-Shell Media, Fully Porous Media and pH as Tools for Preparative HPLC. Marc Jacob,

J. Preston, Phenomenex, Torrance, CA, USA P-M-137 Concentration, Isolation and Removal of Sample Impurities using Extraction-Injection in

Preparative Supercritical Fluid Chromatography. Geoffrey Cox, PIC Solution Inc., Media, PA, USA

P-M-138 Determinants of Protein Elution Rates from Preparative Ion-exchange Adsorbents.

James Angelo, Abraham Lenhoff, University of Delaware, Newark, DE, USA




P-M-139 Benefits of High Resolution AEX Polishing in a Monoclonal Antibody 2-Step Process.

Malcolm Pluskal, Manav Mehta, Shelly Parra, Andy Tomlinson, Thermo Fisher Scientific, Bedford, MA, USA

P-M-140 Influence of Extra-Column Peak Broadening on the Performance of Small Pre-Packed

Chromatography Columns. Susanne Schweiger1, Christian Jungreuthmayer

1, Rupert

Tscheließnig1, Nathalie Wehrwein

2, Jasmin Haas

2, Tim Schroder

2, Astrid Durauer

3, Alois

Jungbauer3,

1acib GmbH, Vienna, AUSTRIA;

2Atoll GmbH, Weingarten, GERMANY;

3University

of Natural Resources and Life Sciences, Vienna, AUSTRIA P-M-141 Fast Centrifugal Partitioning Chromatography. Robert Driscoll, Robatel, Inc., Pittsfield, MA,

USA; Jeremy Meucci, Rousselet-Robatel Kromaton, Annonay, FRANCE (presented by Greg Cybulski, Robatel, Inc.)

P-M-142 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

P-M-143 Understanding and Enhancing Selectivity in Multimodal Chromatography through Ligand

Design and Biophysics. Steven Cramer, Rensselaer Polytechnic Institute, Troy, NY, USA P-M-144 Chiral Chemistry and Supercritical Fluid Chromatography (SFC) on a Chiral Stationary

Phase (CSP) of Flavors and Fragrance. Ted Szczerba, Jelena Kocergin, Jennifer Favaro, Regis Technologies, Inc., Morton Grove, IL, USA

P-M-145 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

P-M-146 High Throughput Methodology for Resin Characterization and Chromatographic Step

Development of Biopharmaceuticals in Downstream Process Development. Grace Ma, Andre Dumetz, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-M-147 Predictive QSAR Models of in silico Designed Fab Fragment Variant Libraries.

Julie Robinson1, Hanne Sophie Karkov

1, James Woo

1, Siddharth Parimal

1, Berit Olsen Krogh

2,

Haleh Ahmadian2, Steven M. Cramer

1,

1Rensselaer Polytechnic Institute, Troy, NY, USA;

2Novo

Nordisk, Malov, DENMARK P-M-148 Development of a Mixed-acid Elution Strategy for Protein A Chromatography to Reduce

the Risk of mAb Aggregation during Low pH Viral Inactivation. Brian Bowes, Michael Beck, Eli Lilly and Company, Indianapolis, IN, USA


Tuesday Poster Session II Presentations Posters in the P-200 series will be presented on Tuesday in Poster Session II @ 2:00 - 3:20 PM


P-T-201 Minor Whey Proteins Separation using Cation Exchange Chromatography.

