CE in the Biotechnology & Pharmaceutical Industries: 19 th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules (CE Pharm 2017) Symposium Co-Chairs: Steffen Kiessig, F. Hoffmann – La Roche Ltd. David Michels, Genentech, a Member of the Roche Group September 17-20, 2017 Boston Park Plaza Hotel Boston, MA Organized by
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CE in the Biotechnology &
Pharmaceutical Industries:
19th Symposium on the Practical
Applications for the Analysis of
Proteins, Nucleotides and Small
Molecules
(CE Pharm 2017)
Symposium Co-Chairs:
Steffen Kiessig, F. Hoffmann – La Roche Ltd.
David Michels, Genentech, a Member of the Roche Group
September 17-20, 2017
Boston Park Plaza Hotel
Boston, MA
Organized by
2
Table of Contents
Welcome Letter .......................................................................................................... 3
CE Pharm Award ....................................................................................................... 4
Table 7 What Are the Most Challenging Separation/Identification Problems Now
(e.g. Subvisible Particles) and How Does CE Fit In?
Facilitator: Joshua Woods, Pfizer, Inc.
Scribe: Yunan Wang, Amgen Inc.
Table 8 Trends in Pharmaceutical Application of CE
Facilitator: Maria Schwarz, Solvias AG
Scribe: Nathan Lacher, Pfizer, Inc.
Table 9 Hot Topic (TBD)
Facilitator: David Michels, Genentech, a Member of the Roche Group
Scribe: Tim Blanc, Eli Lilly & Company
Table 10 Hot Topic (TBD)
Facilitator: Steffen Kiessig, F. Hoffmann - La Roche Ltd.
Scribe: Joel Welch, CDER, FDA
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Technical Seminars Technical Seminar: Lunch and Learn
Monday, September 18
12:00 – 13:00
Georgian Ballroom
Fast Glycan Labeling & Analysis: Sensitive CE-LIF Detection with Automated Glycan
Identification
András Guttman
SCIEX, Brea, CA USA, University of Debrecen, Debrecen, Hungary
A Fast Glycan Labeling & Analysis technology has been developed for N-linked oligosaccharide
profiling of glycoproteins along with a gel-buffer system to ensure rapid and high-resolution
separation of the target molecules. Glycan release, fluorophore labeling and clean-up parameters
were all optimized resulting in 60 min sample preparation time using a novel magnetic bead
mediated protocol that assures excellent yield, high reproducibility and easy automation.
Optimization included rapid endoglycosidase digestion and fluorophore labeling time and
temperature as well as sample clean-up, supporting fast sample processing. The procedure does
not require any centrifugation and vacuum centrifugation steps, otherwise necessary for most
glycan sample preparation methods. Capillary electrophoresis analysis with laser induced
fluorescence detection (CE-LIF) of the fluorophore (APTS) labeled glycans was also optimized
to enable rapid and high-resolution separations of the labeled sugars just within a few minutes, in
order to accommodate both manual and automated sample processing. We also report on the
design and implementation of a co-injection based triple-internal standard mediated
glycoinformatics method, to alleviate the need of an accompanying run of the
maltooligosaccharide ladder for precise glucose unit (GU) calculation based structural
assignment. The importance of precise temperature control during CE-LIF analysis is also
emphasized. Worked examples will show comprehensive glycan composition analysis of some
of the most prescribed monoclonal antibody therapeutics and their biosimilar counterparts.
Quantitative assessment and automatic structural identification of glycans of CQA importance in
biologics development will also be discussed.
NOTES:
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Technical Seminar: Lunch and Learn
Tuesday, September 19
11:45 – 12:45
Georgian Ballroom
Maurice, The Workhorse CE System for your Biologics
XiaoPing He1, Chris Heger2
1Pfizer, Inc., Chesterfield, MO USA, 2 ProteinSimple, a Bio-Techne brand, San Jose, CA USA
Years ago, iCE revolutionized how cIEF is used in Biologics development processes with the
introduction of imaged cIEF.
Now, Maurice further streamlines and extends the use of capillary electrophoresis to simplify
your protein profiling. On Maurice, we’ve augmented our icIEF technology with sensitive native
fluorescence detection capabilities and now offer in addition seamless switching to the newly
added CE-SDS mode to bring a lot more “iCE” to your biologics analysis.
