prep 2010 symposium and exhibit11:30 am high-throughput screening of cleaning-in-place protocols for...

1 | P a g e | PREPsymposium.org

PREP 2010 Symposium and Exhibit

Symposium Chairman Georges Guiochon, University of Tennessee and Oak Ridge National Laboratory

Organizing Committee Lois Ann Beaver, LAB Enterprises Giorgio Carta, University of Virginia

Olivier Dapremont, Ampac Fine Chemicals Georges Guiochon, University of Tennessee and ORNL

Christopher Welch, Merck & Co., Inc.

Scientific Advisory Committee Giorgio Carta, University of Virginia

Steven M. Cramer, Rensselaer Polytechnic Institute Attila Felinger, University of Pecs, Hungary

Georges Guiochon, University of Tennessee and ORNL Alois Jungbauer, BOKU, Vienna

Abraham M. Lenhoff, University of Delaware Marco Mazzotti, ETH Zürich

Kathleen Mihlbachler, Bristol-Myers Squibb, Co. Larry Miller, Amgen, Inc.

Massimo Morbidelli, ETH Zürich Joan Newburger, Johnson & Johnson Consumer Products Worldwide

Neville G. Pinto, University of Cincinnati David Robbins, MedImmune, Inc.

Andreas Seidel-Morgenstern, Max-Planck Institute, Magdeburg

Industrial Advisory Committee Michael Li, Asahi Kasei Bioprocess

Russell Frost, Bio-Rad Laboratories, Inc. Geoffrey B. Cox, Chiral Technologies, Inc.

Eric Valery, Novasep SAS Ian Sellick, Pall Life Sciences, Inc. Gary W. Yanik, PDR-Chiral, Inc.

Franco Spoldi, Perkin Elmer LAS, Inc. T. Nicholas Mitchell, Sohve Corporation

Sponsors

Symposium / Exhibit Manager Ms. Janet Cunningham, Barr Enterprises

www.linkedin.com/in/barrenterprises Phone 301-668-6001 • Email [email protected]

The use of cameras and cell phones are not permitted during program sessions. Cameras are permitted on the

exhibit floor; however, permission from the exhibitors involved must be obtained before photographs can be taken.

Opinions expressed by individuals presenting abstracts and workshops are not necessarily the opinions of the PREP 2010 Symposium


PREP 2010 Preliminary Scientific Program

Sunday, May 9, 2010

EDUCATIONAL TRAINING WORKSHOPS − Must pre-register in order to attend −

WORKSHOP 1 8:30 am–12:30 pm Location: Commonwealth A-1 (2nd floor) Preparative Chromatography for the Purification of Intermediates and API Lecturers: Dr. Kathleen Mihllbachler, Bristol-Meyers Squibb, and Dr. Olivier Dapremont, Ampac Fine Chemicals This workshop will focus on development of method for the preparative purification of small molecules for the pharmaceutical industry. After an introduction of the basics of liquid chromatography for small molecule, the instructors will present a practical approach to the development of preparative separation for Batch HPLC and Simulated Moving Bed through a series of examples. The attendees will learn valuable information and techniques to apply in the laboratory to increase throughput and performances. A book of the course will be provided to each attended at completion of the training. The book will contain copies of the slides as well as additional tables of data relevant to preparative chromatography. Dr. 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. Bio: Ph.D. from the University Pierre & Marie Curie in Paris; Prochrom (France), a manufacturer of chromatographic equipment; Chiral Technologies Europe (France), in charge of kilo scale separation service using SMB; and Aerojet Fine Chemicals, now AMPAC Fine Chemicals. Dr. Dapremont is co-author of a dozen publications and 5 patents related to SMB technologies. Dr. Mihlbachler has worked in the field of separation technology with an emphasis on chromatography for the last 15 years. In her current role as a Sr. Research Investigator II in PRD at BMS (New Brunswick, NJ), she develops purification/separation processes for pharmaceutical intermediates and API, in particular for chiral compounds and peptides. Dr. Mihlbachler held positions at Pharmacia/Pfizer (kg-scale chiral separation) and Eli Lilly and Company where she also evaluated multi-column continuous chromatography for bio-molecule purification. Dr. Mihlbachler received a doctoral degree in chemical engineering from the O.-v.-Guericke University Magdeburg, Germany, under the direction of Profs. Guiochon and Seidel-Morgenstern. She authored a chapter on SMB in “Advances in Large-Scale Biopharmaceutical Manufacturing and Scale-Up Production” and co-authored 11 articles. Since 2003 she has co-lectured workshops on “Adsorption Isotherms". She has also served as the 2009-2010 Vice-Chair of section Bioseparations at AIChE.