Naeimeh Faraji, Ajay K. Ray, Western University, London, CANADA P-T-202 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

P-T-203 Comparing Definitive Screening Design to Traditional Experimental Designs for

Hydrophobic Interaction Chromatography Optimization. Lily Tsang1, Kedar Dave

2, Joseph

Calzada3, Gregory Barker

3, Michael Borys

4, Zhengjian Li

4, Yi Li

4,

1Bristol-Myers and Squibb,

Seattle, WA, USA; 2Bristol-Myers and Squibb, East Syracuse, NY, USA;

3Bristol-Myers and

Squibb, Bloomsbury, NJ, USA; 4Bristol-Myers and Squibb, Hopkinton, MA, USA

P-T-204 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. Schadock-Hewitt, Clemson University, Clemson, SC, USA

ay Poster P-T-205 Adsorption Model for Charge Isoforms of Monoclonal Antibodies. Fabian Steinebach,

David Pfister, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND

P-T-206 Fundamental Studies of Liquid Chromatography under Cryogenic Conditions. Gorgi Pavlov, James T. Hsu, Lehigh University, Bethlehem, PA, USA

P-T-207 Design and Optimization of an Integrated SMB-crystallization Process using a Binary

Solvent. Balamurali Sreedhar1, Huayu Li

1, Baochun Shen

2, Ronald Rousseau

1, Yoshiaki

Kawajiri1,

1Georgia Institute of Technology, Atlanta, GA, USA;

2Kunming Medical University,

Kunming, CHINA P-T-208 Automated Chiral Method Development and Semi Prep Scale Up on a Single HPLC

Instrument. Todd Anderson, Shimadzu Scientific, Columbia, MD, USA P-T-209 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

P-T-210 SMB Online Detection with Spectral Deconvolution for Achiral Separations. Xiqin Yang

1,

Gary Yanik2, Necmi Bugdayci

2, Soydan Kavraali

2, Leo Hsu

1,

1GlaxoSmithKline, King of Prussia,

PA, USA; 2PDR-Separations, Palm Beach Gardens, FL, USA

P-T-211 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

P-T-212 Monolithic Monoliths - Overcoming the Limitations of Large Scale Polymerization.

Lev Matoh, Viktor Zalokar, Urh Cernigoj, Dusan Jakopin, Mario Simic, Bostjan Kosir, Jana Vidic, Nika Lendero Krajnc, Ales Strancar, BIA Separations, Ajdovscina, SLOVENIA

P-T-213 Using a Single Purification Process for Multiple Hepatitis B Core Antigen Chimeric

Proteins in the Development of Vaccines. Frank Gillam, Mike Zhang, Virginia Tech, Blacksburg, VA, USA




P-T-214 Analytical and Preparative SFC Can be Used as Powerful Tools in the Trace Impurity

Separation, Measurement, Isolation, and Structural Assignment Workflow. John McCauley

1, Marian Twohig

2,

1Waters SFC, New Castle, DE, USA;

2Waters, Milford, MA, USA

P-T-215 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

P-T-216 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

P-T-217 Molecular Dynamics as a Stepping Stone for Advanced Chromatography Modeling.

Anna Osberghaus, Katharina Lang, Florian Pilgram, Juergen Hubbuch, Karlsruhe Institute of Technology, Karlsruhe, GERMANY

P-T-218 Development of a cGMP-like Purification Process for Adenovirus Purification.

Mark Snyder, Randy Jacinto, Bio-Rad Laboratories, Hercules, CA, USA (presented by Kim Brisback, Bio-Rad Laboratories)

P-T-219 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

P-T-220 Capture of Biomolecules: Is Affinity Chromatography Always Best? Mark Lankford,

Liese Beenken-Rothkopf, Yaling Wu, Bruno Marques, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-T-221 Characterization of Column Performance in Downstream Protein Purification:

Comparison of Different Experimental Techniques. Christopher Gerberich, Andre Dumetz, Gerald Terfloth, GlaxoSmithKline, King of Prussia, PA, USA

P-T-222 Advanced Analytical Technologies in BioProcess Development: Applications of Online

UPLC, Two-Dimensional 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

P-T-223 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

P-T-224 Purification of Conjugated Glucose-Responsive Insulin with a Single Chromatographic

Process. Haiying Bao1, Kevin Maloney

2, Nihal Tugcu

1, Sunitha Kandula

1,

1Merck, Kenilworth,

NJ, USA; 2Merck, Rahway, NJ, USA (presented by Lauren Rockville, Merck)