At this technical seminar, you will be hearing about the evaluation of Maurice at Pfizer and
Fujifilm. XiaoPing He, M.Sc. (Senior Scientist, Pfizer) will discuss her experience with Maurice
in Size and cIEF mode during her validation of the platform. Chris Heger Ph.D., Manager,
Applications Science at ProteinSimple San Jose will discuss aspects of CE-SDS method
development on Maurice using real world examples from a collaboration with FujiFilm and give
an introduction on combining Maurice and our Simple Western technology in your bioprocess
workflow.
The seminar will be interactive to encourage discussion with speakers, the ProteinSimple team,
and to share your own experiences.
NOTES:
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Technical Seminar
Tuesday, September 19
15:15-16:15
Georgian Ballroom
A Tale of Three Transfers: The Good, the Bad, and the Ugly - Transfer of mAb Purity
Analysis to cGMP Organizations
Niomi Peckham
Alexion Pharmaceuticals, New Haven, CT USA
Alexion’s focus on rare diseases often translates into accelerated development timelines, making
high throughput and flexible platforms a necessity. Protein analysis on the Caliper LabChip has
been adopted by Alexion for monoclonal antibodies from Pre-Clinical through Validated Phase
II/III release and stability applications. Contract manufacturing organizations (CMOs) have also
been utilized for manufacturing and analytical support to progress several clinical stage
molecules, resulting in repeated transfers of the LabChip assays to cGMP laboratories. Here, we
describe transfer of validated assays to three cGMP labs concurrently.
NOTES:
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NOTES:
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List of Posters
Analysis of Product and
Process Related Impurities Using CE
P-101
Non-Glycosylated Heavy Chain Analysis Crossover: Agilent Bioanalyzer 2100 to
PerkinElmer LabChip® GXII
Troy Adams, Jigna Patel, Mike Smith, Byron Dipaolo, Jennifer Dally
GlaxoSmithKline, King of Prussia, PA USA
P-102
Development of CE-SDS Method using Maurice for the Purity of Adeno-associated Virus
(AAV) Capsids
Wei-Chiang Chen
Biogen, Cambridge, MA USA
P-103
Comparison Between Maurice and iCE
K. Steven Cook, Xiaoping He
Pfizer, Inc., Chesterfield, MO USA
P-104
A High Throughput Sample Preparation and Analytical Method for N-Glycan Analysis on
Multi-capillary CE and UHPLC
Anahita Eckard, Johnie K. Young, Baburaj Kunnummal, Peter Bell
Thermo Fisher Scientific, South San Francisco, CA USA
P-105
A Method for Rapid and Complete Release of N-Glycans from Simple and Complex
Glycoproteins
Anahita Eckard, David Dupont, Johnie K. Young, Baburaj Kunnummal, Peter Bell
Thermo Fisher Scientific, South San Francisco, CA USA
P-106
Characterization of a Protein Impurity by SDS Capillary Electrophoresis
Shiao-Yan Fang
Ambrx Inc., La Jolla, CA USA
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P-107
Glycosimilarity Index for Biotherapeutics
András Guttman1, Beata Borza2, Marton Szigeti2, Akos Szekrenyes2, Laszlo Hajba3 1SCIEX, Brea, CA USA, 2University of Debrecen, Debrecen, Hungary, 3Universiy of Pannonia,
Veszprem, Hungary
P-108
icIEF Quantification of a Product-Related Impurity in an Antibody Candidate
Steve Kauffman, Jennifer Kyauk, Diya Ren
Gilead Sciences, Inc, Oceanside, CA USA
P-109
Analysis of Highly Sialylated and Low-Input Glycoprotein Samples on the GlycanAssure™
System
Shaheer Khan, Natalee Gautam, Jenkuei Liu, Bharti Solanki-Nand, Baburaj Kunnummal, Peter
Bell
