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Page 1: Puri˜ cation Expertise - prepsymposium.orgprepsymposium.org/documents/PREP2016FINALPROGRAMONLINE_… · irresistible pricing in advertising! Consult our Media Kit with Editorial
Page 2: Puri˜ cation Expertise - prepsymposium.orgprepsymposium.org/documents/PREP2016FINALPROGRAMONLINE_… · irresistible pricing in advertising! Consult our Media Kit with Editorial

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• Scalable purifi cation media: UHPLC – HPLC – Prep

• Silica, Polymer, and Hybrid Particle Technology Platforms

• Over 30 distinct stationary phase chemistries: for NP, RP, IEX, SEC, HILIC, Chiral

• Services available for Method Development, Purifi cation Support, Training, Validation Support

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Page 3: Puri˜ cation Expertise - prepsymposium.orgprepsymposium.org/documents/PREP2016FINALPROGRAMONLINE_… · irresistible pricing in advertising! Consult our Media Kit with Editorial

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Page 5: Puri˜ cation Expertise - prepsymposium.orgprepsymposium.org/documents/PREP2016FINALPROGRAMONLINE_… · irresistible pricing in advertising! Consult our Media Kit with Editorial

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Page 6: Puri˜ cation Expertise - prepsymposium.orgprepsymposium.org/documents/PREP2016FINALPROGRAMONLINE_… · irresistible pricing in advertising! Consult our Media Kit with Editorial

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Page 9: Puri˜ cation Expertise - prepsymposium.orgprepsymposium.org/documents/PREP2016FINALPROGRAMONLINE_… · irresistible pricing in advertising! Consult our Media Kit with Editorial

PREP 2016 Final Program Page 1

Welcome to PREP 2016 On behalf of the Organizing Committee, I welcome you again to Philadelphia and to PREP 2016, the 29th International Symposium, Exhibit & Workshops on Preparative and Process Chromatography. PREP2016 continues the tradition of driving scientific progress with an exciting technical program, providing in-depth technical education and training with an extensive workshop program, and showcasing the latest commercial technology with

vibrant exhibit. The Scientific Program includes 73 oral presentations and 72 posters addressing the most recent developments in preparative chromatography from the gram scale to the multiple ton scale for both small molecules and biomolecules. The oral program includes: keynote sessions on Industrial Protein Chromatography (1), Continuous Chromatography (2), Preparative chromatography in Drug Discovery, Development, and Manufacture (5), Preparative Supercritical Fluid Chromatography (10), and Preparative Purification of Peptides (11); plenary sessions on Understanding and Modeling Biomolecules Chromatography (6), Innovative Materials and Processes for Biochromatography (7), Chromatography for Virus Particles (12), Chromatography Fundamentals (13), and Advances in CPC, CCC, and Chiral Separations (14); and parallel sessions on Strategies and Processes for Biomolecule Purification, (3A), Monoliths and Membrane Chromatography (4A), Stationary Phases (3B and 4B) , New Developments in Affinity Chromatography (8A), New Developments and Applications of Continuous Chromatography (8B), and Column Characterization (9A), and Advances in Chromatographic Modalities for Bioprocess Applications (9B). Posters will be on display over a two-day period allowing you to interact extensively with the presenters. The restructured Training Workshop Program led by a team of internationally renowned experts includes Sunday Workshops on (1) Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Processes, (2) Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC, and (3) Regulatory Fundamentals, QbD, and Design of Experiments for Biopharmaceuticals. In addition, there will be a totally new and exciting Monday Morning Tutorial on “Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography”. The Vendor Exhibit includes 23 booths through which you can become familiar with the latest commercial advances in preparative and process chromatography. Seven Vendor Workshops sponsored by AkzoNobel/Kromasil, Bio-Rad Laboratories, DAISO Fine Chem USA, GE Healthcare, Itochu Chemicals America/Mitsubishi Chemical, Purolite Life Sciences, and Thermo Fisher Scientific will complement the exhibit with more extensive information. These workshops are free and include breakfast or lunch, but you must register in advance by visiting the vendor booth. We invite to take advantage of all of these unique training and educational opportunities and to interact with vendors and providers of chromatography media, equipment, processes, and services. I wish to thank the many people who have helped make PREP 2016 possible, most continuing after many years of service but also many new people who have joined the PREP community. Firstly, I want to thank the members of the Scientific Advisory Committee and of the Industrial Advisory Committee for their help in planning and promoting the Symposium and reviewing the abstracts. Secondly, on behalf of all the participants, I want to thank our industrial sponsors, who have provided very generous financial support, the vendors, who have contributed to the exhibit and workshops, and all of the people who have submitted so many excellent abstracts. Thirdly, I want to thank our Symposium and Exhibit Manager, Ms. Janet Cunningham of Barr Enterprises, and her staff as well as several student aides who have volunteered to ensure a smooth running of the symposium. Finally, I want to thank you for attending PREP 2016. As we begin PREP 2016, we are already thinking about future PREP Symposia. The Organizers would absolutely welcome your comments and suggestions. While you attend PREP 2016, please take note and then let us know of what you see that could be improved, what new topics could be brought to the meeting, and what new formats might provide more effective exchanges of scientific ideas and awareness of new technologies. Your feedback and ideas would be highly appreciated. In the meanwhile, I very much hope you will enjoy this meeting and that the talks, posters, exhibits, training and vendor workshops, discussions, and networking opportunities will help you solve today’s separation problems and better prepare you for the future of preparative chromatography. Giorgio Carta, University of Virginia PREP 2016 Chair

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PREP 2016 Final Program Page 2

PREP 2016 FINAL PROGRAM

PREP 2016 Chair

Giorgio Carta, University of Virginia

Organizing Committee

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

Igor Quinones-Garcia, Shire Qi (Tony) Yan, Pfizer

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

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

Industrial Advisory Committee

Jonathan Edelman, Washington Chromatography Discussion Group Marc Jacob, Phenomenex Mayumi Kiyono-Shimobe, Mitsubishi Chemical Corporation Jiali Liao, Bio-Rad Laboratories

Ceclia Mazza, AkzoNobel/Kromasil Kathleen Mihlbachler, LEWA Process Technologies Ernie Sobkow, YMC America Eric Valery, Novasep Alla Zilberman, Semba Biosciences

Poster Session Chair

Dorota Antos, Rzeszow University of Technology, Poland

Symposium / Exhibit Manager

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

[email protected] PREPsymposium.org

Use of still or video cameras and cell phones is prohibited during the oral program; and prohibited in the poster and exhibition areas without the express consent of the presenter or exhibitor. Opinions expressed by presenters, instructors and exhibitors are not necessarily the opinions of the PREP 2016 Symposium.

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PREP 2016 Final Program Page 3

Table of Contents

Page

Welcome Message 1

Committees 2

Oral and Poster Session Presentation Guidance 4-5

Poster Competition 5

Corporate Sponsors and Media Partners 6

Conference History 6

General Information 7

Sunday Workshops and Monday Tutorial Program 8

Free Vendor Workshops 9

At-a-glance List of Sponsors, Exhibitors, Media 10

Scientific Program 11-27

List of Exhibitors 28-33

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PREP 2016 Final Program Page 4

Oral and Poster Session Presentation Guidance AUTHOR INDEX The Author Index is located in the back of the Final Program book.

"L" preceding the abstract number = Lecture "P" preceding the abstract number = Poster To locate your paper number, please refer to the Author Index located in the back of the Final Program Book.

KEY TO First Symbol P = Poster Presentation P-M-200

POSTER BOARD L = Lecture Presentation L-M-100

& ABSTRACT

NUMBERS Second Symbol Day to present poster P-T-200

M = Monday T = Tuesday

Last Symbol Poster Presentation Number P-M-100

Lecture Presentation Number L-200 ORAL PRESENTERS Prior to the start of each session, please arrive at your session at least 20

minutes before the start of the session to introduce yourself to the session chair and to submit your presentation on a flash drive labeled with the presenter’s name. Important to note that if there is no time to submit your presentation between sessions, please submit the presentation during the break that immediately precedes your session.

Please come to the podium and get your presentation set up during the question period for the previous talk.

Kindly note that session chairs are under very strict instructions to keep their sessions on schedule.

POSTER PRESENTERS Details regarding set-up, presentation, and tear-down days and times:

ALL posters in Poster Sessions I and II should be put up on Monday, July 18, between 8:30 AM and 1:00 PM and remain on the poster boards for participants to view both days (do not remove until Tuesday between 3:15 PM to 6:00 PM).

Be sure to remove the reprint envelope where people leave business cards to request reprints of your abstract – anything remaining after 6:00 PM will be discarded.

Poster presentations are numbered in the scientific program to correspond with the poster board number.

To verify your poster board number, please refer to the Author Index located in the back of the Final Program.

Presenters must be in attendance at their posters on the day and time of their poster presentations.

Authors of posters in the P-100 series should stand at their posters and be available to discuss the research during Poster Session I on Monday from 2:00 PM to 3:15 PM.

Authors of posters in the P-200 series should stand at their posters and be available to discuss the research during Poster Session II on Tuesday from 2:00 PM to 3:15 PM.

Remove all posters from the poster boards only on Tuesday between 3:15-6:00 PM. Anything remaining on the poster boards after 6:00 PM will be discarded.

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PREP 2016 Final Program Page 5

Poster Session Presentation Guidance POSTER SET UP – ALL posters must be set up on Monday, between 8:30 AM to 1:00 PM.

– ALL posters stay up on the poster boards for two days (do NOT remove until the end of the day on Tuesday).

POSTER TEAR DOWN – Only remove posters from the poster boards on Tuesday between 3:15-6:00 PM.

POSTER SESSIONS – Posters are located in the Millennium Exhibit Hall, 2nd floor. – Poster board numbers correspond to the poster presentation numbers in the Final Program. – Authors presenting posters are required to be in attendance at their poster board during the Poster Session on the day/time of their poster presentation. – Reprint envelopes are attached to the poster boards. To request reprints of

poster abstracts, please insert your business card in the envelope. Each day, poster presenters should look in their reprint envelopes to retrieve any business cards that may be inside the envelope.

– Leave the poster on the poster board for 2 days; do not remove until Tuesday.

Best Poster Competition POSTER Poster presentations are a very important component of the PREP Symposia. COMPETITION In order to acknowledge their contribution to the field and high standards of the

symposium, awards will be offered to distinguish the best poster contributions at PREP 2016. Posters will be evaluated on the basis of scientific content, clarity of presentation, and layout. Posters co-authored by members of the Scientific and Industrial Advisory Committees or by judges are eligible only if the main author and presenter of the poster is not a member on the above committees. Posters authored or co-authored by members of the Organizing Committee or judges are not eligible for Best Poster Awards. However, should these posters be considered of sufficient quality to be among the top prize-winning entries, they will be given an Honorable Mention. The Poster Judging Committee will have final say in the selection of the Prize Winners. At least two committee members will read each poster and top posters will be read by at least four committee members. If a poster author does not want his/her poster considered for a poster award, they must notify the Symposium Manager before 11:00 a.m. on Tuesday, July 19.

Wednesday Presentation of awards to winners of the Best Poster Competition will take place

at the end of the Wednesday morning sessions at 12:30-12:40 PM. The winners are encouraged to be present, but it is not mandatory to be present to win.