Sunday, May 9, 2010

EDUCATIONAL TRAINING WORKSHOPS

− Must pre-register in order to attend −

WORKSHOP 2 1:30–5:30 pm Location: Commonwealth A-1 (2nd floor) Bringing Biomolecules to Market (and keeping them there) Lecturers: Dr. Joan Newburger, Johnson & Johnson Consumer Products Worldwide, and Ms. Lois Ann Beaver, LAB Enterprises New drug products start with innovation. Frequently the most impactful drugs addressing critical medical needs, must overcome significant process and regulatory hurdles to gain approval and reach the patient. Everyone in the industry understands that the costs and timeframes are huge, that numerous problems can derail progress and that setbacks can affect the viability of the product or even the viability of the business itself. The outcome of a decade’s long and continuing concerted effort by members of the regulatory community and industry carried out within the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and in other venues, (ISPE, WHO, AAPS, International Society of Pharmaceutical Engineers, World Health Organization, American Association of Pharmaceutical Scientists) resulted in certain approaches derived from principles of Quality and Risk Management that encompass all aspects of bringing drugs to market, from product development to commercial production. Quality by Design, Quality Systems Management, Science-based Risk Management., Process Analytical Technology and Continuous Process Improvement are tools that can be incorporated into basic drug development processes. The potential benefits to industry are diverse and can include lower production costs, faster approvals, fewer recalls, new patents and increased regulatory flexibility. Time and dollars invested in implementation should yield measurable value. In this workshop 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 concepts and tools 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. Dr. Newburger has worked in pharmaceutical development for over 25 years at Wyeth Ayerst, Bristol-Myers Squibb and, currently, Johnson & Johnson. During the first half of her career, she led separations groups supporting medicinal, formulations and process chemists. For the past 7+ years, Dr. Newburger has led cross-functional teams, including clinical, CM&C, toxicology, regulatory and commercial members, having the responsibility of developing and implementing strategies for all Phases of prescription drug development and post-Approval support. Dr. Newburger has a Ph.D. in organic chemistry from the University of New Hampshire, where she was one of the first practitioners of "modern" preparative HPLC, using a prototype of the first commercialized preparative HPLC instrument (Waters Associates Prep 500). While at Wyeth-Ayerst, Dr. Newburger began collaborating with Professor Georges Guiochon on practical applications of non-linear chromatography. She is the principal author of 4 research publications and has presented 12 invited papers on her research and on drug development. Since 1994, Dr. Newburger has taught 18 workshops on the topics of preparative chromatography and FDA CM&C Initiatives. After a multi-decade career with the U.S. Food and Drug Administration, in 2009 Lois Ann Beaver 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. Continued on next page


Sunday, May 9, 2010

EDUCATIONAL TRAINING WORKSHOPS

− Must pre-register in order to attend −

Bringing Biomolecules to Market (and keeping them there) (continued) 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. With degrees in chemistry and mathematics, Lois joined FDA as an analytical chemist in the lab in Buffalo, NY then was invited to FDA regulatory headquarters to oversee nationwide trace analysis of chemical residues and contaminants. While at FDA, she took advanced studies in analytical chemistry and international law at Georgetown University, and numerous courses at the State Department Foreign Services Institute. During her career, she functioned as a compliance officer advising on FDA law, as a program officer developing a management information system, and as a congressional liaison officer. While working at FDA, she co-founded a successful company that produced preparative chromatographs and analytical instruments that was sold after 10 years. Lois is a member of the International Society of Pharmaceutical Engineers, the American Association of Pharmaceutical Scientists, the Regulatory Affairs Professionals Society, the Food and Drug Alumni Association, and the American Chemical Society. 6:00 – 8:00 pm SYMPOSIUM REGISTRATION & EXHIBITION OPEN

(Location: FOYER, Millennium Hall, 2nd floor) 6:00 – 8:00 pm WELCOME RECEPTION IN THE EXHIBIT HALL

(Location: Millennium Hall, 2nd floor) Reception Sponsored by Pall Life Sciences


Monday, May 10, 2010

8:15 am SYMPOSIUM REGISTRATION OPEN 9:00 am – 4:00 pm EXPOSITION (Location: Millennium Hall, 2nd floor) 8:55 am WELCOME & OPENING REMARKS

Meeting Location: Commonwealth B-C (2nd floor)

1. PURIFICATION OF MONOCLONAL ANTIBODIES Meeting Location: Commonwealth B-C (2nd floor)

9:00 am An Automated High-throughput Screening Method to Assess Monoclonal Antibody

Fit to Common Purification Process Conditions Using a Single Filter Plate. Brian D. Bowes1, Niels Richings2, Joe Naemura2, Thao Nguyen2, Ron Gillespie2, John Moscariello2, 1Department of Chemical Engineering, University of Delaware, Newark, DE 19716, USA; 2Purification Process Development, Amgen, Seattle, WA 98119, USA

9:20 am Leveraging Downstream Depth Filtration for HCP Removal in a Two-column

Purification Process of MAb. Nathan Mao, Yik Lam, Matthew Westoby, John Pieracci, Process Biochemistry, Biogen IDEC, San Diego, CA 92122, USA

9:40 am Salt Tolerant Membrane Adsorber for Robust Contaminant Removal. Nathalie

Fraud1, Rene Faber2, Yujing Yang1, Uwe Gottschalk2, 1Sartorius Stedim North America, Bohemia, NY 11716, USA; 2Sartorius Stedim Biotech GmbH, D-37079 Goettingen, GERMANY

10:00 am Rapid Method Development for MAb Purification from Challenging Feed. Kjell

Eriksson, Anders Ljunglöf and Tuomo Frigård, GE Healthcare Bio-Sciences, Björkgatan 30, SE-751 84 Uppsala, SWEDEN

10:20 am A Disposable Downstream Process for the Purification of a Monoclonal Antibody.