P-T-225 Process Design Method for Capture Chromatography based on a Simplified Mechanistic

Model. Noriko Yoshimoto1, Yu Isakari

1, Shuichi Yamamoto

1, Ales Podgornik

2,

1Yamaguchi

University, Ube, JAPAN; 2University of Ljubljana and COBIK, Ljubljana, SLOVENIA

P-T-226 Development of an Integrated Continuous Biomanufacturing Process for the Production

of mAbs. Fabian Steinebach, Daniel Karst, Miroslav Soos, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND




P-T-227 Monolithic Silica HPLC Columns for Fast Analysis of Drugs and Biomolecules.

Karin Cabrera, Tom Kupfer, Gisela Jung, Peter Knoell, Benjamin Peters, Merck Millipore, Darmstadt, GERMANY

P-T-228 A High Throughput Approach to Hydrophobic Interaction Chromatography Step

Development for Multiple Distinct Therapeutic Biopharmaceuticals. Luke Badalaty, Grace Ma, Matt Burns, Hiren Ardeshna, Andre Dumetz, Jessica Molek, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-T-229 Describing Competitive Equilibria and Fixed-Bed Dynamics using Discrete Equilibrium

Data. Hector Octavio Rubiera Landa1, Arvind Rajendran

2, Andreas Seidel-Morgenstern

1,

1Max

Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY; 2University of Alberta, Edmonton, CANADA

P-T-230 Efficient Sanitization on Affinity Chromatography Media using Novel Sanitization Agents.

Elin Monie, Anna Gronberg, Anders Ljunglof, Magnus Wetterhall, Tomas Bjorkman, GE Healthcare, Uppsala, SWEDEN

P-T-231 Glycoform-based Separation of Antibody using Fc Receptor Immobilized Affinity Resin.

Toru Tanaka, Yoshiharu Asaoka, Natsuko Kizu, Shizuka Nishiyama, Masaru Aoki, Seigo Ooe, Yousuke Terao, Naoki Yamanaka, Teruhiko Ide, Tosoh Corporation, Ayase-shi, JAPAN

P-T-232 Selectivity of a New Type of Preparative Anion Exchange Resin for Glycosylated

Proteins. Judith Vajda1, Patrick Endres

2, Werner Conze

1, Egbert Müller

1,

1Tosoh Bioscience

GmbH, Griesheim, GERMANY; 2Karlsruher Institut fur Technik, Karlsruhe, GERMANY

P-T-233 Highly Efficient Purification of Enantiomers using Polysaccharide Type Chiral Stationary

Phases and Recycle Purification Technology. Ernest Sobkow1, Keiko Kihara

2, Hideo Gabari

2,

Takashi Sato2, Saoko Nozawa

2, Noriko Shoji

2, Noritaka Kuroda

2, Takatomo Takai

2,

1YMC

America, Inc., Allentown, PA, USA 2YMC Co., Ltd., Kyoto, JAPAN

P-T-234 Characteristics of Small Particle Polymer Media for Protein Separation in Ion Exchange

Chromatography. Shoya Yoda, Kazuhiko Tokunaga, Noriyuki Yasuda, Yoshito Fukuda, Shinya Nozaki, Shouhei Ohara, Masato Towata, Tadashi Adachi, Mitsubishi Chemical, Kitakyusyu, JAPAN

P-T-235 Adsorption Characteristics of Protein A Media MabSpeed{TM} for Affinity

Chromatography. Mayumi Kiyono-Shimobe1, Shigeharu Katsuo

2, Hideo Ikeda

2, Nozomi Itoh

2,

1Mitsubishi Chemical, Tokyo, JAPAN;

2Mitsubishi Chemical Group Science and Technology

Research Center, Inc., Yokohama, JAPAN P-T-236 Polishing of Next-generation Biomolecules by Twin-column Counter-current

Chromatography. Thomas Muller-Spath, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND