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PREP 2016 Final Program Page 6

Thank you to our Corporate Sponsors

Thank you to our Media Partners

PREP Symposium Conference History

1985 Washington DC 2002 Washington DC

1986 Washington DC 2003 San Francisco, CA

1987 Washington DC 2004 Baltimore, MD

1989 Washington DC 2005 Philadelphia, PA

1991 Washington DC 2006 Washington DC

1993 Washington DC 2007 Washington DC

1994 Washington DC 2008 San Jose, CA

1995 Washington DC 2009 Philadelphia, PA

1996 Washington DC 2010 Philadelphia, PA

1997 Washington DC 2011 Cambridge, MA

1998 Washington DC 2012 Cambridge, MA

1999 San Francisco, CA 2013 Boston, MA

2000 Washington DC 2014 Boston, MA

2000 Washington DC 2015 Philadelphia, PA

2001 Washington DC 2016 Philadelphia, PA

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PREP 2016 Final Program Page 7

General Information

VENUE Loews Philadelphia Hotel 1200 Market Street, Philadelphia, PA 19107, USA

Phone 215-627-1200 http://www.loewshotels.com/philadelphia-hotel/

NAME BADGES A name badge must be worn by each registered participant and accompanying

person in order to gain admittance to the meeting, exhibit halls and social gatherings. You must wear your official conference name badge (no badge sharing), and your name and name badge must be visible at all times, in order to enter, and while you are inside, the meeting rooms and exhibition hall. Persons without a visible name badge, or with a badge that is not their own name badge, will be escorted out of the meeting room or exhibition hall.

REGISTRATION Symposium Registration is located near Commonwealth Hall, 2nd floor EXHIBITS The Exhibition is an important component of the meeting, so please take the

time to thank all the exhibitors for their support of the program by visiting the booths located in Millennium Hall, 2nd floor.

EXHIBIT HOURS Sunday 6:00 PM 7:30 PM

Monday 10:15 AM 5:15 PM

Tuesday 9:20 AM 3:30 PM SOCIAL Sunday Welcome Reception 6:00 PM - 7:30 PM Millennium Hall, 2nd floor NETWORKING Monday Mixer 12:30 PM - 3:20 PM Millennium Hall, 2nd floor

Tuesday Mixer 12:30 PM - 3:20 PM Millennium Hall, 2nd floor Wednesday Farewell Reception 4:50 PM - 5:50 PM Commonwealth Foyer, 2nd floor

MESSAGE AND The Message and Job Posting board is located on the 2nd floor JOB POSTINGS between the Commonwealth and Millennium Halls. BOARD

The use of still or video cameras and cell phones is prohibited during the oral program; and prohibited in the poster and exhibition areas without the express consent of the presenter or exhibitor. Opinions expressed by presenters, instructors and exhibitors are not necessarily the opinions of the PREP 2016 Symposium. You must wear your official conference name badge (no badge sharing), and your name and name badge must be completely visible at all times, in order to enter, and while you are inside, the meeting rooms and exhibition hall. Persons without a visible name badge, or with a badge that is not their own name badge, will be escorted out of the meeting room or exhibition hall.

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PREP 2016 Final Program Page 8

Sunday Workshops and Monday Tutorial Training Program

Sunday, July 17 Workshops (separate registration fee) Instructors

9:00am-12:30pm Commonwealth Hall A1

Fundamentals of Preparative Chromatography for Biomolecule Purification by Batch and Continuous Processes Focus on biomolecule chromatography, stationary phases, binding capacity and selectivity, mass transfer, modeling, design for capture and resolution, multicolumn and continuous chromatography processes.

Giorgio Carta, University of Virginia Alan Hunter, MedImmune Alois Jungbauer, BOKU, Vienna Massimo Morbidelli, ETH Zurich

12:30pm-4:00pm Commonwealth Hall A2

Fundamentals of Preparative Chromatography for Purification of APIs, Peptides, and Oligonucleotides by Batch Chromatography, SMB, and SFC Focus on small molecule pharmaceuticals, APIs, chiral molecules, peptides, oligonucleotides, HPLC, column packing, gradient elution, overloaded chromatography, continuous chromatography, SMB, SFC, examples and industrial applications.

Olivier Dapremont, Ampac Fine Chemicals

4:00pm-6:30pm Commonwealth Hall A1

Regulatory Fundamentals, QbD, and Design of Experiments for Biopharmaceuticals Focus on regulatory aspects, QbD/DOE principles and practical examples, Process Analytical Technology, Quality System Management, biosimilars.

Lois Ann Beaver, LAB Enterprises Gisela Ferreira, MedImmune

Monday, July 18 Tutorial (separate registration fee) Instructors

7:00am-8:30am Commonwealth Hall A1

Tips, Tricks, and Troubleshooting Analytical and Overloaded Prep Chromatography Focus on analytical chromatography, overloaded chromatography, HPLC, SFC, examples of small molecules, APIs, peptides.

Cecilia Mazza, AkzoNobel Tony Yan, Pfizer, Inc.

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PREP 2016 Final Program Page 9

Monday Free Vendor Workshops must pre-register on Monday by 10:50 AM

Monday Free Vendor Workshop sponsored by Purolite Life Sciences 12:45-2:00 PM A Bead for Every Need, from MAb Purification to Uranium Extraction

Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Purolite by Monday @ 10:50 AM

Monday Free Vendor Workshop sponsored by Bio-Rad Laboratories 12:45-2:00 PM Utilizing Novel Mixed-Mode Selectivities for Challenging Chromatography

Separations Location: Commonwealth Hall A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of Bio-Rad Laboratories by Monday @ 10:50 AM

Monday Free Vendor Workshop sponsored by DAISO Fine Chem USA, Inc. 12:45-2:00 PM Re-evaluation of the CIP Step in Insulin-related RP HPLC Processes

Location: Commonwealth Hall A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of DAISO Fine Chem USA by Monday @ 10:50 AM

Tuesday Free Vendor Workshops must pre-register on Monday by 5:00 PM

Tuesday Free Vendor Workshop sponsored by AkzoNobel/Kromasil 12:45-2:00 PM Latest Developments of Stationary Phases for Preparative Chromatography

Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of AkzoNobel/Kromasil by Monday @ 5:00 PM

Tuesday Free Vendor Workshop sponsored by Thermo Fisher Scientific 12:45-2:00 PM Enabling Custom Solutions for Downstream Processing for Future Therapies

Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of Thermo Fisher Scientific by Monday @ 5:00 PM

Tuesday Free Vendor Workshop sponsored by Itochu Chemicals America/Mitsubishi Chemical 12:45-2:00 PM Bioseparation Media by Mitsubishi Chemical

Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Itochu Chemicals America by Monday @ 5:00 PM

Tuesday Free Vendor Workshop sponsored by GE Healthcare Life Sciences 12:45-2:00 PM Affinity Chromatography—Protein A Improvements and Beyond

Location: Tubman Room, must take elevator to 3rd floor (light lunch will be provided) Must pre-register at GE Healthcare's Poster # P-T-218 by Monday @ 5:00 PM

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PREP 2016 Final Program Page 10

At-a-glance List of Sponsors, Exhibitors, Media Partners

Agilent Technologies

AkzoNobel/Kromasil

American Laboratory

American Pharmaceutical Review

Ampac Fine Chemicals

Avantor Performance Materials

Bioanalysis-Zone

BioProcessing Journal

Bio-Rad Laboratories

Bristol-Myers Squibb

CC Biotech

DAISO Fine Chem USA

Essential Life Solutions & emp Biotech

GE Healthcare Life Sciences

Genentech

GENews

GlaxoSmithKline

International LabMate/Chromatography Today

ITOCHU Chemicals America

JASCO

JNC America

JSR Life Sciences

Kaneka

Lab Manager Magazine

LabCompare

LCGC

MedImmune

Merck

NOVASEP

Pfizer

PIC Solution

Purolite Life Sciences

Quantum Analytics

Semba Biosciences

Separation Methods Technologies

Separation Science

Shire

SP Scientific-Genevac

Thermo Fisher Scientific

YMC America

YPSO-FACTO

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PREP 2016 Final Program 11

Sunday, July 17, 2016 9:00 AM - 12:30 PM Workshop 1 on Fundamentals of Preparative Chromatography for Commonwealth A1 Biomolecule Purification by Batch and Continuous Processes

Must pre-register to attend 12:30 PM - 4:00 PM Workshop 2 on Fundamentals of Preparative Chromatography for Commonwealth A2 Purification of APIs, Peptides, and Oligonucleotides by Batch

Chromatography, SMB, and SFC Must pre-register to attend

4:00 PM - 6:30 PM Workshop 3 on Regulatory Fundamentals, QbD, and Design of Commonwealth A1 Experiments for Biopharmaceuticals

Must pre-register to attend 1:00 - 5:30 PM Registration for Exhibitors Only to set up booth Location: Commonwealth Hall Foyer, 2nd floor

6:00 - 7:30 PM Symposium Registration Open for Conferees

Location: Commonwealth Hall Foyer, 2nd floor

6:00 - 7:30 PM Grand Opening of the Exhibition & Welcome Reception Location: Millennium Hall, 2nd floor Open to all conference participants; conference name badge is required for entry.

Monday, July 18, 2016 7:00 AM - 8:30 AM Tutorial on Tips, Tricks, and Troubleshooting Analytical and Commonwealth A1 Overloaded Prep Chromatography

Must pre-register to attend

7:45 AM - 5:15 PM Symposium Registration Open

Location: Commonwealth Hall Foyer, 2nd floor

10:00 AM - 5:15 PM Exhibition Open in Millennium Hall, 2nd floor

8:30 AM WELCOME AND OPENING REMARKS Giorgio Carta, University of Virginia, Charlottesville, VA, USA

Location: Commonwealth Hall C/D, 2nd floor

1. Monday Keynote: Industrial Case Studies in Protein Chromatography Session Chairs: Giorgio Carta, University of Virginia, Alan Hunter, MedImmune, Gaithersburg, MD, USA Location: Commonwealth Hall C/D, 2nd floor

8:40 AM (L-101) Development of a Semi-continuous, Integrated Chromatography

Purification Platform for Perfusion and High Titer Fed Batch Antibody Production. Rebecca Chmielowski, Darshini Shah, Collette Cutler, Hong Li, David Roush, Nihal Tugcu, Merck, Kenilworth, NJ, USA

9:00 AM (L-102) Mechanistic Investigation of Aggregate Formation in CEX and Mitigation

Strategy for an Unstable Fc-fusion Protein. Zhiqiang Chen, Chao Huang, Naresh Chennamsetty, Xuankuo Xu, ZhengJian Li, Bristol-Myers Squibb, Devens, MA, USA

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PREP 2016 Final Program 12

Monday, July 18, 2016 9:20 AM (L-103) A New Approach to Assess the Process Clearance Capability for Critical

Quality Attributes. Kathlyn Lazzareschi, Josefine Persson, Genentech A member of Roche, South San Francisco, CA, USA

9:40 AM (L-104) High Resolution Preparative Protein Separation using Novel pH Gradients

Employing Simple Buffer Systems. Matthew Herigstad, Lihua Yang, Natarajan Ramasubramanyan, AbbVie, Westborough, MA, USA

10:00 AM (L-105) Purification of Recombinant Polyclonal Antibody (rpAb) Mixtures: Impact

of Polishing Modality on Aggregate Selectivity and mAb Component Ratios. Alan Hunter, Frank Bartnik, Hongji Liu, Xiangyang Wang, Timothy Pabst, MedImmune, Gaithersburg, MD, USA

10:20-10:50 AM Break in Millennium Exhibit Hall, 2nd floor

2. Monday Keynote: Continuous Chromatography Session Chairs: Kathleen Mihlbachler, LEWA Process Technologies, Devens, MA, USA, Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA Location: Commonwealth Hall C/D, 2nd floor

10:50 AM (L-106) Continuous Multicolumn Purification of Therapeutic Proteins.