Emily Belcher Schirmer, Percivia, LLC, 1 Hampshire Street 5th Floor, Cambridge, MA 02149, USA

10:40 am PAUSE, EXHIBITS, POSTERS

Location: Millennium Hall, 2nd floor



2. PURIFICATION OF MONOCLONAL ANTIBODIES Meeting Location: Commonwealth B-C (2nd floor)

11:10 am Quality: Who Needs It?.Lois A. Beaver, LAB Enterprises, Chevy Chase, MD, USA 11:30 am High-throughput Screening of Cleaning-in-place Protocols for Antibody and

Antibody Fragment Purification on Affinity Chromatography Resins. Anna Grönberg, Enrique Carredano, Kjell Eriksson, Anna Mjärdestam, Susanne Nyholm Westin, Hans J. Johansson, GE Healthcare Bio-Sciences AB, Björkgatan 30, SE-751 84 Uppsala, SWEDEN

11:50 am Design and Operation of MCSGP Processes for Multiple Fraction Protein Purifications. Massimo Morbidelli, ETH Zurich, Institute for Chemical and Bioengineering, Wolfgang- Pauli-Strasse 10, 8093 Zürich, SWITZERLAND

12:30−2:00 pm PAUSE, EXHIBITS, POSTERS, VENDOR WORKSHOPS

Location of Exhibits and Posters: Millennium Hall, 2nd floor 12:45–2:00 pm Free Vendor Workshop sponsored by Pall Life Sciences

“Practical Issues for Consideration When Developing Large-Scale Chromatographic Processes for Biopharmaceuticals Manufacture. Unravelling the Mystique” Meeting Room: Commonwealth A-1 (2nd floor)

12:45–2:00 pm Free Vendor Workshop sponsored by Novasep

“Innovative Technologies for Purification of Bio Molecules” Meeting Room: Commonwealth A-2 (2nd floor)

2:00–3:25 pm POSTER SESSION I (Location: Millennium Hall, 2nd floor)

Stéphane RaoultTechnology

At Novasep, we can provide you with the best-in-class preparative HPLC systems

Preparative HPLC

Complete product range: DAC columns from 50 to 1600 mm i.d.

Pumping skid Flowrate from 10 to 10,000 L/h

Production of grams to multi-tons

www.novasep.com

Prochrom® – Hipersep®

Prochrom® Dynamic Axial Compression columns and Hipersep® HPLC pumping modules have been optimized to fulfill your increasingly stringent needs, and combine exceptional reproducibility and robustness with ease of use

Phot

o Cre

dit:

Nova

sep

• billi

otte

.fr •

7408

• 04

/201

0

Standardized line of columns and skids: Optimized value

Reduced delivery time

Easy ordering

New! 100 bar operating pressure: Maximized performance

Decreased separation time

Reduced separation costs



3. PURIFICATION OF PROTEINS Meeting Location: Commonwealth B-C (2nd floor)

3:30 pm pH Transients in Hydroxyapatite Columns - Chemistry and Dynamic Modeling.

Theresa Bankston, Laura Dattolo, Giorgio Carta, Department of Chemical Engineering, University of Virginia, Charlottesville, VA 22904-4742, USA

3:50 pm Affinity Interactions Under Chaotropic Conditions: A Kinetic and Thermodynamic

Study. Rene Ueberbacher1,2, Eva Berger2, Alois Jungbauer1,2, Rainer Hahn1,2, 1Austrian Center of Biopharmaceutical Technology, Muthgasse 18, 1190 Vienna, AUSTRIA; 2Department of Biotechnology, University of Natural Resources and Applied Life Sciences Vienna, Muthgasse 18, 1190 Vienna, AUSTRIA

4:10 pm High Performance Affinity Chromatography to Optimize Antibody Purification via Protein A Capture. Hector Osuna-Sanchez1, Candy Ng2, Eva Sorensen2, Daniel Bracewell2, Eric Valery1, 1NOVASEP Process, Boulevard de la Moselle, BP 50 - 54340 Pompey, FRANCE; 2University College London, Dept. of Biochemical Engineering, Torrington place, London WC1E 7JE, UK

4:30 pm Non-linear Isotherm with pH and Salt Dependence for Protein Adsorption in Ion-

exchange Chromatography. Bertrand Guélat1, Guido Ströhlein1,2, Thomas Müller-Späth1,2, Marco Lattuada1, Abhijit Tarafder1, Massimo Morbidelli1, 1Institute for Chemical and Bioengineering, ETH Zürich, 8093 Zürich, SWITZERLAND; 2ChromaCon AG, Technoparkstr. 1, 8005 Zürich, SWITZERLAND

4:50 pm PAUSE

4. PURIFICATION OF PEPTIDES Meeting Location: Commonwealth B-C (2nd floor)

5:10 pm Effect of Pore Shrinkage on Macromolecular Diffusion in Porous Beads. Bertrand

de Neuville, A. Tarafder, H. Thomas, M. Morbidelli, Institute for Chemical- and Bioengineering,ETH Zürich, Wolfgang-Pauli-Str. 10, CH-8093 Zürich, SWITZERLAND

5:30 pm Application of Spiral Countercurrent Chromatography to Peptides and Proteins.