P-T-237 Novel Functional Ion Exchanger with Sulfate Group. Kosuke Araki, Koji Nakamura,

Shigeru Nakatani, Tosoh Corporation, Shunan, JAPAN P-T-238 Refolding and Direct Capture by Cation Exchange Chromatography of a Highly Disulfide-

linked Protein. Guoling Xi, Thomas Linke, Alan Hunter, Xiangyang Wang, MedImmune, Gaithersburg, MD, USA




P-T-239 Ionic Strength-Dependent Changes In Tentacular Ion Exchangers With Variable Ligand

Densities. Rahul Bhambure1, Christopher Gillespie

2, Michael Phillips

2, Heiner Graalfs

3,

Abraham Lenhoff1,

1University of Delaware, Newark, Delaware, USA;

2EMD Millipore, Bedford,

Massachusetts, USA; 3Merck Millipore, Darmstadt, GERMANY

P-T-240 Shear Stress Effects on Biologics During Ultrafiltration and Diafiltration (UF/DF).

Abhiram Arunkumar, Bristol-Myers Squibb, Hopkinton, MA, USA P-T-241 The Purification Power of New Silica-Based RP Materials. Axel Delp, Romas Skudas,

Franziska Paesler, Klaus Adrian, Matthias Joehnck, Merck KGaA, Darmstadt, GERMANY P-T-242 Sartobind® STIC for Removing Residual Contaminants at Elevated Salt Concentrations.

Hemanth Kaligotla, Gregory Krueger, Roger Alsop, Kevin Epting, Priyanka Gupta, Sartorius Stedim North America Inc., Bohemia, NY, USA

P-T-243 HMW Control in Large-Scale Manufacturing of Biologics. Nuria de Mas

1, Andrew Lee

1,

Aayush Pandey1, Sivaprakash Agastin

1, Danielle Harrison

1, Kedar Dave

2, Joseph Shiminsky

3,

Itzcoatl Pla1, Joseph Calzada

4, Gregory Barker

4, Sibylle Herzer

4, Siegfried Rieble

4,

1Bristol-

Myers Squibb, Manufacturing Sciences & Technology, Hopkinton, MA, USA; 2Bristol-Myers

Squibb, Manufacturing Sciences & Technology, East Syracuse, NY, USA; 3Bristol-Myers

Squibb, Manufacturing Technology, Devens, MA, USA; 4Bristol-Myers Squibb, Process

Development, Bloomsbury, NJ, USA

P-T-244 Novel Perfusion Media of Pulverized Monolithic Silica Enabling High Performance with Low Pressure in Peptide and Protein Separation. Hongzhi Bai

1, Mika Watanabe

2, Teruhiko

Kanno2, Takeshi Ohtani

2, Riichi Miyamoto

1, Kazuki Nakanishi

3,

1SnG Inc., Kyoto,

JAPAN; 2Hamari Chemicals, Ltd.;

3Kyoto University, Kyoto, JAPAN

P-T-245 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 P-T-246 Adsorptive Removal of Nitrate from Aqueous Phase using De-Acidite FF-IP Resin:

Determination by Ultra-performance Liquid Chromatography-mass Spectrometry. Zeid Alothman, Mu. Naushad, Moonis Khan, Mohammad Khan, King Saud University, Riyadh, KINGDOM OF SAUDI ARABIA

P-T-247 withdrawn P-T-248 Improved Protein G for the Purification of Antibody Fragments. Dai Murata, Takumi Sato,