Fabian Steinebach, Daniel Baur, Nicole Ulmer, Lara Decker, Massimo Morbidelli, ETH Zurich, Zurich, SWITZERLAND

11:10 AM (L-107) Continuous Purification Platforms for Viral Vectors based on Multicolumn

Simulated Countercurrent Chromatography. Ricardo Silva1, Cristina Peixoto

1, Manuel

Carrondo1, Jose Mota

2,

1IBET, Oeiras, PORTUGAL;

2FCT-UNL & IBET, Caparica,

PORTUGAL 11:30 AM (L-108) Model-based Conversion of a Single-column Batch Process to 3- and 4-

Column Periodic Counter-current Chromatography. Tobias Hahn, Thiemo Huuk, Fabian Gorlich, Gang Wang, Jurgen Hubbuch, KIT, Karlsruhe, GERMANY

11:50 AM (L-109) Model Predictive Control of 4-zone Simulated Moving Bed Chromatography

using a Decoupled and Simplified Process Model. Ju Weon Lee, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

12:10-12:30 PM (L-110) A Rationale Approach for Comparing Different Affinity Chromatographic

Processes for the Capture of a Monoclonal Antibody. Roger-Marc Nicoud1, Laurent

David1, Margit Holzer

1, Jay Yun

2,

1Ypso-Facto, Nancy, FRANCE;

2Ypso-Facto,

Cambridge, MA, USA

Monday Mixer in the Exhibition Hall Location: Millennium Hall, 2nd floor - Mixer includes light lunch

12:30-3:20 PM Break, Exhibits, Posters

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PREP 2016 Final Program 13

Monday, July 18, 2016

Monday Free Vendor Workshops Must pre-register at the sponsor's booth to attend; light lunch will be provided

12:45-2:00 PM A Bead for Every Need, from MAb Purification to Uranium Extraction,

sponsored by Purolite Life Sciences Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Purolite Life Sciences by Monday @ 10:50 AM

12:45-2:00 PM Utilizing Novel Mixed-Mode Selectivities for Challenging Chromatography

Separations, sponsored by Bio-Rad Laboratories Location: Commonwealth Hall A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of Bio-Rad Laboratories by Monday @ 10:50 AM

12:45-2:00 PM Re-evaluation of the CIP Step in Insulin-related RP HPLC Processes,

sponsored by DAISO Fine Chem USA, Inc. Location: Commonwealth Hall A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of DAISO Fine Chem USA by Monday @ 10:50 AM

MONDAY POSTER SESSION I Poster Session Chair: Dorota Antos, Rzeszow University of Technology, Poland Location: Millennium Exhibition Hall, 2nd floor

2:00-3:15 PM POSTER SESSION I - Sponsored by Bristol-Myers Squibb

Location: Millennium Exhibit Hall, 2nd floor

3A. Monday Parallel Session: Strategies and Processes for Biomolecule Purification Session Chair: Abraham Lenhoff, University of Delaware, Newark, DE, USA Location: Commonwealth Hall C/D, 2nd floor

3:20 PM (L-111) Purification of Secretory Immunoglobulins by Chromatographic Methods.

Hannah Engelmaier, Alexander Matlschweiger, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA

3:40 PM (L-112) Resolution of Positional Isomers of Exenatide Mono-PEGylates by Prep

Chromatography. Thi Ngoc Thanh Nguyen, Soi Yoon, E. K. Lee, Hanyang University, Ansan, SOUTH KOREA

4:00 PM (L-113) Heat Precipitation of Tobacco Host Cell Proteins Facilitates Target Protein

Recovery and Purification and Can be Implemented into an Automated Large-scale Manufacturing Process. Stephan Menzel, Rainer Fischer, Johannes Buyel, Fraunhofer IME, Aachen, GERMANY

4:20 PM (L-114) Optimizing Recombinant F(ab)2 Purification for Improved PET Imaging of

Cancer Biomarkers. Mark Fitchmun1, Kimberly Fitchmun

1, Ritsuko Sawada

2, Wolfgang

Scholz2,

1Somatek Inc., San Diego, CA, USA;

2MabVax Therapeutics, San Diego, CA,

USA

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

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PREP 2016 Final Program 14

Monday, July 18, 2016

3B. Monday Parallel Session: Stationary Phases 1 Session Chairs: Shuichi Yamamoto, Yamaguchi University, Japan and Conan Fee, Canterbury University, New Zealand Location: Commonwealth Hall B, 2nd floor

3:20 PM (L-115) High Performance, Rapid Separation, and High Loading Capacity of the

Novel Stationary Phase using Dual-pore Silica Beads in Reversed Phase Liquid Chromatography. Hong-zhi Bai

1, Riichi Miyamoto

1, Akie Kawamura

2, Mika Watanabe

2,

Teruhiko Kanno2, Takashi Ohtani

2, Kazuki Nakanishi

3,

1SnG Inc., Kyoto, JAPAN;

2Hamari

Chemicals Ltd., Osaka, JAPAN; 3Kyoto University, Kyoto, JAPAN

3:40 PM (L-116) Design and Evaluation of Advanced Amsphere™ A3 Protein A

Chromatography Resin: The Relationships and Considerations of Bead structure, Pore Structure, Surface Chemistries and Ligand Design on Affinity Resin Performance Targets. Satoshi Nakamura

1, Alpana Naresh

2, Tomonori Shiotani

1, Marty

Siwak2,

1JSR Micro, Durham, NC, USA;

2JSR Micro, Sunnyvale, CA, USA

4:00 PM (L-117) Reducing Cost of Clinical Trials through the use of Novel Alkali Stable

Protein A Resins. Hans Berg1, Mark Hicks

2, Caroline Tinsley

2, Patrick Gilbert

2, Charlotte

Vassay-Jones2, Hans J. Johansson

1,

1Purolite, Uppsala, SWEDEN;

2Purolite, Llantrisant,

WALES 4:20 PM (L-118) Single and Multi-component IgG Adsorption on Protein A Chromatography

Resins. Justin Weinberg1, Shaojie Zhang

2, Giorgio Carta

2, Todd Przybycien

1,

1Carnegie

Mellon University, Pittsburgh, PA, USA; 2University of Virginia, Charlottesville, VA, USA

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

4A. Monday Parallel Session: Monoliths and Membrane Chromatography Session Chair: Ales Podgornik, COBIK, Ljubljana, Slovenia Location: Commonwealth Hall C/D, 2nd floor

(L-119) withdrawn 5:10 PM (L-120) Rapid Protein Ion-exchange Separations using Surface Modified Nylon

Capillary-channeled Polymer (C-CP) Fibers. Liuwei Jiang, R. Kenneth Marcus, Clemson University, Clemson, SC, USA

5:30 PM (L-121) Optimization of Continuous Countercurrent Tangential Chromatography

(CCTC) for Continuous Purification of Monoclonal Antibodies. Oleg Shinkazh1,

Andrew Zydney2,

1ChromaTan, State College, PA, USA;

2Penn State University, State

College, PA, USA 5:50 PM Pause

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PREP 2016 Final Program 15

Monday, July 18, 2016

4B. Monday Parallel Session: Stationary Phases 2 Session Chairs: Shuichi Yamamoto, Yamaguchi University, Japan and Conan Fee, Canterbury University, New Zealand Location: Commonwealth Hall B, 2nd floor

5:10 PM (L-122) Mixed Mode Chromatography in Non-affinity based Purification Schemes.

Carsten Voss, Bio-Rad Laboratories GmbH, Munich, GERMANY (L-123) withdrawn

5:30 PM (see also poster P-T-220) Adsorption and Separation of Native and PEGylated

Proteins on Anion Exchange Resins with Varying Length of Polymer Grafting. Mimi Zhu, Preston Fuks, Giorgio Carta, University of Virginia, Charlottesville, VA, USA

5:50 PM (L-124) Dual Flow Chromatography for Parallel, Automated, High Throughput

Process Development. Douglas Gjerde, Christopher Suh, Lee Hoang, PhyNexus Inc., San Jose, CA, USA

6:10 PM Pause

Tuesday, July 19, 2016

7:30 AM - 5:15 PM Symposium Registration Open

Location: Commonwealth Hall Foyer, 2nd floor

9:00 AM - 3:30 PM Exhibition Open in Millennium Hall, 2nd floor

5. Tuesday Keynote: Preparative Chromatography in Drug Discovery, Development, and Manufacture Session Chair: Tony Yan, Pfizer, Groton, CT, USA Location: Commonwealth Hall C/D, 2nd floor

8:00 AM (L-201) Liquid Carbon Dioxide Flash: Has the Myth Become Reality.

Ray McClain, Merck, West Point, PA, USA 8:20 AM (L-202) Design (and Avoidance) of Process-scale Chromatography through the use

of Statistical Design of Experiments. Teri Hochdorfer, Fangfang Liu, Ke Wang, Glenn Wilcox, Pfizer, Groton, CT, USA

8:40 AM (L-203) Dual Purpose Analytical SFC/UHPLC Instrument with On-line SFE

Capability for Automated Method Screening of Chiral and Achiral Separations. Robert Buco

1, Masayuki Nishimura

2, Yosuke Iwata

3, Kenichiro Tanaka

4,

1Shimadzu

Corporation, Marlborough, MA, USA; 2Shimadzu Corporation, Columbia, MD, USA;

3Shimadzu Corporation, Kyoto, JAPAN;

4Shimadzu Scientific Instruments Inc., Columbia,

MD, USA 9:00 AM (L-204) Chromatography as the Multi-tool of Drug Development and its Preparative

Chiral Attachment. J. Preston, Michael McCoy, Phenomenex, Torrance, CA, USA

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

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PREP 2016 Final Program 16

Tuesday, July 19, 2016

6. Tuesday Session: Understanding and Modeling Biomolecule Chromatography Session Chair: David Roush, Merck & Co., Inc., Kenilworth, NJ, USA Location: Commonwealth Hall C/D, 2nd floor

9:50 AM (L-205) Molecular Modeling Technique for Protein-surface Binding Free Energy

Calculation and Prediction of Elution Behavior in Multimodal Chromatography. Suvrajit Banerjee, Shekhar Garde, Steven Cramer, Rensselaer Polytechnic Institute, Troy, NY, USA