Martha Knight1, Thomas M. Finn1, Adam Clayton2, John Zehmer2, 1CC Biotech LLC and 2APC Biotechnology Services, Inc., 9700 Great Seneca Highway, Rockville, MD 20850-3307, USA

5:50 pm The Benefits of Process Analytical Technology (PAT)-based Buffer Dilution in

Production Scale Bioprocesses. Michael Li1, Dagmar Meissner2, 1Asahi Kasei Bioprocess, Glenview, IL, USA; 2BioProcess Solutions, LLC, San Diego, CA, USA

6:10 pm PAUSE


Tuesday, May 11, 2010 8:30 am SYMPOSIUM REGISTRATION OPEN 9:00 am – 4:00 pm EXPOSITION (Location: Millennium Hall, 2nd floor)

5. SIMULATED MOVING BED Meeting Location: Commonwealth B-C (2nd floor)

9:00 am Comparison of Streamlined, Two-Column, Simulated Moving-Bed Processes for

Chiral Separation. Rui C. R. Rodrigues, Ricardo J. S. Silva, José P. B. Mota, Requimte/CQFB, Departamento de Química, Faculdade de Cências e Tecnologia, Universidade Nova de Lisboa, 2829-516 Caparica, PORTUGAL

9:20 am Cycle to Cycle Open Loop Control in Protein Purification Applying Continuous

Chromatography (MCSGP). Martin Krättli1, Guido Ströhlein1,2, Lars Aumann1,2, Thomas Müller-Späth1,2, Massimo Morbidelli1, 1Institute of Chemical and Bioengineering, Department of Chemistry and Applied Bioscience, ETH Zürich, CH-8093 Zürich, SWITZERLAND; 2ChromaCon AG, Technoparkstr. 1, CH-8005 Zürich, SWITZERLAND

9:40 am Separation of an Intermediate Target out of a Ternary Mixture by Continuous

Countercurrent Chromatography. Jadwiga Nowak1, Dorota Antos2, Andreas Seidel-Morgenstern1,3, 1Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY; 2Department of Chemical and Process Engineering, Rzeszów University of Technology, Rzeszów, POLAND; 3Chair of Chemical Process Engineering, Otto von Guericke University, Magdeburg, GERMANY

10:00 am Continuous Protein Purification by Simulated Moving Bed: An Open Platform for

Increased Productivity and Purity. Anthony Grabski, Robert Mierendorf, Semba Biosciences, Inc., 505 South Rosa Road, Madison, WI 53719, USA

10:20 am Does Darwin’s Theory of Evolution Apply to Chromatography? Eric Valery1, Michel

Bailly2, 1NOVASEP Process, Boulevard de la Moselle, BP 50 - 54340 Pompey, FRANCE; 2LSGC, 1 rue Grandville, 54000 Nancy, FRANCE

10:40 am PAUSE, EXHIBITS, POSTERS Location: Millennium Hall, 2nd floor


Tuesday, May 11, 2010

6. SIMULATED MOVING BED AND CHIRAL SEPARATIONS Meeting Location: Commonwealth B-C (2nd floor)

11:10 am Fast Development of a Chiral SMB Separation Under Nonlinear Chromatographic

Conditions by On-line Optimizing Control. Simon Jermann, Christian Langel, Cristian Grossmann, Marco Mazzotti, Manfred Morari, Massimo Morbidelli, ETH Zürich, Zürich, SWITZERLAND

11:30 am Purification of Pharmaceutical Intermediates on SMB with Reverse Phase Chromatography. Anil Oroskar, Abhilesh Agarwal, Asha Oroskar, Orochem Technologies, Inc., 331 Eisenhower Lane South, Lombard, IL 60148, USA

11:50 am Practical Aspects of Preparative Enantioselective Supercritical Fluid

Chromatography. Screening and Scale-up using Immobilized Polysaccharide Chiral Stationary Phases and Non-alcohol-based Modifiers. Geoffrey B. Cox, Bruce Coryell, James Lee, William Watts, Chiral Technologies, Inc., 800 N. Five Points Road, West Chester, PA 19380, USA

12:10 pm Case Study: Separation and Purification of Two Chiral Discovery Compounds using Kromasil CSPs, The Influence of Particle Size on Process Productivity in Chiral Batch Chromatography. Joakim Högblom, Sylvia Winkel Pettersson, Britt Kofoed-Hansen, Akzo Nobel, Separation Products, SE-445 80 Bohus, SWEDEN

12:30−2:00 pm PAUSE, EXHIBITS, POSTERS, VENDOR WORKSHOPS Location of Exhibits and Posters: Millennium Hall, 2nd floor

12:45–2:00 pm Free Vendor Workshop sponsored by Chiral Technologies

Meeting Room: Commonwealth A-1 (2nd floor) 12:45–2:00 pm Free Vendor Workshop sponsored by Asahi Kasei Bioprocess and KNAUER:

“Benchtop SMB and Preparative HPLC” Meeting Room: Commonwealth A-2 (2nd floor)

2:00–3:25 pm POSTER SESSION II (Location: Millennium Hall, 2nd floor)

Rapid Small-Scale Separation Services

The Fastest Way from Molecule to Market

Chiral Technologies, Inc. offers FastTrac, an expanded custom separation

service that includes rapid purification of chiral compounds in the

milligram-to-gram range. This small-scale separation service is designed

to help you accelerate pre-clinical evaluation of drug candidates.