KANEKA Corporation, Tokyo, JAPAN


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

Bio-Rad Laboratories

Biotech USA LLC

Bristol-Myers Squibb

Buchi

Chromatography Today/International LabMate

ChromWorks

DAISO Fine Chem USA

Elsevier, Journal of Chromatography A

Essential Life Solutions – emp Biotech

Genentech

Genetic Engineering News

GlaxoSmithKline

Graver Technologies

Innovations in Pharmaceutical Science

KANEKA Corporation

Knauer

Lab Bulletin

Lab Manager

Labomatic USA

LCGC

LEWA-Nikkiso America

MedImmune

Merck

Mitsubishi Chemical Corporation

NOVASEP

Pfizer

Pharmaceutical Outsourcing

Phenomenex

Purolite

Semba Biosciences

Separation Methods Technologies

Separation Science

Shire

SP Scientific-Genevac

Thermo Fisher Scientific

Tosoh Bioscience

Waters Corporation

YMC America


Leading companies at the forefront of Preparative and Process Chromatography

exhibiting state-of-the-art products, software and services ACE GLASS P.O. Box 688, Vineland, NJ 08362, USA 856-692-3333 www.aceglass.com Ace Glass Incorporated, founded 1936 in Vineland, NJ is a leader and innovator of scientific glassware, lab equipment and glass apparatus. Over our long history many thousands of scientific papers, research and discoveries have been attributed to our products. Ace Glass manufactures glass systems up to 200L in size, complete with all controls and accessory equipment. In addition to our wide-ranging product offerings, Ace Glass also fabricates custom laboratory glassware to customer necessary specifications.

AGILENT TECHNOLOGIES 2850 Centerville Road, Wilmington, DE 19808, USA 800–227–9770 www.agilent.com Agilent is committed to providing advanced laboratory solutions that help scientists solve real-world problems such as ensuring the quality of food, water, and air; managing the world’s resources and energy; and developing therapeutics and diagnostics to fight disease. AKZONOBEL/KROMASIL 281 Fields Lane, Brewster, NY 10509, USA 914-482-7798 www.kromasil.com AkzoNobel offers Kromasil®, high performance chromatographic media based on state-of-the-art spherical silica for UHPLC, HPLC and SFC analysis as well as small scale purification plus bulk material for HPLC, SFC and SMB process technology. Kromasil materials’ unique combination of pore volume and surface area, together with its very high mechanical and chemical stability is unmatched for the separation of a wide variety of substances from small molecules to peptides and proteins. Kromasil is available for an extensive range of NP, RP, SCF and chiral applications providing solutions to the pharmaceutical, natural products, food and beverage, industrial and clinical markets for over a quarter of a century. BIO-RAD LABORATORIES Life Science Group, 2000 Alfred Nobel Drive, Hercules, CA 94547, USA 800-4-BIORAD (800-424-6723) www.bio-rad.com/process Bio-Rad Laboratories is a leading provider of innovative tools to the life science and clinical diagnostics markets, where the company’s products are used for scientific discovery, drug development, and biopharmaceutical production. Bio-Rad’s Life Science Group has long served the bioprocessing industry by supplying advanced purification and process technologies. Bio-Rad provides a full line of scalable process chromatography resins to meet your purification needs with worldwide access and personalized service and support. BIOTECH USA LLC P.O. Box 18796, Minneapolis, MN 55418, USA 646-872-1539 www.biotechusa.us Biotech USA is proud to introduce the world's first in-line, membrane Degasser ready to use with aggressive media and organic solvents, while maintaining flow-rates of up to 150ml/min and above. Biotech USA supplies innovative laboratory products to instrument manufacturers, distributors and end users around the world. Our mission is to empower you to design a unique product in the field of liquid handling and fluid transfer components for analytical, biotech and life science users.



