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Representative Posters and Publications

2018

On-Demand Manufacturing of Clinical-Quality Biopharmaceuticals

Laura Crowell1,2, Amos Lu2, Kerry Love1, Alan Stockdale1, Steven Timmick3,4,5, Di Wu6, Yu (Annie) Wang6, William Doherty1, Alexandra Bonnyman1, Nicholas Vecchiarello3,4, Chaz Goodwine3,4, Lisa Bradbury7, Joseph Brady1,2, John Clark1,8, Noelle Colant1,2,9, Aleksandar Cvetkovic7,10, Neil Dalvie1,2, Diana Liu1, Yanjun Liu6, Craig Mascarenhas1,11, Catherine Matthews1,2, Nicholas Mozdzierz1,2, Kartik Shah1, Shiaw-Lin Wu12, William Hancock6, Richard Braatz2, Steven Cramer3,4, Christopher Love1,2

1Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA; 2Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, MA; 3 Department of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, NY; 4Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute, Troy, NY; 5GlaxoSmithKline, King of Prussia, PA; 6Barnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, MA; 7Pall Life Sciences, Westborough, MA; 8Biogen, Cambridge, MA; 9Department of Biochemical Engineering, University College London, London; 10Sanofi, Framingham, MA; 11Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA; 12BioAnalytix, Cambridge, MA.

Nature Biotechnology

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Profiling Biologic Drug Interactions with Small Molecules Using Both Native MS and HDX-MS

Xiaomei He, Siyang Li, Yue Zhang, Wanlu Qu, Chen Li, Shiaw-Lin Wu of BioAnalytix

American Society of Mass Spectrometry (ASMS), San Diego, CA

Analytical Comparability Study of Recombinant Monoclonal Antibody Therapeutics

Alexandre Ambrogelly1, Stephen Gozo2, Amit Katiyar3, Shara Dellatore4, Yune Kune5, Ram Bhat6, Joanne Sun7, Ning Li8, Dongdong Wang9, Christine Nowak10, Alyssa Neill10, Gomathinayagam Ponniah10, Cory King10, Bruce Mason10, Alain Beck11, Hongcheng Liu10

1Gilead Sciences, Oceanside, CA; 2Celgene Corporation, Summit, NJ; 3Bristol-Myers Squibb, Pennington, NJ; 4Merck Research Laboratories, Kenilworth, NJ; 5Fortress Biologicals, Waltham, MA; 6Millennium Research Laboratories, Woburn, MA; 7Innovent Biologics, Suzhou, China; 8Regeneron Pharmaceuticals, Tarrytown, NY; 9BioAnalytix, Cambridge, MA; 10Alexion Pharmaceuticals, New Haven, CT; 11Center d’Immunologie Pierre Fabre, St. Julien-en-Genevois, France

mAbs

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Determination of Higher Order Structure Comparability for a Highly Glycosylated Protein by Advanced HDX-MS Approaches

Peter Li, Chen Li, Shiaw-Lin Wu of BioAnalytix

Lionel Sison, Scott Li, Bernice Yeung of Shire

Biotherapeutics Analytical Summit, Baltimore, MD

Characterization of Low-concentration Biologic Drug and Compatibility in Small Molecule Drug Admixtures by Advanced LC-MS Approach

Xiaomei He, Wanlu Qu, Dongdong Wang, Jennifer S. Chadwick, Shiaw-Lin Wu of BioAnalytix

Nazila Salamat-Miller, Paul A. Salinas of Shire

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

Determination of the Complex Disulfide Connectivity in a Binding Protein of Insulin-like Growth Factor-1

Chen Li, Serah Liu, Shiaw-Lin Wu of BioAnalytix

Paul A. Salinas, Justin Prien, Chris Barton of Shire

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

2017

Determination of the Complex Disulfide Connectivity in a Binding Protein of Insulin-like Growth Factor-1

Chen Li, Serah Liu, Shiaw-Lin Wu of BioAnalytix

Paul A. Salinas, Justin Prien, Chris Barton of Shire

14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry, Boston, MA

Robust Quantitation of a Low-concentration Biologic Using LC-MS

Xiaomei He, Wanlu Qu, Dongdong Wang, Jennifer S. Chadwick, Shiaw-Lin Wu of BioAnalytix