DeDICaTeD FastTrac HPLC & SFC equIPmenT

RaPID SCReenIng

FRee-oF-CHaRge meTHoD DeveLoPmenT

HIgH enanTIomeRIC PuRITy

quICk SamPLe TuRnaRounD

For more information on our FastTrac Services, please call: 1-800-6CHIRAL ext. 268

www.chiraltech.com


Tuesday, May 11, 2010

7. SMALL SCALE SEPARATIONS Meeting Location: Commonwealth B-C (2nd floor)

3:30 pm Strategic Use of Semipreparative Supercritical Fluid Chromatography (SFC) to

Enable Pharmaceutical Lead Optimization and Early Development. Regina Black, Preparative Chemistry and Separations, Merck and Co., Rahway, NJ, USA

3:50 pm Large Scale Chiral Chromatography for the Separation of an Enantiomer to Accelerate Drug Development. Leo C. Hsu, Hyunjung Kim, Xiqin Yang, David Ross, GlaxoSmithKline, King of Prussia, PA 19406, USA

4:10 pm Preparative Liquid Chromatography for Compound Purification and Separation in Medicinal Chemistry. Ulrich Emde, Melanie Dietz, Dieter Spuck, Merck KGaA, Darmstadt; Merck Serono, MS-RTC-MLF2, Frankfurter Str. 250, D-64293 Darmstadt, GERMANY

4:30 pm Rescue Chromatography: Development of a Purification Process to Recover an

Intermediate from Mother Liquor. Andrew Hessler, Xiqin Yang, David Thornton, Leo Hsu, Chemical Development, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19406, USA

4:50 pm PAUSE

8. SMALL SCALE SEPARATIONS Meeting Location: Commonwealth B-C (2nd floor)

5:10 pm Make 'em All and Let Preparative Chromatography Sort It Out: Strategies for Highly

Productive Multikilogram HPLC Purification of a Single Compound from a Multicomponent Sample Mixture. David J. Schenk, Christopher J. Welch, Derek W. Henderson, Separation & Purification Center of Excellence, Department of Process Research, Merck & Co., Inc., Rahway, NJ 07065, USA

5:30 pm S.M.A.R.T. Software; A Solution to the Collection, Organization, and Distribution of

Data to Efficiently Manage a High-Throughput Purification and Analysis Lab. William Leister, Chris Louer, NIH Chemical Genomics Center, National Human Genome Research Institute, National Institutes of Health, 9800 Medical Center Drive, Rockville, MD 20850, USA

5:50 pm Parallel Chromatography in 96-Well Formatted MiniColumns in Multi-Step Protein Purification Process Development. Tim Schroeder, Jürgen Friedle, Atoll GmbH, Ettishofer Straße 10, D-88250 Weingarten, Germany, Irina Kostareva, Atoll-Bio USA, P.O.Box 630171, Riverdale, NY 10463, USA

6:10 pm PAUSE

Sample Prep

HPLC Columns

Instrumentation

Data Systems

Support & Training

Learn more about Varian’s solutions for purification at www.varianinc.com or email [email protected]

Gain the benefits of this single supplier solution:

• Combination of media and hardware achieves the highest yield and finest quality product.

• Robust, high performance systems for high throughput and lower purification costs.

• Expert technical services and support available, giving you the confidence of consistent high performance purification.

A global leader in preparative and process chromatographyVarian offers the most complete range of instruments, pre-packed columns and bulk media for LC purification,

from discovery to full scale manufacture. Whether you require high performance, high throughput or high yield

purification, Varian’s applications experience and expert knowledge mean you receive the optimum configuration

for your application needs.

Prep to Process LC SolutionsInstrumentation and Consumables for Purification

© 2010 Varian, Inc.

Chromatography • Spectroscopy • Mass Spectrometry • Magnetic Resonance Spectroscopy and Imaging • X-Ray Crystallography • Dissolution • Consumables • Data Systems • Vacuum


Wednesday, May 12, 2010 8:50 am PRESENTATION OF AWARDS TO WINNERS OF THE BEST POSTER COMPETITION

Meeting Location: Commonwealth B-C (2nd floor)

9. FUNDAMENTALS Meeting Location: Commonwealth B-C (2nd floor)

9:00 am A Novel Optimization Strategy for Incorporating of Additives in the Modelling

Aimed at Improved Process Optimization. Torgny Fornstedt, Lena Edström, Torgny Undin, Patrik Forssén, Department of Physical and Analytical Chemistry, Uppsala University, BMC Box 599, SE-751 24, Uppsala, SWEDEN

9:20 am Peak Parking Method for Measurement of Molecular Diffusivity in Liquid Phase

Systems. Kanji Miyabe, Graduate School of Science and Engineering for Research, University of Toyama, 3190, Gofuku, Toyama 930-8555, JAPAN

9:40 am Optimum Experimental Conditions in Preparative Chromatography. The Effect of the

Amount of Packing Material. Attila Felinger, Department of Analytical and Environmental Chemistry, University of Pecs, Pecs, Ifjusag utja 6, H-7624, HUNGARY

10:00 am Energetics of Lysozyme Adsorption onto Mesoporous Silica. Rebecca J. Desch,

Stephen W. Thiel, Neville G. Pinto, Department of Chemical and Materials Engineering, University of Cincinnati, Cincinnati, OH 45221-0012, USA

10:20 am Measurement and Analysis of Cooperative Adsorption Isotherms of Binaphthol

Enantiomers on Chiralpack AD. Ricardo J. S. Silva, Rui C. R. Rodrigues, José P. B. Mota, Requimte/CQFB, Departamento de Química, Faculdade de Cências e Tecnologia, Universidade Nova de Lisboa, 2829-516 Caparica, PORTUGAL

10:40 am PAUSE


Wednesday, May 12, 2010

10. PROCESSES Meeting Location: Commonwealth B-C (2nd floor)

11:10 am Development of a Preparative Ion Exchange Process for the Separation of

Glycosylated Whey Peptides using Membrane Adsorption Chromatography. Markus Kreuss, Elena Leeb, Ulrich Kulozik, Technische Universität München, Chair for Food Process Engineering and Dairy Technology, Weihenstephaner Berg 1, D-85354 Freising, GERMANY