Thermo Fisher Scientific, South San Francisco, CA USA
P-110
Identification and Characterization of a Thermally Cleaved Fragment of Monoclonal
Antibody-A Detected by Sodium Dodecyl Sulfate-capillary Gel Electrophoresis
Kei Kubota
Daiichi-Sankyo Co., Ltd., Hiratsuka-shi, Kanagawa, Japan
P-111
Method Development and Qualification Approach to Support the Fast-to-FIH Timelines
for Biologics: A Case Study for CE-SDS Methods
Ruiqiong Li1, Madesh Belakavadi1, Amit Katiyar2, Tapan Das1 1Bristol-Myers Squibb Company, Pennington, NJ USA, 2Bristol-Myers Squibb Company,
Hopewell, NJ USA
P-112
Quantitative Analysis of Low Molecular Weight Species (LMW) Generated During Human
IgG4 Process Development
Mengxiao Lu, Nesredin Mussa, Barry Drew
Bristol-Myers Squibb Company, Devens, MA USA
P-113
From ELISA to ELLA Plug & Play Custom Immunoassay Development with Simple Plex
to Enable Rapid, Automated, High Performance Bioprocess Analysis
Gregory Marusov
ProteinSimple, a Bio-Techne brand, Wallingford, CT USA
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P-114
Method Transferability of Capillary Isoelectric Focusing (cIEF) to Simple Western
Jiaqi Wu, Chris Heger, Annegret Boge
ProteinSimple, a Bio-Techne brand, San Jose, CA USA
P-115
Optimization of Cysteine Exchange for new THIOMAB™ Antibody Formats During
Michael Taejong Kim1, Christopher Cornell1, Yan Chen1, Fred Jacobson1 1Genentech, a Member of the Roche Group, South San Francisco, CA USA, 2Eurofins Lancaster
Laboratories, South San Francisco, CA USA
P-116
Challenges in the Determination of Amyloid Oligomeric Species by Two Electrophoretic
Techniques
Aurore Napp, Virginie Houbart, Alice Demelenne, Anne-Catherine Servais, Marianne Fillet
University of Liège, Liège, Belgium
P-117
Capillary Electrophoresis of Antiperspirant Ingredients: Characterization and
Quantification of Aluminum Chlorohydrates Oligomers
Nesrine Ouadah1, Fabien Brothier2, Jean-François Kuntz2, Claudine Moire2, Hervé Cottet1 1IBMM University of Montpellier, Montpellier, France, 2L'Oréal Research & Innovation,
Aulnay-sous-bois, France
P-118
Microfluidic Capillary Electrophoresis with Real-Time Calibration and Enhanced
Resolution for Protein Impurity Analysis
Zhiyong Peng1, White James1, Derek Troiano1, Megan Sierant1, Anubhav Tripathi2, Brian
Gerwe1 1PerkinElmer, Hopkinton, MA USA, 2Brown University, Providence, RI USA
P-119
A Capillary Based iCIEF Technology Approach to Replace Gel Based System in the
Quality Control Laboratories. Making a Transition from Gel in the QC Laboratories.
Anu Rambhadran
Regeneron Pharmaceuticals, Tarrytown, NY USA
P-120
Robust cIEF Analysis with Longer Neutral Capillary Run-Life while Maintaining High
Resolution and Reproducibility
Chitra Ratnayake1, Zaifang Zhu1, Ingrid Cruzado-Park1, David Neyer2 1SCIEX, Brea, CA USA, 2SCIEX, Redwood City, CA USA
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P-121
Fast Glycan Labeling & Analysis: High-Resolution Separation and Glycan Identification in
Minutes
Matthew Salem
SCIEX, Redwood City, CA USA
P-122
A Tale of Two CE-SDS Platforms: A Head to Head CE-SDS Assessment of the AB Sciex
PA800 Plus and the ProteinSimple Maurice Using Multiple Biologic Compounds
Kristin Schultz-Kuszak, Frank Gorelik, Eric Meinke, Xiangyang Wang
MedImmune, A member of the AstraZeneca Group, Gaithersburg, MD USA
P-123
Development of a CGE‐SDS Method for Routine Fragmentation Monitoring in a High
Complex Fusion
Natascia Sciamanna
Merck Serono, Guidonia, Italy
P-124
IgG2s and their Idiosyncrasies: Charge Assay Challenge Accepted!
