PREP 2015 Preliminary Scientific Program

Transcription

—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.
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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
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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.
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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.
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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.
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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.
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Monday, July 27, 2015
7:15 AM
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
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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
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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
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
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1
1
2
Mechanistic Model. Noriko Yoshimoto , Yu Isakari , Shuichi Yamamoto , Ales Podgornik ,
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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
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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
Page 8
Tuesday, July 28, 2019
FREE VENDOR WORKSHOP
6:30-8:00 AM

"TBA" sponsored by Thermo Fisher Scientific
7:15 AM
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
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
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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
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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
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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
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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
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Size-exclusion Chromatography. Piergiuseppe Nestola , Ricardo Silva , Cristina Peixoto ,
1
2 1
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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
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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
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
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Wednesday, July 29, 2015
7:15 AM
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
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
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
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
Page 16

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
Page 17

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
Page 18

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
Page 19

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
1
1
Page 20

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
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]
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
Page 23
Page 24

PREP 2015 Preliminary Scientific Program

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