11:30 am A New Multicolumn, Open-Loop Process For Ternary Separation By Solvent-

Gradient Chromatography. José P. B. Mota1, Rui C. R. Rodrigues1, Ricardo J. S. Silva1, H. Osuna-Sanchez2, E. Valéry2, 1Requimte/CQFB, Departamento de Química, Faculdade de Cências e Tecnologia, Universidade Nova de Lisboa, 2829-516 Caparica, PORTUGAL; 2NovaSep Process, Boulevard de la Moselle, BP 50 - 54340 Pompey, FRANCE

11:50 am Steady State Recycling Chromatography – Simplified Optimal Design and Options for Process Improvement. Malte Kaspereit1, Tuomo Sainio2, Achim Kienle1,3, 1Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY; 2Laboratory of Industrial Chemistry, Lappeenranta University of Technology, Lappeenranta, FINLAND; 3Otto-von-Guericke University Magdeburg, Chair for Automation/Modeling, Magdeburg, GERMANY

12:10 pm The Influence of the Memory Effect on Method Development using the

CHIRALPAK® AD®. Joel Putnam, Georges Guiochon, Department of Chemistry, University of Tennessee, Knoxville, TN 37996-1600, USA and Oak Ridge National Laboratory, Oak Ridge, TN, USA

12:30–2:00 pm PAUSE

11. NEW STATIONARY PHASES Meeting Location: Commonwealth B-C (2nd floor)

2:00 pm Comparison of Protein A Affinity Chromatography Media: An Update. Alexander

Matlschweiger1, Alois Jungbauer1, Rainer Hahn1, 1Department of Biotechnology, University of Natural Resources and Applied Life Science Vienna, Muthgasse 18, 1190 Vienna, AUSTRIA

2:20 pm Developments of Hydrophilic Polymer-based Ion Exchange Media and New

Generation Reversed Phase Packing Materials for Separation of Peptide and Protein. Ernest J. Sobkow1, Masakatsu Omote2, Takatomo Takai2, Kiyoshi Morishita2, Noriko Shoji2, Naohiro Kuriyama2, 1YMC America, Inc, Allentown, PA, USA; 2YMC Co. Ltd., Ishikawa, JAPAN

2:40 pm Salt Tolerant Adsorbents for Process Chromatography. Approaches to Improve Process Throughput and Productivity. Peter R. Levison1, Philippe Despres2, 1Pall Life Sciences, Walton Road, Portsmouth, Hampshire, PO6 1TD, UK; 2Pall France, 48 Avenue des Genottes, 95800 Cergy-Saint-Christophe, FRANCE

3:00 pm Convenient Purification of Highly Polar Compounds by New Amide-based Stationary Phases. Jerry Wang, Agela Technologies, Inc., 625 Dawson Drive, Newark, DE 19713, USA

3:20 pm ADJOURN


Monday Poster Presentations Location: Millennium Hall, 2nd floor

Session Times: 2:00 – 3:25 PM All posters will remain up for viewing all day Monday and Tuesday. All posters should be mounted onto the poster boards on Monday between 8:30 AM and 1:00 PM and not be removed until Tuesday between 3:25 PM and 5:00 PM (anything remaining after 6:00 PM on Tuesday will be discarded). See “Poster Guidelines” at www.PREPsymposium.org Thick Shear Mode Acoustic Devices to Study Biomolecular Recognition and Protein Binding. Luis F. M. Rosa, Jorge Carvalho, Rogério Rodrigues, Guilherme N. M. Ferreira, IBB-Institute for Biotechnology and Bioengineering, Centre for Molecular and Structural Biomedicine, Universidade do Algarve, Faro, PORTUGAL Methods for Improving Synthetic Peptide Isolation. Jo-Ann M. Jablonski, Thomas E. Wheat, Kenneth J. Fountain, Steven M. Collier, Waters Corporation, 34 Maple Street, Milford, MA 01757, USA Chromatographic Purification of Single-chain Fragment Variable Antibodies. Carlos Martínez Cristancho1, Andreas Seidel-Morgenstern1,2, 1Max-Planck-Institut for Dynamics of Complex Technical Systems, Magdeburg, GERMANY; 2Chair of Chemical Process Engineering, Otto-von-Guericke University, Magdeburg, GERMANY Preparative Chromatography for Purification of Immunosuppressants. Nitin S. Patil, Rakesh B. Mendhe, Rupali Desai, Harish V. Iyer, Biocon Limited, 20th KM, Hosur Road, Electronics City, Bangalore 560 100, INDIA Effect of Hydrophobicity Index and Charged State of Peptides on their Preparative Purification. Nitin S. Patil, Rakesh B. Mendhe, Shrivallabh B. Desai, Ganesh R. Iyer, T. Srinivasa, Harish V. Iyer, Biocon Limited, 20th KM, Hosur Road, Electronics City, Bangalore 560 100, INDIA A Newly Developed Hydrophilic Polymer-based Ion Exchange Chromatography Media and Purification for Immunoglobulin Y from Egg Yolk. Masakatsu Omote, Noriko Shoji, Naohiro Kuriyama, YMC Co. Ltd., Ishikawa, JAPAN Packing Materials with Advanced Technologies (High Strength, Modified Silica Gel Design) for Preparative HPLC Separation of Peptide and Protein. Masakatsu Omote, Takatomo Takai, Noriko Shoji, Naohiro Kuriyama, YMC Co. Ltd., Ishikawa, JAPAN A Quantitative Measurement of 5’-methylthioadenosine in-vitro using Liquid Chromatography–tandem Mass Spectrometry. Yibai Chen, Baiqing Tang, Warren Kruger, Anthony Yeung, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA Hemoglobinopathies Prevalence in the Universidad Santiago de Cali Afrocolombian Population. X. Gonzalez Rojas1, H. Caicedo Villegas1, A. Sanchez Mosquera1, C. Escarpetta1, C. Lasso1, J. M. Satizabal Soto1,2, Armando Lucumi-Moreno1, 1Universidad Santiago de Cali, Cali-Valle, COLOMBIA; 2Universidad Del Valle, Cali-Valle, COLOMBIA Separation and Quantitation of Anions in Different brands of Toothpaste in India by using Ion Chromatography. Shrikant R. Kulkarni, Manasi V. Ghamande, Department of Chemical Engineering, Vishwakarma Institute of Technology, Pune 411 037 (M.S.), INDIA