10:10 AM (L-206) Probing Nanoscale Effects of Ligand Density in Tentacular Ion Exchangers

using X-ray Scattering. Rahul Bhambure1, Daniel Greene

1, Yun Liu

1, Christopher

Gillespie2, Michael Phillips

2, Heiner Graalfs

3, Almut Rapp

3, Abraham Lenhoff

1,

1University

of Delaware, Newark, DE, USA; 2MilliporeSigma, Bedford, MA, USA;

3Merck Millipore,

Darmstadt, GERMANY 10:30 AM (L-207) Effect of Isotherm Nonlinearity on Protein Binding and Elution in

Hydrophobic Interaction and Multimodal Chromatography. Renata Muca, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND

10:50 AM (L-208) Influence of Mixed Electrolytes and pH on Adsorption of Proteins in

Hydrophobic Interaction Chromatography. Eva Hackemann, Hans Hasse, University of Kaiserslautern, Kaiserslautern, GERMANY

7. Tuesday Session: Innovative Materials and Processes for Biochromatography Session Chair: Kathlyn Lazzareschi, Genentech, South San Francisco, CA, USA Location: Commonwealth Hall C/D, 2nd floor

11:10 AM (L-209) Fluid Dynamics Simulation based on 3D pore Structure of Macro Porous

Monoliths Shows High Permeability Due to Alternating Channel Width. Alois Jungbauer

1, Christian Jungreuthmayer

2, Petra Gerster

1,

1BOKU, Vienna, AUSTRIA;

2acib, Vienna, AUSTRIA

11:30 AM (L-210) Optimization of Porous Bed Geometric Features to Maximize Adsorption of

Proteins and Passage of Suspended Solids in a 3D-printed Adsorption Column. Conan Fee

1, Felix Newberry

1, Anne Gordon

1, Philip Wilson

1, Miguel Moyers-Gonzalez

1,

Rua Murray1, Tim Huber

1, Simone Dimartino

2,

1University of Canterbury, Christchurch,

NEW ZEALAND; 2University of Edinburgh, Edinburgh, SCOTLAND

11:50 AM (L-211) A Scaleable Integrated System for Temperature-controlled Fast Protein

Liquid Chromatography. Owen R.T. Thomas1, Eirini Theodosiou

2, Matthias Franzreb

3,

1University of Birmingham, Birmingham, UK;

2Aston University, Birmingham, UK;

3Karlsruhe Institute of Technology, Eggenstein-Leopoldshafen, GERMANY

12:10-12:30 PM (L-212) Modeling of Linear pH and Salt Gradient Elution on Weak Cation Exchange

Resins. Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY

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PREP 2016 Final Program 17

Tuesday, July 19, 2016

Tuesday Mixer in the Exhibition Hall Location: Millennium Hall, 2nd floor -- Mixer includes light lunch

12:30-3:20 PM Break, Exhibits, Posters

Tuesday Free Vendor Workshops Must pre-register at the sponsor's booth to attend; light lunch will be provided

12:45-2:00 PM Latest Developments of Stationary Phases for Preparative Chromatography,

sponsored by AkzoNobel/Kromasil Location: Commonwealth A1, 2nd floor (light lunch will be provided) Must pre-register at the booth of AkzoNobel/Kromasil by Monday @ 5:00 PM

12:45-2:00 PM Enabling Custom Solutions for Downstream Processing for Future Therapies, sponsored by Thermo Fisher Scientific

Location: Commonwealth A2, 2nd floor (light lunch will be provided) Must pre-register at the booth of Thermo Fisher Scientific by Monday @ 5:00 PM

12:45-2:00 PM Bioseparation Media by Mitsubishi Chemical,

sponsored by Itochu Chemicals America/Mitsubishi Chemical Location: Commonwealth Hall B, 2nd floor (light lunch will be provided) Must pre-register at the booth of Itochu Chemicals America by Monday @ 5:00 PM

12:45-2:00 PM Affinity Chromatography—Protein A Improvements and Beyond,

sponsored by GE Healthcare Life Sciences Location: Tubman Room, must take elevator to 3rd floor (light lunch will be provided) Must pre-register at GE Healthcare's Poster # P-T-218 by Monday @ 5:00 PM

TUESDAY POSTER SESSION II Poster Session Chair: Dorota Antos, Rzeszow University of Technology, Poland Location: Millennium Exhibition Hall, 2nd floor

2:00-3:15 PM POSTER SESSION II - Sponsored by Bristol-Myers Squibb

Location: Millennium Exhibit Hall, 2nd floor

8A. Tuesday Parallel Session: New Developments in Affinity Chromatography Session Chair: Rainer Hahn, BOKU, Vienna, Austria Location: Commonwealth Hall C/D, 2nd floor

3:20 PM (L-213) Making Protein A Media Stealthy. Todd Przybycien, Justin Weinberg, Carnegie

Mellon University, Pittsburgh, PA, USA (L-214) withdrawn 3:40 PM (L-216) Development of a Continuous Protein A Capture Unit Operation: How

Resin Characteristics Change the Multi-column Process. Nicolas-Julian Hilbold1,

Xavier Le Saout2, Eric Valery

3, Jonathan Souquet

2, Laurence Muhr

4,

1Novasep, Pompey,

FRANCE; 2Merck KGaA, Corsier-sur-Vevey, SWITZERLAND;

3Novasep, Lyon, FRANCE;

4LRGP (Reactions and Process Engineering Laboratory), Nancy, FRANCE

4:00-4:20 PM (L-215) A Platform for the Development of Affinity Peptide Resins for Capture and

Downstream Purification of Non-mAb Biologics. Divya Chandra, Steve Timmick, Chaz Goodwine, Nick Vecchiarello, Pankaj Karande, Steven Cramer, Chemical & Biological Engineering Rensselaer Polytechnic Institute, Troy, NY, USA

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PREP 2016 Final Program 18

Tuesday, July 19, 2016

8B. Tuesday Parallel Session: New Developments and Applications of Continuous Chromatography Session Chair: Attila Felinger, University of Pecs, Hungary Location: Commonwealth Hall B, 2nd floor

3:20 PM (L-217) Demonstration of a mAb Chromatography Platform Process Operating in a

Continuous and Integrated Mode: Flexibility for Facility Fit and Process Economics Optimization. Xhorxhi Gjoka, Rene Gantier, Mark Schofield, Pall Life Sciences, Westborough, MA, USA

3:40 PM (L-218) Separation of Astaxanthin from the Crude Extract of Haematococcus

Pluvialis by Simulated Moving Bed. Xiao-Qing Bao, Wen-Tung Wu, Chih-Hsiung Lin, Ya-Ting Shih, Ming-Tsai Liang, I-Shou University, Kaohsiung, TAIWAN

4:00 PM (L-219) Large Scale (Ton Scale) Purification of Plant Derived Proteins using

Simulated Moving Bed Chromatography. Anil Oroskar, Pravin Ninanwe, Babu Antharawalli, Priyanka Oroskar, Orochem Technologies Inc., Naperville, IL, USA

4:20-4:40 PM (L-220) An Integrated UV-VIS Detection Module for MCC in Achiral Separations.

Gary Yanik1, Leo Hsu

2, Xiqin Yang

2,

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

2GlaxoSmithKline, King of Prussia, PA, USA

9A. Tuesday Parallel Session: Column Characterization Session Chair: Igor Quinones-Garcia, Shire, Lexington, MA, USA Location: Commonwealth Hall C/D, 2nd floor

4:50 PM (L-221) Measurement and Modeling of Extra Column Volume and System Band

Broadening for Scale-up of Preparative Chromatography Columns. Susanne Schweiger

1, Christian Jungreuthmayer

1, Tim Schröder

2, Alois Jungbauer

3,

1Austrian

Centre of Industrial Biotechnology, Vienna, AUSTRIA; 2Atoll GmbH, Weingarten,

GERMANY; 3University of Natural Resources and Life Sciences, Vienna, AUSTRIA

5:10 PM (L-222) Characterization and Application of Microliter Disposable Monolithic

Columns (DMC) for PAT. Tanja Lukan1, Shuichi Yamamoto

2, Noriko Yoshimoto

3, Ales

Podgornik1,

1 COBIK, Ljubljana, SLOVENIA; 2Yamaguchi University, Ube, JAPAN;

3Ube,

JAPAN 5:30 PM (L-223) Chromatographic Column Transition Analysis using Moment Analysis.

Brian Youchak1, Willis Bell

2,

1Eli Lilly and Company, Branchburg, NJ, USA;

2Eli Lilly and

Company, Indianapolis, IN, USA 5:50 PM (L-224) Planning the Execution of a Viral Clearance Study: Right First Time.

Douglas Rea, Katherine Bergmann, Eurofins Lancaster Labs, Lancaster, PA, USA

6:10 PM Pause

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PREP 2016 Final Program 19

Tuesday, July 19, 2016

9B. Tuesday Parallel Session: Advances in Chromatographic Modalities for Bioprocess Applications Session Chair: Christian Frech, Mannheim University of Applied Sciences, Germany Location: Commonwealth Hall B, 2nd floor

4:50 PM (L-225) Flow Through Chromatography and Absorptive Depth Filtration for

Continuous Bioprocessing Applications – Case Studies. Romas Skudas, Paul Beckett, Merck KGaA, Darmstadt, GERMANY

5:10 PM (L-226) SMART Chromatography - A Method for Packed Bed Purification from Cell

Containing Feedstreams. Alistair Hurst, Derek Levison, Ruediger Welz, Franziska Meier-Haettig, emp Biotech GmbH, Berlin, GERMANY

5:30 PM (L-227) Purification of Acidic Proteins with Ceramic Hydroxyapatite: Bind-and-

Elute Mode or Flow-through Mode? Xuemei He, Louisa Vang, Bio-Rad Laboratories, Hercules, CA, USA

5:50 PM (L-228) Bridging the Gap Between Analytical and Process Protein A

Chromatography. J. Kevin O'Donnell1, Atis Chakrabarti

1, William Evans

1, Kosuke Araki

2,

Shigeru Nakatani2,

1Tosoh Bioscience LLC, King of Prussia, PA, USA;

2Tosoh

Corporation, Shunan, JAPAN

6:10 PM Pause

Wednesday, July 20, 2016

7:30 AM Symposium Registration Open

10. Wednesday Keynote: Preparative Supercritical Fluid Chromatography (SFC) Session Chairs: Lois Beaver, LAB Enterprises, Chevy Chase, MD, USA and Jonathan Edelman, Washington Chromatography Discussion Group Location: Commonwealth Hall A/B, 2nd floor

8:00 AM (L-301) Operating Large Diameter Columns in Liquid and Supercritical Fluid

Chromatography under Strictly Adiabatic Thermal Environment. Fabrice Gritti, Joseph Jarrell, Martin Gilar, Waters Corporation, Milford, MA, USA

8:20 AM (L-302) Stationary Phase Selection for Optimized Preparative SFC

Chromatography. Matthew Przybyciel, ES Industries, West Berlin, NJ, USA 8:40 AM (L-303) Advances in Preparative Gas-expanded Liquid Chromatography.