exhibiting state-of-the-art products, software and services BUCHI CORPORATION 19 Lukens Drive, New Castle, DE 19720, USA 302-652-3000 www.buchi.com For 75 years BUCHI has been known as the market leader, inventor, and innovator of lab instruments based on evaporation and vacuum technologies, and as the supplier of the Rotavapor® rotary evaporators worldwide. Product offerings: Evaporation Solutions – whether you work in R&D or QC our solutions cover a wide range of needs; and Preparative Chromatography Solutions – whatever the complexity or scale of your purification process, our systems are designed to fulfill your changing needs. CHROMWORKS 101 Middlesex Turnpike, Suite 6, Burlington, MA 01813, USA 781-879-2979 www.chromworks.com We are one of the world’s foremost providers of process simulation and model-based engineering and innovation services to chromatographic separation businesses. We provide modeling software and services to our customers on various needs in simulation, design, analysis and optimization of preparative and continuous chromatography processes, such as Biochromatography and Simulated Moving Beds. For more information, send us email at <[email protected]>. DAISO FINE CHEM USA, INC. 3858 W. Carson Street, Torrance CA 90503, USA 310-540-5312 daisogelusa.com DAISOGEL

® is manufactured in our ISO9001 certified facility and bonded in our GMP-compliant facility in

Amagasaki, Japan. DAISOGEL® is available in C18, C8, C4 and more bonded phases in wide variety up to 50

micron sized particles. DAISO Fine Chem USA, Inc. offers pre-packed columns and bulk silica up to 200kg batches for large-scale production, offering high batch-to-batch reproducibility, excellent particle size distribution, consistent selectivity and high productivity, facilitating scale up and production. ESSENTIAL LIFE SOLUTIONS – EMP BIOTECH 308 Tosca Drive, Stoughton, MA 02072, USA 781-341-7240 www.essential-life.net Essential Life Solutions (Tel 781-341-7240) and emp Biotech (Tel 732-547-7421) are proud to offer a complete package of innovative high quality HPLC/TPLC chromatography columns and matrices. Along with a wide variety of glass and acrylic columns ranging from 5 mm diameters to 2 meters from Essential Life Solutions and a variety of high quality resins from emp Biotech, packed columns are an additional option. Please stop by booth 302 to discuss your requirements. GRAVER TECHNOLOGIES 200 Lake Drive, Glasgow, DE 19702, USA 610-674-3656 www.gravertech.com Graver Technologies designs, develops, and manufactures products that facilitate and enhance separation, purification, and process filtration. Graver’s pharmaceutical division specializes in API purification, precious metal scavenging/recovery, and color removal in various process streams. The kinetic properties of our Ecosorb® line enable high throughput/low capital investment, while the E-PAK® series enables ease of use cartridge applications.



exhibiting state-of-the-art products, software and services KANEKA CORPORATION 1-12-32, Akasaka, Minato-ku, Tokyo 107-6025, JAPAN 81-3-5574-8112 www.kaneka.com KANEKA CORPORATION provides value added, innovative technical solutions to our customers operating in the Medical and Biopharmaceutical fields. KANEKA KanCapA™ is a powerful affinity capture resin designed to improve your monoclonal Antibody (mAb) purification platform. Benefits: Alkaline Stability and Long Life Time; Mild Acidic Elution Conditions for All mAbs; High Binding Capacity; High Flow Rate Operation and Easy Scale Up from Pilot to Process. KNAUER Wissenschaftliche Geräte GmbH Hegauer Weg 38, 14163 Berlin, GERMANY 49 (0)30 809727-0 www.knauer.net KNAUER manufactures UHPLC and HPLC systems for the analytical up to the preparative range of applications. The Berlin based company is a competent partner for LC purification systems using SMB and MCSGP technologies. For high resolution analysis or purification of proteins and other biomolecules KNAUER offers perfectly matched biochromatography systems, pressure stable glass columns, and separation media. LC columns, UV/VIS/NIR and RI detection systems, and chromatography software complete the choice of high quality LC products. LABOMATIC USA 19145 Parthenia Street, Suite C, Northridge, CA 91324, USA 818-341-2906 www.zinsserna.com LABOMATIC has been active in the field of liquid chromatography for more than 35 years. Years of experience and daily contact with customers are the basis of LABOMATIC's expertise, with the ultimate aim of providing a range to state-of-the-art instruments by constantly incorporating the latest developments in technology and adapting these to customer requirements. The LABOMATIC preparative HPLC product line and custom liquid handling are being offered in North America via partnership with Zinsser NA. LCGC 485F US Highway, 1 South, Iselin, NJ 08830, USA 732-596-0276 www.chromatographyonline.com For more than 32 years, LCGC has been the gold standard relied upon by chromatographers for unbiased, nuts-and-bolts technical information with a practical focus. LCGC’s columns and peer-reviewed articles continue to bring readers practical technical advice from respected experts in liquid and gas chromatography, including hyphenated techniques; capillary electrophoresis; supercritical fluid chromatography; and more.