Monday Poster Presentations Location: Millennium Hall, 2nd floor

Session Times: 2:00 – 3:25 PM All posters will remain up for viewing all day Monday and Tuesday. All posters should be mounted onto the poster boards on Monday between 8:30 AM and 1:00 PM and not be removed until Tuesday between 3:25 PM and 5:00 PM (anything remaining after 6:00 PM on Tuesday will be discarded). See “Poster Guidelines” at www.PREPsymposium.org Evaluation of Separation Performance of Cation Exchange Media for Protein Purification and Aggregate Removal. Wei (David) Guo, B. Thiyagarajan, Nandu Deorkar, Willie Hesselink, Mallinckrodt Baker, Inc., 1904 J T Baker Way, Phillipsburg, NJ 08865, USA Alternative Chromatography Resins for the Capture of IgG. Carl Richey, April Wheeler, Kate Tavernier, Travis Holle, Rhea Smith, Process Development, Cook Pharmica LLC, IN 47403, USA Automated Parallel Chromatographic Separations in Process Development. Tim Schroeder, Jürgen Friedle, Atoll GmbH, Ettishofer Straße 10, D-88250 Weingarten, GERMANY High Capacity Cation Exchange Chromatography for Monoclonal Antibody Purification: Protein Loading and Selectivity Studies for Process Development. Jason Reck, B. Marques, C. Griffin, J. Erickson, GlaxoSmithKline, King of Prussia, PA, USA Development of New Ion Exchange Chromatography Media for Antibody Processing. Aniket Songade, James Hamzik, Yu Zhang, Jie Chen, Neil Soice, KS Cheng, Purification Product Development, BioProcess R&D, Millipore Corporation, 80 Ashby Road, Bedford, MA 01730, USA The Use of Positively Charged Adsorbers to Extend Protein A Resin Lifetime. Terri Cameron, Adam Pettler, Polly Mak, Neil Soice, Jim Neville, Ben Roman, David Peers, MSATS Recovery, Genentech, Inc., 100 New Horizons Way, Vacaville, CA 95688, USA Effect of Resin Dextran Content and Charge Density on Protein Adsorption and Transport in Dextran-modified Ion-exchange Media. Brian D. Bowes, Abraham M. Lenhoff, Department of Chemical Engineering, University of Delaware, Newark, DE, 19716 USA Multi-Component Shrinking Core Modeling of Chromatographic Breakthrough. Steven J. Traylor, Abraham M. Lenhoff, Department of Chemical Engineering, University of Delaware, Newark, DE 19716 USA Impurity Clearance using Primary Amine Membrane Adsorber. Ganesh Iyer, Maybelle Woo, Navid Khan, Jon Royce, Senthilkumar Ramaswamy, Millipore Corporation, 80 Ashby Road, Bedford, MA 01730, USA