Jerome Boni1, Celine Morey

1, Jin Seok Hur

2, Yvan Ruland

3,

1Novasep, Pompey,

FRANCE; 2Novasep, Boothwyn, PA, USA;

3Novasep, Shanghai, CHINA

9:00 AM (L-304) Reliable Scale-up from Linear Gradient Screening to Isocratic Bulk-

purification in SFC. Jason Hill, Abhijit Tarafder, Waters, Milford, MA, USA 9:20-9:40 AM (L-305) Peak Distortions in Supercritical Fluid Chromatography due to Adsorption

of the Co-solvent. Torgny Fornstedt1, Emelie Glenne

1, Jörgen Samuelsson

1, Hanna

Leek2, Kristina Ohlen

2, Magnus Klarqvist

2,

1Karlstad University, Karlstad, SWEDEN;

2AstraZeneca R&D Molndal, Molndal, Sweden

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PREP 2016 Final Program 20

Wednesday, July 20, 2016

11. Wednesday Keynote: Preparative Purification of Peptides Session Chairs: Olivier Dapremont, AMPAC Fine Chemicals, Rancho Cordova, CA, USA, Marc Jacob, Phenomenex, Torrance, CA, USA Location: Commonwealth Hall A/B, 2nd floor

9:40 AM (L-306) State-of-the-Art Purification of Peptide APIs: Challenges and

Achievements. Georg M. Sambeth1, Günther Loidl

2, Ralph Schönleber

1,

1Bachem AG,

Bubendorf, SWITZERLAND; 2Bachem Holding, Bubendorf, SWITZERLAND

10:00 AM (L-307) Chemically Stable Merged Organic/Inorganic Silica Material for

Purifications of Peptides and Proteins in Reversed Phase Preparative Chromatography. Fredrik Lime, Cecilia Mazza, AkzoNobel/Kromasil, Bohus, SWEDEN

10:20 AM (L-308) Influence of Column Overloading on Selectivity in Peptide Purification.

Guido Krautz1, Tivadar Farkas

2, Marc Jacob

2,

1Phenomenex Ltd., Aschaffenburg,

GERMANY; 2Phenomenex Inc., Torrance, CA, USA

10:40-10:50 AM Presentation of Awards to Winners of the Best Poster Competition

10:50-11:10 AM Break in Commonwealth Foyer, 2nd floor

12. Wednesday Session: Chromatography for Virus Particles Session Chair: Alois Jungbauer, BOKU, Vienna, Austria Location: Commonwealth Hall A/B, 2nd floor

11:10 AM (L-309) Combining Solute Surface Analytics and High Throughput Screening to

Define Binding Mechanisms of Virus Particles to Multimodal Anion Exchange Resin. Matthew Brown

1, Sarah Johnson

1, Kurt Brorson

1, Scott Lute

1, David Roush

2,

Joseph Hughes3, Mike Burnham

3,

1US Food and Drug Administration, Silver Spring, MD,

USA; 2Merck, Kenilworth, NJ, USA;

3WuXi Apptec, Philadelphia, PA, USA

11:30 AM (L-310) Positive and Negative Mode Multi-column Processes for Enveloped Virus-

like Particles Purification. Ricardo Silva1, Alex Xenopoulos

2, Paula Alves

3, Manuel

Carrondo4, Cristina Peixoto

3,

1iBET, Oeiras, PORTUGAL;

2EMD Millipore, Bedford, MA,

USA; 3iBET/ITQB, Oeiras, PORTUGAL;

4iBET/FCT-UNL, Oeiras, PORTUGAL

11:50 AM (L-311) Purification of Cell Culture-based Influenza Virus Particles using

Membrane Filters with the Aid of Non-ionic Polymers. Pavel Marichal-Gallardo1,

Michael Martin Pieler1, Michael Wolff

2, Udo Reichl

2,

1Max Planck Institute for Dynamics of

Complex Technical Systems, Magdeburg, GERMANY; 2Max Planck Institute for

Dynamics of Complex Technical Systems and Otto von Guericke University Magdeburg, Magdeburg, GERMANY

12:10 PM (L-312) The Assembly Phase of Virus-Like Particles Contributes Significantly to

Separation and Purification. Mike Zhang, Frank Gillam, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

12:30-1:40 PM Lunch in Foyer

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PREP 2016 Final Program 21

Wednesday, July 20, 2016

13. Wednesday Session: Chromatography Fundamentals Session Chair: Jose Mota, IBET, Portugal Location: Commonwealth Hall A/B, 2nd floor

1:40 PM (L-313) Experimental and Theoretical Analysis of Chromatographic Processes in

the Presence of Liquid-liquid Phase Separation. Franziska Ortner, Marco Mazzotti, ETH Zurich, Zurich, SWITZERLAND

2:00 PM (L-314) The Loadability and Retention Behavior of Zwitterionic Stationary Phases.

Attila Felinger, University of Pecs, Pecs, HUNGARY 2:20 PM (L-315) Improving the Productivity of Capture Chromatography based on a

Simplified Mechanistic Model. Noriko Yoshimoto, Sumiko Hasegawa, Shuichi Yamamoto, Yamaguchi University, Ube, JAPAN

2:40 PM (L-316) Robust Multi-objective Optimization of Chromatographic Rare Earth

Element Separation. Hans-Kristian Knutson, Anders Holmqvist, Bernt Nilsson, Lund University, Lund, SWEDEN

3:00 PM (L-317) A Concurrent Approach for Isotherm Determination and Design of

Simulated Moving Bed Process for Multicomponent Systems. Pranav Vengsarkar, Siwei Guo, Jason Bentley, Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA

14. Wednesday Session: Advances in CPC, CCC, and Chiral Separations Session Chair: Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA Location: Commonwealth Hall A/B, 2nd floor

3:20 PM (L-318) How Can Ion-pair CPC Make Joke of RPC at Preparative Levels?

Laszlo Lorantfy1, Dora Rutterschmidt

1, Zsolt Kovacs

2, Ying Hou Guan

3, Laszlo Frici

Nemeth1,

1RotaChrom Technologiai, Dabas, HUNGARY;

2ELTE, Budapest, HUNGARY;

3BME, Budapest, HUNGARY

3:40 PM (L-319) Spiral Countercurrent Chromatography for Preparative Separations using

Aqueous Two-phase Solvent Systems. Rodrigo Lazo-Portugal1, Steingrimur

Stephansson2, Saeyoung Nate Ahn

2, Martha Knight

1,

1CC Biotech LLC, Rockville, MD,

USA; 2Fuzbien Technology Inst., Rockville, MD, USA

4:00 PM (L-320) Cost-effectiveness Modeling to Understand the Contribution of Preparative

Chiral Separations in Pharmaceutical R&D. Jeffrey Kiplinger, Paul Lefebvre, Emily Rouse, Keith Galyan, Averica Discovery, Marlborough, MA, USA

4:20 PM (L-321) Resolution of Mandelic Acid Enantiomers by Coupling Separation with

Enantioselective Chromatography and Enzymatic Racemization. Katarzyna Wrzosek, Katja Bettenbrock, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

4:40 PM CLOSING REMARKS, Giorgio Carta, University of Virginia, Charlottesville, VA, USA 4:50 PM Farewell Reception

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PREP 2016 Final Program 22

POSTER SESSION I - Monday @ 2:00 - 3:15 PM Posters in the P-100 series will be presented on Monday in Poster Session I @ 2:00 - 3:15 PM

P-M-101 Three Column Cyclic System for Protein Separation in Gradient Mode. Rafał

Gorczyca, Wojciech Marek, Roman Bochenek, Wojciech Piatkowski, Dorota Antos, Rzeszow University of Technology, Rzeszow, POLAND

P-M-102 PCR Based Cloning: A Fast, Cheap, and Easy Way to Customize Proteins at the

DNA Level. Imen Tanniche, Amanda Fisher, Ryan Senger, Mike Zhang, Frank Gillam, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

P-M-103 Flow Through Chromatography – A Powerful Purification Tool for Naked and

Enveloped Viruses. Ricardo Silva1, Alex Xenopoulos

2, Paula Alves

3, Manuel Carrondo

4,

Cristina Peixoto4,

1iBET, Oeiras, PORTUGAL;

2EMD Millipore, Bedford, MA, USA;

3iBET/ITQB, Oeiras, PORTUGAL;

4iBET/FCT-UNL, Oeiras, PORTUGAL

P-M-104 An Empirical Design Approach of Multi-column Chromatographic Processes for

Enveloped Virus-like Particles Purification. Ricardo Silva1, Alex Xenopoulos

2, Paula

Alves3, Manuel Carrondo

4, Cristina Peixoto

3,

1iBET, Oeiras, PORTUGAL;

2EMD Millipore,

Bedford, MA, USA; 3iBET/ITQB, Oeiras, PORTUGAL;

4iBET/FCT-UNL, Oeiras,

PORTUGAL P-M-105 Ceramic Hydroxyapatite for the Polish Purification of an Acidic Recombinant

Enzyme CDP-D-Glucose 4, 6-Dehydratase. Louisa Vang, Xuemei He, Bio-Rad Laboratories, Hercules, CA, USA

P-M-106 Evaluation of a Novel Adsorptive Anion Exchange Hybrid Purifier for

Biopharmaceutical Harvest Clarification and Impurity Reduction. Michael McGarrah, Hiren Ardeshna, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-M-107 In silico Modeling of Cation Exchange Chromatography Gradient Elution on Model

Systems to Develop Practical Guidelines for Step Optimization. Chris Gerberich, Andre Dumetz, Gerald Terfloth, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-M-108 Modeling of Linear pH and Salt Gradient Elution on Weak Cation Exchange Resins.

Felix Wittkopp, Christian Frech, University of Applied Sciences, Mannheim, GERMANY P-M-109 Simplifying the Purification Process for PEGylated Erythropoietin by using a

Combined Experimental/Modeling Development Approach. Roberto Falkenstein, Bernhard Spensberger, Ferdinand Stueckler, Jan Griesbach, Markus Haberger, Michaela Hook, Wolfgang Koehnlein, Ulrich Schilhabel, Ulrike Strauss, Roche Diagnostics GmbH, Penzberg, GERMANY

P-M-110 Characterizing Diatomaceous Earth and its Capacity as an Adsorbent for Proteins.