Nazila Salamat-Miller, Paul A. Salinas of Shire

14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry, Boston, MA

LC-MS Based HCP Monitoring During Biologic Downstream Process Development

Chen Li, Wanlu Qu, Serah Liu, Shiaw-Lin Wu of BioAnalytix

Fengqiang Wang, Yan-Hui Liu, Doug Richardson, Daisy Richardson of Merck Research Laboratories

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

Determination of Disulfide Connectivity of a Glycosylated Insulin‐like Protein by Top‐down LC‐MS with ETD Analysis

Serah Liu, Chen Li, Shiaw-Lin Wu of BioAnalytix

Douglas Richardson, Yan‐Hui Liu, Huijuan Li of Merck Research Laboratories

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

Determination of Higher Order Structure Comparability for a Highly Glycosylated Protein by Advanced HDX-MS Approaches

Peter Li, Shiaw-Lin Wu of BioAnalytix

Lionel Sison, Scott Li, Bernice Yeung of Shire

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

HDX‐MS Higher Order Structure Profiling of Somavaratan, a Novel Long‐Circulating rhGH Therapeutic

Yaping Sun, Peter Li, Shiaw-Lin Wu of BioAnalytix

Eric Mueller, Xiao Liu, Gary Koe, Patrick Murphy of Versartis

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

2016

Identification of Low Abundant Isomeric Glycan Structures in Biological Therapeutics by LC/MS

Jia Zhao1, Siyang Li2, Chen Li1, Shiaw-Lin Wu2, Wei Xu1, Yuetian Chen1, Mohammed Shameem1, Douglas Richardson1, Huijuan Li1

1Merck Research Laboratories, Kenilworth, NJ; 2BioAnalytix, Cambridge, MA

Analytical Chemistry

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Assessing In Vivo Dynamics of Multiple Quality Attributes from a Therapeutic Monoclonal Antibody Circulating in Cynomolgus Monkey

Yinyin Li1, Yu Huang1, Janine Ferrant1, Yelena Lyubarskaya1, Emma Zhang2, Peter Li2, Shiaw-Lin Wu2

1Biogen, Cambridge, MA; 2BioAnalytix, Cambridge, MA

mAbs

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Mapping Critical Quality Attributes of a Biopharmaceutical In Vivo by Unique Affinity Purification and Advanced LC-MS Methods

Emma Zhang, Peter Li, Shiaw-Lin Wu of BioAnalytix

Yinyin Li, Yu Huang, Patrick Swann, Yelena Lyubarskaya of Biogen

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

2015

Understanding of Critical Quality Attributes of Bipharmaceuticals In Vivo

Yinyin Li, Patrick Swann, Yelena Lyubarskaya of Biogen

Emma Zhang, Peter Li, Shiaw-Lin Wu of BioAnalytix

American Society of Mass Spectrometry (ASMS), St Louis, MO

Robust Peptide Mapping for Lot Release of Therapeutic Proteins Using an Advanced LC-UV-MS Approach

Janet Lau, Siyua Liu, Yu Zhang, Lily Li, Shiaw-Lin Wu of BioAnalytix

American Society of Mass Spectrometry (ASMS), St Louis, MO

Advanced LC-MS Based Characterization and Higher Order Structure Analysis by HDX-MS for Orthogonal Determination of CQA’s in Biologic Drugs

Peter Li, Emma Zhang, Chen Li, Shiaw-Lin Wu of BioAnalytix

Terry Zhang, Jonathan Josephs of Thermo Fisher Scientific

CASSS Higher Order Structure, Boston, MA

Advanced LC-MS Based Approaches for Orthogonal Determination of N- and O-linked Glycosylation Structures in Therapeutic Proteins

Chen Li, Peter Li, Shiaw-Lin Wu of BioAnalytix

Wei Xu, Douglas Richardson, Xiaodun Mou, Huijuan Li, Yuetian Chen, Daisy Richardson, Mohammed Shameem, David Pollard of Merck Research Laboratories