Pawankumar Suresh
Genentech, a Member of the Roche Group, South San Francisco, CA USA
P-125
Inter-instrument Evaluation applying CE-SDS for Protein Analysis
Hermann Wätzig, Julia Kahle, Kai Jorrit Maul
University Braunschweig, Braunschweig, Germany
P-126
Charge Isoform Heterogeneity Analysis by Capillary Isoelectric Focusing (cIEF)
Hio (Cara) Wong, Chuck Hague, Crystal Conlan
BioMarin Pharmaceutical Inc., Novato, CA USA
P-127
Evaluation of the Maurice for Fragment Characterization by Reducing and Non-reducing
CE-SDS
Joshua Woods
Pfizer, Inc., Chesterfield, MO USA
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Deep Dive into CE
P-128
Use of a Total TCA Range in CGE (CE-SDS) Analysis of Quality Control Samples
Edith Binder
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
P-129
NISTmAb Characterization: Purity, Charge Heterogeneity and Glycan Analyses on a
Single Platform
Esme Candish, Chitra Ratnayake, Mervin Gutierrez, András Guttman
SCIEX, Brea, CA USA
P-130
Evaluation of Automated Wes System as an Analytical and Characterization Tool to
Support Monoclonal Antibody Drug Product Development
Ying-Chen Chen1, Jinyu Wang2, Anulfo Valdez1 1Bristol-Myers Squibb Company, Pennington, NJ USA, 2Rutgers University, New Brunswick, NJ
USA
P-131
Double Dipping the Chip -- Maurice as 1) An iCE3 Alternative for Existing Methods and 2)
A New Tool for Challenging Sample Types
Kelsey C. Dent, Pawankumar Suresh, David J. Fischer, David A. Michels
Genentech, a Member of the Roche Group, South San Francisco, CA USA
P-132
Evaluation of Protein Simple Maurice CE-SDS for Purity and Stability Indicating Methods
used in Process Development and Commercial Manufacturing
Abbie Esterman1, Tapan Das1, Amit Katiyar2 1Bristol-Myers Squibb Company, Pennington, NJ USA, 2Bristol-Myers Squibb Company,
Hopewell, NJ USA
P-133
The Power of Gu and the Importance of Temperature Control
András Guttman1, Marton Szigeti2, Jeff Chapman1 1SCIEX, Brea, CA USA, 2University of Debrecen, Debrecen, Hungary
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P-134
Don't We Have a Machine for That? Automated Fluorescent Labeling for CE-SDS LIF in
QC
Koman Joe, Thomas Niedringhaus, Mary Han, Jian Zhang, Sean Mojabi, Yun Tang, Sarah Du
Genentech, a Member of a Roche Group, South San Francisco, CA USA
P-135
A New, Narrow-range – High-resolution cIEF Method for High pI Molecules
Filippo Marchioni, Brian Hosken, Tony Cano
AbbVie, Inc., South San Francisco, CA USA
P-136
Enhancing Microchip Electrophoresis with Embedded Fused Silica Capillary for Cellular
Analysis
Benjamin T. Mehl, R. Scott Martin
St. Louis University, St. Louis, MO USA
P-137
Utility of Maurice cIEF Native Fluorescence in cIEF Analysis of Protein Mixtures
Jiaqi Wu, Chris Heger, Annegret Boge
ProteinSimple, a Bio-Techne brand, San Jose, CA USA
P-138
Capillary Electrophoresis of Antiperspirant Ingredients: Study of their Interaction with
Proteins
Nesrine Ouadah1, Fabien Brothier2, Jean-François Kuntz2, Claudine Moire2, Hervé Cottet3 1IBMM University of Montpellier, Montpellier, France, 2L'Oréal Research & Innovation,
Aulnay-sous-bois, France
P-139
Analytical Characterization of Protein-Polymer Conjugates used for Long Acting Delivery
Therapeutics
Cinzia Stella
Genentech, a Member of the Roche Group, South San Francisco, CA USA
P-140
A Smart Microfluidic Pharmaceutical Analysis System
Anubhav Tripathi, Adam Snider, Richard Park, Alexandra Riccardi
Brown University, Providence, RI USA
P-141
Incorporation of a Strong Acid Catalyst Addresses Labeling Bias for Afucosylated N-
linked Glycans
Jonathan van Dyck
Seattle Genetics, Inc., Bothell, WA USA