Ohnmar Khanal1, Steven Traylor

2, Nripen Singh

2, Xuankuo Xu

2, Zheng Jian Li

2, Abraham

Lenhoff1,

1University of Delaware, Newark, DE, USA;

2Bristol-Myers Squibb, Devins, MA,

USA P-M-111 Adsorption Study of Cellulose based Cation IEX Resins. Miki Iwama, Yoshihiro

Matsumoto, Yasuto Umeda, Shigeyuki Aoyama, JNC Corporation, Tokyo, JAPAN P-M-112 Novel Protein L-based Chromatography Resin for Affinity Purification of

Antibodies and Antibody Fragments. Hidetaka Kobayashi, Kosuke Araki, Shigeru Nakatani, Tosoh Corporation, Shu-nan, JAPAN

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PREP 2016 Final Program 23

POSTER SESSION I - Monday @ 2:00 - 3:15 PM Posters in the P-100 series will be presented on Monday in Poster Session I @ 2:00 - 3:15 PM

P-M-113 Optimizing Recombinant F(ab)2 Purification for Improved PET Imaging of Cancer

Biomarkers. Mark Fitchmun1, Kimberly Fitchmun

1, Ritsuko Sawada

2, Wolfgang Scholz

2,

1Somatek Inc., San Diego, CA, USA;

2MabVax Therapeutics, San Diego, CA, USA

P-M-114 Enhancing the Power of HTPD with Empirical Interpolation Models to Predict pH

and Salt Gradient Elution Behavior at High Protein Loads. Arch Creasy1, Joseph

Calzada2, Gregory Barker

2, Sibylle Herzer

2, Leland Paul

2, Giorgio Carta

1,

1University of

Virginia, Charlottesville, VA, USA; 2Bristol-Myers Squibb, Bloomsbury, NJ, USA

P-M-115 Affinity Purification of Viral Vectors. Utilizing Antibody-based Specificity in the

Manufacturing Process of Viral Vectors for Gene and Cell Therapies. Pim Hermans1,

Bruce Dawson2,

1Thermo Fisher Scientific, Leiden, THE NETHERLANDS;

2Thermo

Fisher Scientific, Wilmington, NC, USA

P-M-116 Characterizing Protein Adsorption in Polymer-Derivatized Chromatographic Media using Small-Angle Neutron Scattering. Stijn H. S. Koshari, Norman J. Wagner, Abraham M. Lenhoff, University of Delaware, Newark, DE, USA

P-M-117 Development and Implications of Single Pass TFF Prior to Capture

Chromatography. Ben Kester, Cook Pharmica, Bloomington, IN, USA P-M-118 Multi-Column Continuous Chromatography for Protein A Capture and Orthogonal

Polishing of Monoclonal Antibodies. Anthony Grabski, Tom Van Oosbree, Beth Hammer, Robert Mierendorf, Semba Biosciences, Inc., Madison, WI, USA

P-M-119 EcoPrime Twin – Continuous Two-Column Chromatography at the Process Scale.

Kathleen Mihlbachler, LEWA Process Technologies, Devens, MA, USA

P-M-120 Purification of Secretory Immunoglobulins by Chromatographic Methods. Hannah

Engelmaier, Alexander Matlschweiger, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA

P-M-121 High Pressure Homogenization: Impact of Operating Conditions on Further

Downstream Processing. Christopher Zartler, Bernhard Sissolak, Rainer Hahn, BOKU Vienna, Vienna, AUSTRIA

P-M-122 PuroPhase SPE Reverse Phase - A New Complete Platform for SPE. Christopher

Bresner1, Ksenia Sochilina

2, Alessandra Basso

1,

1Purolite, Llantrisant, UK;

2Purolite,

Moscow, RUSSIA

P-M-123 Experimental Validation of Relay Simulated Moving-bed Chromatography. Jose Mota

1, Ricardo Silva

2,

1LAQV/REQUIMTE & IBET, Caparica, PORTUGAL;

2IBET,

Oeiras, PORTUGAL P-M-124 Application of Spiral Countercurrent Chromatography to Natural Product

Separation. Cuiping Chen1, William Folk

2, Thomas Finn

1, Martha Knight

1,

1CC Biotech

LLC, Rockville, MD, USA; 2University of Missouri, Rolla, MO, USA

P-M-125 Extractive Sample Introduction in Preparative Supercritical Fluid Chromatography.

Geoffrey Cox1, Mohamed Shaimi

2,

1PIC Solution Inc., Media, PA, USA;

2PIC Solution

SAS, Avignon, FRANCE

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PREP 2016 Final Program 24

POSTER SESSION I - Monday @ 2:00 - 3:15 PM Posters in the P-100 series will be presented on Monday in Poster Session I @ 2:00 - 3:15 PM

P-M-126 Robust Multi-objective Optimization of Chromatographic Rare Earth Element

Separation. Hans-Kristian Knutson, Anders Holmqvist, Bernt Nilsson, Lund University, Lund, SWEDEN

P-M-127 Harmonizing a Workflow in a Variable Chemical Space to Enable High Throughput

Purification. Greg Ciszewski, Justin Bellenger, Khunte Bhagyashree, Patrick Mullins, Pfizer, Groton, CT, USA

P-M-128 Dual Flow Chromatography for Automated Process Development. Carrie Huynh,

Douglas Gjerde, PhyNexus, San Jose, CA, USA P-M-129 Generalized Perturbation Method to Determine Multicomponent Isotherm for

Saturated Systems. Siwei Guo, Pranav Vengsarkar, Jason Bentley, Yoshiaki Kawajiri, Georgia Institute of Technology, Atlanta, GA, USA

P-M-130 A Preparative Liquid Chromatograph Equipped with On-Line Fraction Trapping and

On-Column Washing Technology Realizes Recovering of Target Compounds with High Purity in Short Time. Tomoyuki Yamazaki

1, Tsutomu Okoba

1, Saki Yoshino

1, Ei-

ichi Matsuo1, Yoshihiro Hayakawa

1, Yosuke Iwata

1, Robert Buco

2, Masayuki Nishimura

3,

1Shimadzu Corporation, Kyoto, JAPAN;

2Shimadzu Corporation, Marlborough, MA, USA;

3Shimadzu Corporation, Columbia, MD, USA

P-M-131 Purification of Biopharmaceutical Proteins and Peptides using Ion-Exchange Bulk

Media Designed for High Throughput Purification. Noriko Shoji1, Chie Yokoyama

1,

Chiaki Iwata1, Munehiro Shoda

1, Takashi Sato

1, Takatomo Takai

1, Ernest J. Sobkow

2,

1YMC Co., Ltd., Kyoto, JAPAN;

2YMC America, Allentown, PA, USA

P-M-132 SAM-C18 Bulk Packing as Alternative for Large Scale Reversed-Phase Purification.

Hafeez D. Fatunmbi, Separation Methods Technologies, Newark, DE, USA P-M-133 Model-based Conversion of a Single-column Batch Process to 3- and 4-Column

Periodic Counter-current Chromatography. Tobias Hahn, Thiemo Huuk, Fabian Gorlich, Gang Wang, Jurgen Hubbuch, KIT, Karlsruhe, GERMANY

P-M-134 Separation of Astaxanthin from the Crude Extract of Haematococcus Pluvialis by

Simulated Moving Bed. Xiao-Qing Bao, Wen-Tung Wu, Chih-Hsiung Lin, Ya-Ting Shih, Ming-Tsai Liang, I-Shou University, Kaohsiung, TAIWAN

P-M-135 Development and Evaluation of an Enhanced Resin Sanitization Procedure using

Microbial Kill and Resin Lifetime Studies. Zhi Li, Thomas Gervais, Bristol-Myers Squibb, East Syracuse, NY, USA

P-M-136 Biophysical Investigation Into Host-Cell Protein – Monoclonal Antibody

Associations. Swarnim Ranjan1, Wai Keen Chung

2, Min Zhu

2, David Robbins

2, Steven

Cramer1,

1RPI, Troy, NY, USA;

2MedImmune, Gaithersburg, MD, USA

P-M-136

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PREP 2016 Final Program 25

POSTER SESSION II - Tuesday @ 2:00 - 3:15 PM Posters in the P-200 series will be presented on Tuesday in Poster Session II @ 2:00 - 3:15 PM

P-T-201 Determination of Scale-down Criteria and Evaluation of Different Pumping Modes

to Mimic Commercial Scale Viral Filter Performance. Prasad Pathange, Bayer HealthCare, Berkeley, CA, USA

P-T-202 Process Design Strategy to Monitor and Improve Purification of Influenza Virus-

like Particles using Click Chemistry. Sofia Carvalho1, Ricardo Silva

3, Joao Freire

2,

Mafalda Moleirinho3, Francisca Monteiro

1, Diana Gaspar

2, Miguel Castanho

2, Paula

Alves1, Gonçalo Bernardes

4, Cristina Peixoto

1, Manuel Carrondo

5,

1IBET/ITQB-UNL,

Oeiras, PORTUGAL; 2IMM, Lisboa, PORTUGAL;

3IBET, Oeiras, PORTUGAL;

4IMM/University of Cambridge, Lisboa/Cambridge, Portugal/UK;

5IBET/ITQB-UNL/FCT-

UNL, Oeiras/Caparica, PORTUGAL P-T-203 Downstream Processing of Influenza Virus-like Particles using an All-filtration

Technology Platform. Sofia Carvalho1, Ricardo Silva

2, Barbara Cunha

1, Mafalda

Moleirinho2, Alex Xenopoulos

3, Paula Alves

1, Cristina Peixoto

1, Manuel Carrondo

4,

1IBET/ITQB-UNL, Oeiras, PORTUGAL;

2IBET, Oeiras, PORTUGAL;

3EMD Millipore,

Boston, MA, USA; 4IBET/ITQB-UNL/FCT-UNL, Oeiras/Caparica, PORTUGAL

P-T-204 Positive and Negative Mode Multi-column Processes for Enveloped Virus-like

Particles Purification. Ricardo Silva1, Alex Xenopoulos

2, Paula Alves

3, Manuel

Carrondo4, Cristina Peixoto

3,

1iBET, Oeiras, PORTUGAL;

2EMD Millipore, Bedford, MA,

USA; 3iBET/ITQB, Oeiras, PORTUGAL;

4iBET/FCT-UNL, Oeiras, PORTUGAL

P-T-205 Development of a Two-step, cGMP-compliant Process for Adenovirus Purification.

Mark Fitchmun1, John Chicca

2, Mark Snyder

3,

1Somatek, San Diego, CA, USA;

2Molecular Diagnostic Systems, San Diego, CA, USA;

3Bio-Rad Laboratories, Hercules,

CA, USA P-T-206 Continuous Purification Platforms for Viral Vectors based on Multicolumn

Simulated Countercurrent Chromatography. Jose Mota1, Ricardo Silva

2, Cristina

Peixoto2, Manuel Carrondo

2,

1LAQV/REQUIMTE and IBET, Caparica, PORTUGAL;

2IBET, Oeiras, PORTUGAL

P-T-207 Experimental Realization of Single-column Batch Chromatography with Recycle

Lag. Abimaelle Chiberio, Snezana Reljic, Rui Ribeiro, Jose Mota, LAQV/REQUIMTE, Caparica, PORTUGAL

P-T-208 Evaluation of Loading Characteristics and IgG Binding Performance of

Staphylococcal Protein A on Polypropylene Capillary-channeled Polymer Fibers. Hung Trang

1, Abby Schadock-Hewitt

2, Liuwei Jiang

1, R. Kenneth Marcus

1,

1Clemson

University, Clemson, SC, USA; 2Bristol-Myers Squibb, Devens, MA, USA

P-T-209 Statistical Evaluation of Performance Parameters of Pre-packed Columns over a

Time Span of Ten Years. Tim Schroeder1, Theresa Scharl Hirsch

2, Christian

Jungreuthmayer2, Astrid Durauer

3, Alois Jungbauer

3,

1Atoll GmbH, Weingarten,

GERMANY; 2Austrian Centre of Industrial Biotechnology, Vienna, AUSTRIA;

3University

of Natural Resources and Life Sciences, Vienna, AUSTRIA P-T-210 Modeling of Anion-Exchange Chromatography: Influence of Ligand Densities on

Protein Separation. Felix Wittkopp1, Lars Peeck

2, Heiner Graalfs

2, Christian Frech

1,

1Hochschule Mannheim University of Applied Sciences, Mannheim, GERMANY;