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

Analysis of Cystine Knots in a Protein Biopharmaceutical using LC-MS with Electron Transfer Dissociation and a Stabilizing Sample Pretreatment

Chen Li, Shiaw-Lin Wu of BioAnalytix

Serah Li of Barnett Institute, Northeastern University

Li Zang, Andrew Weiskopf of Biogen

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

2014

Advanced LC-MS Based Characterization for Determination of Critical Quality Attributes in Therapeutic Proteins

Chen Li, Peter Li, Shiaw-Lin Wu of BioAnalytix

Anna Zhang, Serah Liu of Barnett Institute, Northeastern University

Julian Saba, Zhiqi Hao of Thermo Fisher Scientific

American Society of Mass Spectrometry (ASMS), Baltimore, MD

Sequence Variation and Comparability Analysis of Protein Therapeutics

Chen Li, Shiaw-Lin Wu of BioAnalytix

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC

Thermo Fisher Scientific and BioAnalytix Collaborate to Develop Advanced Biopharmaceutical Analysis Workflows

San Jose, California – (June 11, 2014) – Scientists at Thermo Fisher Scientific and BioAnalytix, of Cambridge, MA, are combining their expertise to develop advanced analytical profiling platforms and applications to characterize biologic and biosimilar drugs.
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2013

Opportunities in Advanced Analytic Profiling of Complex Biologic Therapeutics

Shiaw-Lin Wu of BioAnalytix

American Academy of Pharmaceutical Scientists (AAPS), San Antonio, TX

Comparability Analysis of Anti-CD20 Commercial (Rituximab) and RNAi-mediated Fucosylated Antibodies by Two LC-MS Approaches

Chen Li1 Anthony Rossomando2, Shiaw-Lin Wu1, Barry L. Karger1

1Barnett Institute, Northeastern University, Boston, MA; 2Alnylam Pharmaceuticals, Cambridge, MA

mAbs

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Identification of Potential Glycan Cancer Markers with Sialic Acid Attached to Sialic Acid and Up-regulated Fucosylated Galactose Structures in Epidermal Growth Factor Receptor Secreted from A431 Cell Line

Shiaw-Lin Wu1, Allen D. Taylor2, Qiaozhen Lu1, Samir M. Hanash2, Hogune Im3, Michael Snyder3, William S. Hancock1

1Barnett Institute, Northeastern University, Boston, MA; 2Fred Hutchinson Cancer Research Center, Seattle, WA; 3Stanford University School of Medicine, Palo Alto, CA

Molecular and Cellular Proteomics

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2012

LC-MS Analysis of Polyclonal Human Anti-Neu5Gc xeno-autoantibodies Immunoglobulin G Subclass and Partial Sequence Using Multistep Intravenous Immunoglobulin Affinity Purification and Multienzymatic Digestion

Qiaozhen Lu1, Vered Padler-Karavani2, Hai Yu2, Xi Chen2, Shiaw-Lin Wu1, Ajit Varki2, William S. Hancock1

1Barnett Institute, Northeastern University, Boston, MA; 2Glycobiology Research and Training Center, University of California San Diego, La Jolla, CA

Analytical Chemistry

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Complete Mapping of a Cystine Knot and Nested Disulfides of Recombinant Human Arylsulfatase A by Multi-Enzyme Digestion and LC-MS Analysis Using CID and ETD

Wenqin Ni1, Melanie Lin2, Paul Salinas2, Philip Savickas2, Shiaw-Lin Wu1, Barry L. Karger1

1Barnett Institute, Northeastern University, Boston, MA; 2Shire, Lexington, MA

Journal of the American Society for Mass Spectrometry

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Ultra-sensitive Capillary Electrophoretic Analysis of Potentially Immunogenic Carbohydrate Residues in Biologics: Galactose-α-1,3-Galactose Containing Oligosaccharides

Zoltan Szabo1, Andras Guttman1, Jonathan Bones1, Randi L. Shand2, David Meh2, Barry L. Karger1

1Barnett Institute, Northeastern University, Boston, MA; 2United Therapeutics Corporation, Washington DC

Molecular Pharmaceutics

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