exhibiting state-of-the-art products, software and services LEWA-NIKKISO AMERICA, INC. 132 Hopping Brook Road, Holliston, MA 01746, USA 508-429-7403 www.lewa-inc.com LEWA-Nikkiso America, Inc. (LNA) is your global supplier of chromatography and buffer in line dilution systems for biopharmaceutical and API manufacturing. Experience the fluid engineering advantage of the LEWA Intellidrive® technology, our open architecture automation software and quality control of the industry’s most vertical supply chain. Talk to us about how a single LEWA system does the range of up to 3 conventional units while providing higher accuracy. Design consultation, manufacturing, installation, followed by our service, spare parts supply, maintenance and training is our 360° commercial certainty pledge. We listen to your ideas and produce a complete customized solution to meet your requirements. MITSUBISHI CHEMICAL CORPORATION 1-1-1, Marunouchi, Chiyoda-ku, Tokyo 100-8251, JAPAN 81-80-8460-6599 http://www.diaion.com 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. NOVASEP 23 Creek Circle, Boothwyn, PA 19061, USA 610-494-0447 www.novasep.com Novasep is a leading worldwide provider of integrated manufacturing solutions for the Life Science industries. We master a unique range of chromatographic technologies (HPLC, SFC, LPLC, continuous chromatography) for the purification of both synthetic and bio-molecules. With its unique business model, Novasep provides solutions to support strategic decision to either insource or outsource the production of our customer’s target molecules. Our offering includes process development, chromatography units (columns, pumping skids), and contract manufacturing. PHENOMENEX 411 Madrid Avenue, Torrance, CA 90501, USA 310-212-0555 www.phenomenex.com Phenomenex, with over 30 years of industry experience, technical expertise and unsurpassed dedication to our customers worldwide, offers multi-kilo quantities of HPLC Bulk Media including our new Luna(3), Jupiter, Synergi, Gemini, and Lux chiral chemistries. With exacting performance from analytical to large process scale, our media are available in a wide range of particle sizes. We offer bulk chromatographic media and services that reduce operating costs, shorten development time, and ensure that you achieve maximum return on your investment.