2Merck

KGaA, Darmstadt, GERMANY P-T-211 A Comparison of Ordered Internal Column Morphologies Manufactured using 3D

Printing. Suhas Nawada1, Conan Fee

1, Simone Dimartino

2,

1University of Canterbury,

Christchurch, NEW ZEALAND; 2The University of Edinburgh, Edinburgh, UK

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PREP 2016 Final Program 26

POSTER SESSION II - Tuesday @ 2:00 - 3:15 PM Posters in the P-200 series will be presented on Tuesday in Poster Session II @ 2:00 - 3:15 PM

P-T-212 In-Silico Process Development: Success Stories. Teresa Beck

1, Thiemo Huuk

1,

Tobias Hahn1, Juergen Hubbuch

2,

1GoSilico, Karlsruhe, GERMANY;

2Karlsruhe Institute

of Technology, Karlsruhe, GERMANY P-T-213 Efficient Separation of Antibodies based on Their Glycan Structures with Affinity

Resin Coupling Engineered Fc Receptor. Yosuke Terao, Toru Tanaka, Naoki Yamanaka, Yoshiharu Asaoka, Masaru Aoki, Shizuka Nishiyama, Seigo Oe, Teruhiko Ide, TOSOH Corporation, Ayase, JAPAN

P-T-214 A Mechanistic Investigation into Chromatography Resin Aging: Scalable and Non-

Scalable Effects on Ionic Capacity. Andrew Pike, Phillip Smith, Bruno Marques, Kent Goklen, GlaxoSmithKline, King of Prussia, PA, USA

P-T-215 Development of Chromatography Media for High-throughput Purification Process

of Monoclonal Antibody. Yoshito Fukuda, Shoya Yoda, Kazuhiko Tokunaga, Shinya Nozaki, Noriyuki Yasuda, Shouhei Ohara, Masato Towata, Tadashi Adachi, Mitsubishi Chemical, Kitakyushu, JAPAN

P-T-216 Application of QbD for Late Stage Downstream Process Development of a

Monoclonal Antibody based Fusion Protein. George Enriquez, Ying Yang, Judy Miao, Iraj Ghazi, Shire, Lexington, MA, USA

P-T-217 Dedicated Protein A Resins for Clinical Manufacturing, Regular Production, or

Purification of Acid Sensitive MAbs. Hans J. Johansson, Purolite, Llantrisant, UK P-T-218 Accelerated Evolution: Advancing Antibody Affinity Technology to Meet the Needs

of Next Generation Antibody Processes. Jonathan Royce, Mats Gruvegard, Mats Ander, Tomas Bjorkman, Elin Monie, Gustav Rodrigo, Ronnie Palmgren, GE Healthcare, Uppsala, SWEDEN

P-T-219 Optimization of Productivity, Efficiency and Buffer use for Continuous

Countercurrent Tangential Chromatography (CCTC) Platform. Oleg Shinkazh, ChromaTan, State College, PA, USA

P-T-220 Adsorption and Separation of Native and PEGylated Proteins on Anion Exchange

Resins with Varying Length of Polymer Grafting. Mimi Zhu, Preston Fuks, Giorgio Carta, University of Virginia, Charlottesville, VA, USA

P-T-221 Prepacked Chromatography Columns: Evaluation for use in Pilot and Large-Scale

Bioprocessing. Shaun Grier, Saani Yakubu, Shire Pharmaceuticals, Lexington, MA, USA

P-T-222 Influenza Virus Capture using Membrane Chromatography: Improving Selectivity

by Matrix Design and Pseudo-Affinity Ligand Interactions. Florian Taft1, Sebastian

van Teeffelen2, Ana Raquel Fortuna

2, Michael Wolff

2, Udo Reichl

2, Louis Villain

1,

1Sartorius Stedim Biotech GmbH, Goettingen, GERMANY;

2Max Planck Institute for

Dynamics of Complex Technical Systems, Goettingen, GERMANY P-T-223 Thermodynamic Analysis of Multiple Components Resolution in Chromatography

at Various Temperatures. Gorgi Pavlov, James T. Hsu, Lehigh University, Bethlehem, PA, USA

P-T-224 High Throughput and High Purity Purification with Displacement Chromatography.

Ming Zeng, Pfizer Inc, Groton, CT, USA

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PREP 2016 Final Program 27

POSTER SESSION II - Tuesday @ 2:00 - 3:15 PM Posters in the P-200 series will be presented on Tuesday in Poster Session II @ 2:00 - 3:15 PM

P-T-225 Screening Approach for the Separation of Pharmaceutical Compounds using Lux®

Polysaccharide-Based Chiral Stationary Phases in SFC Mode. Marc Jacob, Simon Lomas, Phenomenex, Torrance, CA, USA

P-T-226 Development of a Multi-Step Synthetic Peptide Purification Process Utilizing a

Single Stationary Phase. J. Preston1, Marc Jacob

1, Guido Krautz

2,

1Phenomenex,

Torrance, CA, USA; 2Phenomenex, Aschaffenburg, GERMANY

P-T-227 An Operation of the Advanced Simulated Moving Bed Chromatography (A-SMB)

with Reduced Solvent Consumption. Kazuo Okada, Kohei Sato, Masaki Tsuruta, Organo Corporation, Sagamihara, JAPAN

P-T-228 Robust and Efficient Purification of Enantiomers using Novel Polysaccharides

Type Chiral Stationary Phases. Saoko Nozawa1, Mai Sato

1, Akiko Matsui

1, Takashi

Sato1, Tom Seno

1, Noritaka Kuroda

1, Ernest J. Sobkow

2,

1YMC Co., Ltd., Kyoto, JAPAN;

2YMC America, Allentown, PA, USA

P-T-229 A Comparison of Preparative HPLC, Closed-loop Recycling, and Simulated Moving

Bed for Cost-effective Separation of Enantiomers. Saoko Nozawa1, Mai Sato

1, Akiko

Matsui1, Takashi Sato

1, Tom Seno

1, Noritaka Kuroda

1, Ernest J. Sobkow

2,

1YMC Co.,

Ltd., Kyoto, JAPAN; 2YMC America, Allentown, PA, USA

P-T-230 Enzymatic Racemization to Recycle of Undesired Enantiomer in Chiral Separation.

Katarzyna Wrzosek, Thiane Carneiro, Katja Bettenbrock, Andreas Seidel-Morgenstern, Max Planck Institute for Dynamics of Complex Technical Systems, Magdeburg, GERMANY

P-T-231 Isolation and Analysis of Cannabinoids from Hemp and Cannabis Extracts using SFC. Martin Enmark

1, Kurt Levy

2, Brian Reid

2,

1Horizonoid Ltd., Evergreen, CO, USA;

2Ebbu LLC, Evergreen, CO, USA

P-T-232 Little Science – Big Difference in Peptide Purification Processes. Oscar Rebolledo

1,

Imre Sallay2, Keiji Koyanagi

2,

1DAISO Fine Chem USA, Inc., Torrance, CA, USA;

2Osaka

Soda Co., Ltd., Osaka, JAPAN P-T-233 Re-Evaluation of the CIP Step in Insulin-Related RP HPLC Processes. Imre Sallay

1,

Oscar Rebolledo2, Keiji Koyanagi

1,

1Osaka Soda Co. Ltd., Osaka, JAPAN;

2DAISO Fine

Chem USA, Inc., Torrance, CA, USA P-T-234 Purification and Conversion of Bio-mevalonate into Mevalonolactone.

Pyung Cheon Lee, Bun Yeol Lee, Jin Won Kim, Hee Chan Yoon, Ajou University, Suwon, SOUTH KOREA

P-T-235 Mechanistic Modeling for Enhanced Quality Control Flexibility. Torgny Fornstedt

1,

Dennis Åsberg1, Jörgen Samuelsson

1, Anders Karlsson

2,

1Karlstad University, Karlstad,

SWEDEN; 2AstraZeneca R&D, Gothenburg, SWEDEN

P-T-236 Novel Through-porous Particles Applied to Chromatography. Norio Ishizuka

1,

Ryosuke Takahashi2, Hiroki Kanezaki

2, Moemi Miyashita

2, Ken Tsutsui

2, Masahide

Kobayashi2, Takashi Yukiyama

2, Noritaka Kuroda

2, Naohiro Kuriyama

2,

1Emaus Kyoto

Inc., Kyoto, JAPAN; 2YMC Co., Ltd., Kyoto, JAPAN

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PREP 2016 Final Program 28

Leading Companies at the Forefront of Preparative and Process Chromatography

AGILENT TECHNOLOGIES 2850 Centerville Road, Wilmington, DE 19808, USA 800-227-9770 www.agilent.com Agilent is committed to providing advanced laboratory solutions that help scientists solve real-world problems such as ensuring the quality of food, water, and air; managing the world’s resources and energy; and developing therapeutics and diagnostics to fight disease. AKZONOBEL/KROMASIL 281 Fields Lane, Brewster, NY 10509, USA 914-482-7798 www.kromasil.com AkzoNobel offers Kromasil®, high performance chromatographic media based on state-of-the-art spherical silica for UHPLC, HPLC and SFC analysis as well as small scale purification plus bulk material for HPLC, SFC and SMB process technology. Kromasil materials’ unique combination of pore volume and surface area, together with its very high mechanical and chemical stability is unmatched for the separation of a wide variety of substances from small molecules to peptides and proteins. Kromasil is available for an extensive range of NP, RP, SCF and chiral applications providing solutions to the pharmaceutical, natural products, food and beverage, industrial and clinical markets for over a quarter of a century. AVANTOR™ PERFORMANCE MATERIALS 3477 Corporate Parkway, Center Valley, PA 18034, USA 610-573-2600 www.AvantorMaterials.com Avantor™ Performance Materials manufactures and markets high-performance chemistries and materials—including our proven line of J.T.Baker® BAKERBOND™ Process Chromatography Media. Avantor offers the expert collaboration, data transparency and proven quality systems needed to help our global customers advance biopharmaceuticals and biotechnology. Learn more about our robust product portfolio for life sciences by visiting www.avantormaterials.com. BIO-RAD LABORATORIES, INC. 2000 Alfred Nobel Drive, Hercules, CA 94547, USA 800-424-6723 www.bio-rad.com/process Bio-Rad Laboratories is a leading provider to the life science and clinical diagnostics markets where the company’s products are used for scientific discovery, drug development, and biopharmaceutical production. Bio-Rad’s long-lasting customer relationships foster the company's research and development efforts and inspire the introduction of innovative products and solutions that accelerate the discovery process and improve healthcare. The Protein Purification Business, part of the Life Science Group at Bio-Rad, provides researchers with the chromatography tools they need to isolate and purify proteins from laboratory scale into bioprocess manufacturing. With more than 50 years of purification experience, Bio-Rad continues to expand solutions to support each phase of the biotherapeutics purification process.