53
P-142
Characterization of a Monoclonal Antibody Minor Variant Using CE-SDS and Peptide
Mapping
Qing Zhu
Genentech, a Member of the Roche Group, South San Francisco, CA USA
54
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DoE/QbD/Life Cycle Management
P-143
Application of Analytical Quality by Design (AQbD) Approach in a Design of a Robust
mAb Non-Reduced CE-SDS Purity Method
Qian Guan, Sergey Voronov, Julia Ding, Nesredin Mussa
Bristol-Myers Squibb Company, Devens, MA USA
P-144
Quantitative Assessment and Automatic ID of Glycans of CQA Importance in Biologics
Development
András Guttman1, Marton Szigeti2, Jeff Chapman1 1SCIEX, Brea, CA USA, 2University of Debrecen, Debrecen, Hungary
P-146
The Journey to QC Readiness: A Search for a Robust Microchip CE-SDS Assay
Brian Roper¹, Zherylynn Vinyard¹, Timothy Holewinske¹, Stefanie Wohlrab², Ines Lavergne³,
Friederike Winkhaus², Thomas Niedringhaus¹
¹Genentech, a Member of the Roche Group, South San Francisco, CA USA, ²Roche Diagnostics
Charge Heterogeneity Analysis of Intact Monoclonal Antibodies using CESI-MS
Esme Candish1, Olga Friese2, Elaine Stephens3, Marshall Bern4, St John Skilton5, Jason Rouse3,
Bryan Fonslow6 1SCIEX, Brea, CA USA, 2Pfizer, Inc., Chesterfield, MO USA, 3Pfizer, Inc., Andover, MA
USA, 4Protein Metrics Inc., San Jose, CA USA, 5Protein Metrics Inc., San Carlos, CA
USA, 6SCIEX, San Diego, CA USA
P-148
Higher Order Structure of Intact Proteins by Capillary Electrophoresis Native Ion
Mobility Mass Spectrometry
Caroline Chu1, Pat Perkins1, Andy Gieschen2, Martin Greiner3 1Agilent Technologies, Santa Clara, CA USA, 2Agilent Technologies, San Diego, CA
USA, 3Agilent Technologies, Waldbronn, Germany
P-149
Orthogonal, High Resolution Polar Biomolecule Analysis by CESI-MS
Edna Betgovargez1, Esme Candish2, Bryan Fonslow3 1SCIEX, Brea, CA USA, 2SCIEX, Framingham, MA USA, 3SCIEX, San Diego, CA USA
P-150
Development and Applications of a Novel Fluorescent Dye for Glycan Labeling and
Analysis on Multi-capillary CE and CE-MS
Shaheer Khan1, Jenkuei Liu1, James Xia2, Baburaj Kunnummal1 1Thermo Fisher Scientific, South San Francisco, CA USA, 2CMP Scientific Corp., Brooklyn, NY
USA
P-151
The Study of Intact Casein as a Model System for the Separation of Intact Phosphorylated
Proteins by CESI-MS
Stephen Lock1, Edna Betgovargez2 1SCIEX, Pudsey, United Kingdom, 2SCIEX, Brea, CA USA
P-152
Characterization of Monoclonal Antibodies and Antibody Drug Conjugates using
Microchip Zone Electrophoresis-MS Technology
Erin Redman
908 Devices Inc., Carrboro, NC USA
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P-153
An Integrated Platform for N-Glycan Analysis Using Rapid Sample Preparation and 2-
Minute Separation by Capillary Electrophoresis
John Yan, Aled Jones, Michael Kimzey, Andres Guerrero, Tom Rice, Justin Hyche, Emily Dale,
Ted Haxo, Sergey Vlasenko
ProZyme, Inc, Hayward, CA USA
P-154
Automation of Gly-X Sample Prep with InstantPC and InstantQ Dyes
Ted Haxo, Emily Dale, Adele Taylor
ProZyme, Inc, Hayward, CA USA
P-155
Monitoring Glycosylation Profile and Protein Titer in Cell Culture Samples using ZipChip
CE-MS
Zoran Sosic, Peng Feng, Yan Wang, Li Zang
Biogen, Cambridge, MA USA
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Vaccines
P-156
Quantitation of CRM197 Using Imaged Capillary Isoelectric Focusing with Fluorescence
Detection and Capillary Western
Richard Rustandi, Sha Ha, John Loughney
Merck & Co., Inc., West Point, PA USA
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Late Breaking
LB-01
Micellar Electrokinetic Chromatography for Measurement of Dopamine and D-serine