exhibiting state-of-the-art products, software and services PUROLITE 150 Monument Road, Bala Cynwyd, PA 19004, USA 800-343-1500 (US) or 44-778-531-8440 (UK) www.purolite.com Purolite is the only company that focuses exclusively on advanced resin technology. Headquartered in Bala Cynwyd, PA, the company has more than 30 years’ experience providing resin solutions, with dedicated R&D and manufacturing facilities in USA, China, UK and Romania, and a further R&D site in Russia. Purolite Life Sciences, started in 2012, supports R&D and production-scale applications in traditional and bio-pharmaceuticals, food production, fine chemicals and other key markets. Brands for Life Sciences include Purolite APIs and blood purification polymers, Chromalite synthetic chromatography resins, Lifetech resins for enzyme immobilization, and new Praesto agarose-based media for MAbs, plasma fractionation and recombinant protein purification. SEMBA BIOSCIENCES, INC. 601 Science Drive, Suite 110, Madison, WI 53711, USA 866-634-1114 www.sembabio.com Semba Biosciences Inc. is a life science company based in Madison, Wisconsin, USA. Founded in 2005, the company pioneered the development of bench top continuous chromatography systems. We provide innovative instruments, reagents, custom columns, and methods for efficient and scalable purification of biomolecules and chemicals to the worldwide research community. Our Octave™ line of Chromatography Systems, Pumps and accessories provides a new level of reliable, precise and cost effective means of separation perfectly suited to your most challenging separation needs. Semba Biosciences is led by a team of experienced scientists and professionals with backgrounds ranging from basic medical research to industrial process development. The company enjoys a unique combination of technical expertise in protein biochemistry, molecular biology, engineering, chemistry, and simulated moving bed chromatography. The management team has over 100 years’ combined experience in creating, developing, and providing quality, innovative products and service to the worldwide research community. SEPARATION METHODS TECHNOLOGIES, INC. (SMT) 31 Blue Hen Drive, Newark, DE 19713, USA 302-368-0610 www.separationmethods.com Separation Methods Technologies, Incorporated (SMT) is a surface chemistry research and manufacturing corporation founded in 1993. SMT's goal is to provide chromatographers with outstanding specialty columns and bulk packing materials for various separation chemistries, ranging from analytical to the process scale. The primary focus for SMT is on the creation of well-organized functional molecules on substrate surfaces for various functions, including chromatographic applications and materials engineering. SP SCIENTIFIC – GENEVAC 3538 Main Street, Stone Ridge, NY 12484, USA 845-687-0071 www.spscientific.com World leaders in Centrifugal Evaporator technology, Genevac's high performance systems are designed for use in chemistry, biology and analytical science applications. Whether concentrating a few microliters or removing up to 100 litres, our patented evaporation systems remove even the most difficult solvents and mixtures without compromising sample purity or integrity. Always at the forefront of evaporation technology Genevac present their latest Series 3 HT evaporator and EXALT a revolutionary new crystallisation technique.



exhibiting state-of-the-art products, software and services THERMO FISHER SCIENTIFIC 81 Wyman Street, Waltham, MA 02451, USA 800-678-5599 www.lifetechnologies.com/POROS Thermo Fisher Scientific supplies innovative solutions for the world's pharmaceutical and biopharmaceutical industries. With applications that span the drug development process – from drug discovery through large-scale commercial production - we provide a broad range of products and services for cell culture, purification and analytics. POROS™ and CaptureSelect™ chromatography resins offer high- performance polish and unprecedented affinity chromatography solutions. TOSOH BIOSCIENCE LLC 3604 Horizon Drive, Suite 100, King of Prussia, PA 19406, USA 800-366-4875; Customer Service 866-527-3587 www.tosohbioscience.com Tosoh Bioscience LLC, a division of Tosoh Corporation, is a major supplier of chromatography products worldwide, particularly to the pharmaceutical, biotechnology, and chemical industries. Whether your needs are basic biological research, drug discovery, medicinal chemistry, agriculture, manufacturing, or other industrial applications, Tosoh Bioscience has the optimal solution. WATERS CORPORATION 34 Maple Street, Milford, MA 01757, USA 508-478-2000 www.waters.com Waters Corporation creates business advantages for laboratory-dependent organizations by delivering scientific innovation to enable customers to make significant advancements. Waters helps customers make profound discoveries, optimize laboratory operations, deliver product performance, and ensure regulatory compliance with a connected portfolio of separations and analytical science, laboratory informatics, mass spectrometry, as well as thermal analysis. YMC AMERICA, INC. 941 Marcon Blvd., Suite 201, Allentown, PA 18109 USA 610-266-8650 www.ymcamerica.com YMC America, Inc is engaged in the technical support, sales, and distribution of YMC brand products from its main offices and laboratory and Allentown, PA, USA and the newly opened preparative chromatography support and demonstration facility located in San Diego, CA, USA. YMC products include Triart hybrid, HG Series, and Chiral Art (coated and immobilized) stationary phases, BioPro CEX and SAX resins and preparative lab, pilot and production K-Prep HPLC systems and DAC columns.

http://www.ymcamerica.com/


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