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PREP 2016 Final Program 29

Leading Companies at the Forefront of Preparative and Process Chromatography

CC BIOTECH LLC 12111 Parklawn Drive, Rockville, MD 20852, USA 240-669-9281 www.ccbiotech.us Novel separations technology available with 2 instruments from CC Biotech, Rockville MD. Coming out is a prep-scale spiral countercurrent chromatograph that can do separations of extracts, peptides, proteins and now, recently reported, carbon nanotubes. Various types of spiral-design rotors will be displayed. Many new analysis methods for life and materials science are possible. The Rotify®, a centrifugal precipitation chromatograph that purifies proteins by precipitation point in a versatile gradient, is shown.

DAISO FINE CHEM USA INC. / DAISOGEL 3858 W Carson Street, Suite 126, Torrance, CA 90503, USA 310-540-5312 www.daisogelusa.com DAISOGEL® is manufactured in our ISO9001 certified facility and bonded in our GMP-compliant facility in Amagasaki, Japan. DAISOGEL® is available in C18, C8, C4 and more bonded phases in wide variety particle sizes from 1.7 micron up to 50 micron. We offer pre-packed columns and bulk silica up to 200kg batches for large-scale production, offering high batch-to-batch reproducibility, excellent particle size distribution, consistent selectivity and high productivity, facilitating scale up and production. ESSENTIAL LIFE SOLUTIONS – EMP BIOTECH 308 Tosca Drive, Stoughton, MA 02072, USA 781-341-7240 www.essential-life.net Essential Life Solutions (Tel 781-341-7240) and emp Biotech (Tel 732-547-7421) are proud to offer a complete package of innovative high quality HPLC/TPLC chromatography columns and matrices. Along with a wide variety of glass and acrylic columns ranging from 5 mm diameters to 2 meters from Essential Life Solutions and a variety of high quality resins from emp Biotech, packed columns are an additional option. Please stop by booth 302 to discuss your requirements. ITOCHU CHEMICALS AMERICA 360 Hamilton Avenue, 6

th Floor, White Plains, NY 10601, USA

914-333-7800 www.itochu-purification.com/ Itochu Chemicals America's Separation and Purification group is the exclusive representative for ion exchange resins from Mitsubishi Chemical (Diaion, Sepabeads, MCIGEL, and Relite) and Zeochem chromatography silica (ZEOprep, ZEObead, and ZEOsphere). Mitsubishi Chemical has launched a new line of resins for protein and antibody purification called ChromSpeed (ion exchange) and MabSpeed (Protein A). Zeochem recently launched their ZEOsphere Doped Reverse Phase (DRP) mixed mode reverse phase silica for peptide, oligo, and other charged molecule purifications.

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Leading Companies at the Forefront of Preparative and Process Chromatography

JASCO 28600 Mary’s Court, Easton, MD 21601, USA 800-333-5272 www.jascoinc.com JASCO specializes in analytical instruments for chromatography and spectroscopy applications, with over 55 years of experience. JASCO’s worldwide presence, superior product quality and outstanding service and support make the company an industry leader. JASCO offers a complete line of modular chromatography systems including SFC/SFE, HPLC, RHPLC and UHPLC (analytical, semi-prep, & preparative). JASCO is also recognized for its robust and reliable line of spectroscopy products including FTIR, single point and imaging FTIR microscopes, Field-Rugged FTIR, UV-Vis/NIR, Fluorescence, Confocal Imaging Raman Microscopes, Field-Rugged Raman Probes, Polarimeters, Circular Dichroism and Dissolution.

JNC AMERICA 555 Theodore Fremd Avenue, Suite C-206, Rye, NY 10580, USA 914-921-5400 www.jncamerica.com We at JNC Group, “a leading chemical company that aims to contribute to society’s progress through superior technology,” have created progressive products and technologies ever since our founding in 1906 to keep pace with the advancement of society. Our mission is to contribute to a comfortable living, sustainable industry as well as to create products and technologies in harmony with the Earth’s environment. JSR LIFE SCIENCES 1280 N. Mathilda Avenue, Sunnyvale, CA 94089, USA 408-543-8800 www.jsrlifesciences.com JSR Life Sciences provides specialized materials and products to the biotech industry. With its US operations in Sunnyvale, CA, JSR Life Sciences operates a network of manufacturing facilities, sales offices and R&D labs in key markets throughout North America, Europe and Asia-Pacific. JSR Life Sciences is focused on downstream bioprocessing materials for pharmaceutical manufacturing and diagnostics and research reagents. JSR Life Sciences manufactures and markets Amsphere™ A3, a protein A chromatography resin for downstream processing. KANEKA AMERICAS HOLDING 546 Fifth Avenue, 21

st Floor, New York, NY 10036, USA

212-705-4340 www.kaneka.com Kaneka is a worldwide leader, and provider, of Affinity resin technology to the Life Sciences Industry. KANEKA KanCapA™ is a highly efficient protein A affinity chromatography resin designed to improve your monoclonal Antibody (mAb) purification platform. KANEKA KanCapA™ affinity resin is based on a unique combination of a proprietary recombinant alkaline stable Protein A ligand and an innovative highly cross-linked cellulose base matrix. KANEKA KanCapA™ is designed for the industrial–scale purification of monoclonal antibodies.

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PREP 2016 Final Program 31

Leading Companies at the Forefront of Preparative and Process Chromatography

LCGC 485F US Highway 1 South, Suite no. 210, Iselin, NJ 08830, USA 732-596-0276 www.chromatographyonline.com For more than 33 years, LCGC has been the gold standard relied upon by chromatographers for unbiased, nuts-and-bolts technical information with a practical focus. LCGC’s columns and peer-reviewed articles continue to bring readers practical technical advice from respected experts in liquid and gas chromatography, including hyphenated techniques; capillary electrophoresis; supercritical fluid chromatography; and more. NOVASEP 23 Creek Circle, Boothwyn, PA 19061, USA 610-494-0447 www.novasep.com Novasep is a leading worldwide provider of integrated manufacturing solutions for the Life Science industries. We master a unique range of chromatographic technologies (HPLC, SFC, LPLC, continuous chromatography) for the purification of both synthetic and bio-molecules. With its unique business model, Novasep provides solutions to support strategic decision to either insource or outsource the production of our customer’s target molecules. Our offering includes process development, chromatography units (columns, pumping skids), and contract manufacturing. PIC SOLUTION INC. PO Box 191, Media, PA 19065, USA 484-319-4281 www.pic-sfc.com PIC Solution develops and manufactures analytical and preparative scale supercritical fluid chromatographs (SFC) and extraction (SFE) systems. Preparative chromatography equipment ranges from the bench-top SFC-PICLab PREP 100 to the pilot scale SFC-PICLab PREP 1000, a range mirrored by the SFE equipment. The SFC-PICLab Analytic, an analytical SFC designed with automated method development capability in mind and the SFC-PICLab Hybrid which combines analytical and preparative scale systems into a single instrument are also available. PUROLITE LIFE SCIENCES 150 Monument Road, Bala Cynwyd, PA 19004, USA 800-343-1500 (US) or 44-778-531-8440 (UK) www.purolite.com Purolite has over 35 years’ experience providing resin solutions, with dedicated R&D and manufacturing facilities worldwide. Purolite Life Sciences provides APIs and blood purification polymers, Lifetech™ resins for enzyme immobilization, ready to use immobilized enzymes and Chromalite® synthetic chromatographic resins. Our new PuroPhase™ SPE solid phase extraction product line is ideal for clean-up and extraction of polar and non-polar analytes. Praesto® agarose-based media are designed for MAb and recombinant protein purification. which now includes Praesto APc - a new clinical, alkaline-tolerant, modified Protein-A.

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PREP 2016 Final Program 32

Leading Companies at the Forefront of Preparative and Process Chromatography

QUANTUM ANALYTICS 3400 East 3rd Avenue, Foster City, CA 94404, USA 650-312-0900 www.LQA.com Quantum Analytics Value-added distributor of multi-vendor analytical instruments - including Chromatography & Mass Spectrometry systems from Agilent Technologies and Mass Detection Systems from Microsaic. We offer an array of customized instrument financing solutions, technical services, cross-platform system integration, installation, training and product support. SEMBA BIOSCIENCES, INC. 601 Science Dr, Madison, WI 53711, USA 866-634-1114 www.sembabio.com Semba Biosciences pioneered the development of bench top SMB continuous chromatography systems. Our Octave™ product line has become the gold standard for versatility and reliability in lab-scale continuous chromatography. Now we are introducing some exciting new innovations in multicolumn continuous chromatography for bioprocess development and single-use GMP manufacturing. Get inspired and visit our booth. SEPARATION METHODS TECHNOLOGIES, INC. (SMT) 31 Blue Hen Drive, Newark, DE 19713, USA 302-368-0610 https://separationmethods.com Separation Methods Technologies, Incorporated (SMT) is a surface chemistry research and manufacturing corporation founded in 1993. SMT's goal is to provide chromatographers with outstanding specialty columns and bulk packing materials for various separation chemistries, ranging from analytical to the process scale. The primary focus for SMT is on the creation of well-organized functional molecules on substrate surfaces for various functions, including chromatographic applications and materials engineering. SP SCIENTIFIC – GENEVAC 3538 Main Street, Stone Ridge, NY 12484, USA 845-687-0071 www.spscientific.com/genevac World leaders in Centrifugal Evaporator technology, Genevac's high performance systems are designed for use in chemistry, biology and analytical science applications. Whether concentrating a few microliters or removing 100 litres, Genevac’s patented evaporation systems can handle even the most difficult solvents and mixtures without compromising sample purity or integrity. Genevac is part of SP Scientific, a leading manufacturer of specialty equipment for science and industry.

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PREP 2016 Final Program 33

Leading Companies at the Forefront of Preparative and Process Chromatography

THERMO FISHER SCIENTIFIC 7305 Executive Way, Frederick, MD 21704, USA 800-678-5599 www.thermofisher.com Thermo Fisher Scientific supplies innovative solutions for the world's pharmaceutical and biopharmaceutical industries. With applications that span the drug development process – from drug discovery through large-scale commercial production - we provide a broad range of products and services for cell culture, purification and analytics. POROS® and CaptureSelect™ chromatography resins offer high performance polish and unprecedented affinity chromatography solutions. YMC AMERICA, INC. 941 Marcon Blvd., Suite 201, Allentown, PA 18109, USA 610-266-8650 www.ymcamerica.com YMC America, Inc is engaged in technical support, sales, and distribution of YMC brand products from its main offices and laboratory in Allentown, PA, USA, and its preparative chromatography support and demonstration facility located in San Diego, CA, USA. YMC products include Triart hybrid, HG Series and Chiral Art (coated and immobilized) stationary phases, BioPro CEX and SAX resins and preparative lab, pilot and production K-Prep HPLC Systems and DAC and Glass columns. YPSO-FACTO 10 viaduc Kennedy, 54000 Nancy, FRANCE 33-355 961 656 www.ypsofacto.com YPSO-FACTO, Your Process Secured and Optimized. Ypso-Facto is a service company helping industrial firms to develop, optimize and secure their chemical and biochemical processes. We gather experts from the industrial and academic worlds, with complementary competences in chemistry, biochemistry and process engineering. Our independent services include: - Software to model, simulate and design processes; - Consulting for scientific and technical support; - Laboratory services. We have developed a chromatographic process simulation software, ChromWorks

TM, featuring most

commercial chromatographic processes.

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