Tuesday Poster Presentations Location: Millennium Hall, 2nd floor

Session Times: 2:00 – 3:25 PM All posters will remain up for viewing all day Monday and Tuesday. All posters should be mounted onto the poster boards on Monday between 8:30 AM and 1:00 PM and not be removed until Tuesday between 3:25 PM and 5:00 PM (anything remaining after 6:00 PM on Tuesday will be discarded). See “Poster Guidelines” at www.PREPsymposium.org Preparative Scale Fractionation of Poly(ε-caprolactone) Block Copolymers and Their Identification by Liquid Chromatography and MALDI-TOF-MS. Hasnat Ahmed, Bernd Trathnigg, C. Oliver Kappe, Robert Saf, Institute of Chemistry, Karl Franzens University Graz, Heinrichstrasse 28, A-8010 Graz, AUSTRIA Investigation of the Use of Room Temperature Ionic Liquids as Organic Mobile Phase Replacements for Reversed-phase Liquid Chromatography. Tarab Ahmada, Divya Shekara, Vijaya sree Vegesnaa, Prashanthi Kolanupakaa, Tariq Z. Ahmadb, aDepartment of Chemistry, Western Illinois University, Macomb, IL, USA; bMacomb Senior High School, Macomb, IL, USA Model for Distributed Pore Volumes. Niklas Borg, Karin Westerberg, Niklas Andersson, Bernt Nilsson, Department of Chemical Engineering, Lund University, P.O. Box 124, SE-221 00 Lund, SWEDEN Evaluation of Various Types of Stationary Phases for Peptides Separation in RP-HPLC. Akira Sugisaki1, Yuji Kirino1, Masahide Takase2, 1DAISO Fine Chem USA Inc., Santa Clara, CA 95054, USA; 2DAISO CO., LTD., Osaka, JAPAN The Development of a Highly Productive Preparative Chromatography Process for a Regioisomer Separation. Sheng Tang, Xiqin Yang, Andrew Hessler, Leo Hsu, Chemical Development, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19406, USA Easy Method Transfer Using a Universal, Sub 2μm to 10μm HPLC Media Platform. Sue Diaz, Karin Hallberg, Reno Nguyen, Scott Anderson, Laura Kaepplinger, Grace Discovery Sciences, 2051 Waukegan Road, Deerfield, IL 60015, USA Measurement of TS-131, A New Monopyridinium Oxime, by High Performance Liquid Chromatography in Rat Plasma Samples. Zeki Ilker Kunaka, Emin Ozgur Akgulb, Hakan Yarena, Tuncer Caycib, Yasemin Gulcan Kurtb, Ibrahim Aydinb, Halil Yamanb, Levent Kenara, Tuna Subasic, Erdinc Cakirb, Enis Macitd, Ayhan Sitki Demirc, Mehmet Kemal Erbilb, Jana Zdarova Karasovae, aDepartment of Medical CBRN, Gulhane Military Medical Academy, Ankara, TURKEY; bDepartment of Medical Biochemistry, Gulhane Military Medical Academy, Ankara, TURKEY; cDepartment of Chemistry, Middle East Technical University, Ankara, TURKEY; dDepartment of Analytical Toxicology, Gulhane Military Medical Academy, Ankara, TURKEY; eDepartment of Toxicology, Faculty of Military Health Sciences, Hradec Kralove, CZECH REPUBLIC Protective Effects of Antioxidants on Chronic Ethanol-induced Brain Damage. Enis Macit1, I. Tayfun Uzbay2, Z. Ilker Kunak3, 1Gulhane Military School of Medicine, Dept. of Toxicology, Ankara, TURKEY; 2Gulhane Military School of Medicine, Dept. of Pharmacology, Ankara, TURKEY; 3Gulhane Military School of Medicine, Dept. of NBC, Ankara, TURKEY


Tuesday Poster Presentations Location: Millennium Hall, 2nd floor

Session Times: 2:00 – 3:25 PM All posters will remain up for viewing all day Monday and Tuesday. All posters should be mounted onto the poster boards on Monday between 8:30 AM and 1:00 PM and not be removed until Tuesday between 3:25 PM and 5:00 PM (anything remaining after 6:00 PM on Tuesday will be discarded). See “Poster Guidelines” at www.PREPsymposium.org Effect of High pH Column Regeneration on the Separation Performances in Reversed-phase Chromatography of Peptides. David Gétaz**, Mumun Gençoglu**, Nicola Forrer*, Trevor Hopkins*, Massimo Morbidelli**, *Zeochem AG, 8707 Uetikon, SWITZERLAND; **ETH Zürich, 8093 Zürich, SWITZERLAND Preparation of Ioversol with Cheetah Flash Chromatography System and Hydrophilic Silic-bond C18 Packing Material. Wan Wang, Qunjie Wang, Agela Technologies, Inc., 625 Dawson Drive, Newark, DE 19713, USA Martin-Synge Algorithm for the Solution of Equilibrium-dispersive Model of Liquid Chromatography. Krisztian Horvath1,2, Jacob N. Fairchild1, Krzysztof Kaczmarski3, Georges Guiochon1, 1University of Tennessee, Department of Chemistry, Knoxville, TN, 37996-1600, USA; 2University of Pannonia, Department of Analytical Chemistry, P.O. Box 158, Veszprem, H-8200, HUNGARY; 3Rzeszow University of Technology, Department of Chemical and Process Engineering, 35-959 Rzeszow, POLAND Purification by LC – Flash or HPLC is There Really Difference? Linda Lloyd, S. Ball, K. Mapp, Varian, Inc., Essex Road, Church Stretton, Shropshire SY6 6AX, UK Packing and Qualification of Preparative Columns in Various Buffers: Donnan Equilibrium Effects. Kate Tavernier, April Wheeler, Travis Holle, Rhea Smith, Andy Alaska, Cook Pharmica LLC, IN 47403, USA Separation of Sesamin and Sesamolin by SMB. Ming-Tsai Liang1, Ling-Ya Wang2, Ru-Chien Liang2, Hung-En Yen3, 1Dept. of Chem. Eng., I-Shou University, Kaohsiung County, Taiwan 840; 2AsiaGiant Enginering Co. LTD. Ta-Fa Industrial Park, Kaohsiung 830, TAIWAN; 3JOJIA Bio-Tech Co., 308, Jwu-Liau Road, Ta-Hsu, Kaohsiung 840, TAIWAN Characterization of Commercial Polymeric Surfactants by Offline Two Dimensional Liquid Chromatography. Shazia Abrar (Mag), Bernd Trathnigg, Central Polymer Lab, Institute of Chemistry, Karl-Franzens University of Graz, Heinrichstraße 28, A-8010 Graz, AUSTRIA

prep 2010 symposium and exhibit11:30 am high-throughput screening of cleaning-in-place protocols for...

Documents