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Representative Posters and Publications

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, USA

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

Xiaomei (Annie) 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, USA

LC-MS Based HCP Monitoring During Biologic Downstream Process Development

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

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

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

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

Serah Liu, Chen Li, and Billy Wu of BioAnalytix, Inc. Cambridge, MA, USA

Douglas Richardson, Yan‐Hui Liu, and Huijuan Li of Merck Research Laboratories Kenilworth, NJ, USA

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

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

Peter Li and Shiaw-Lin (Billy) Wu of BioAnalytix

Lionel Sison, Scott Li and Bernice Yeung of Shire

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

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

Yaping Sun, Peter Li, and Billy Wu of BioAnalytix

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

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

2016

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

Jia Zhao*,†, Siyang Li, Chen Li, Shiaw-Lin Wu, Wei Xu, Yuetian Chen, Mohammed Shameem, Douglas Richardson§, and Huijuan Li

Merck Research Laboratories, 2000 Galloping Hill Road, Kenilworth, New Jersey 07033, United States; BioAnalytix, Inc., Cambridge, Massachusetts 02139, United States

Analytical Chemistry

Assessing in vivo dynamics of multiple quality attributes from a therapeutic IgG4 monoclonal antibody circulating in cynomolgus monkey

Yinyin Li1*, Yu Huang1, Janine Ferrant1, Yelena Lyubarskaya1, Emma Zhang2, Peter Li2, Billy Wu2

1 Biogen, Cambridge, MA 02142. 2BioAnalytix Inc, Cambridge, MA 02139.

mAbs

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

Emma Zhang1, Yinyin Li2, Peter Li1, Yu Huang2, Patrick Swann2, Yelena Lyubarskaya2, Billy Wu1

1BioAnalytix Inc, Cambridge, MA 02139. 2Biogen Idec, Cambridge, MA 02139.

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

2015

Understanding of Critical Quality Attributes of Biopharmaceuticals In Vivo

Yinyin Li1, Emma Zhang2, Peter Li2, Billy Wu2, Patrick Swann1, Yelena Lyubarskaya1

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

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

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

Janet Lau; Siyuan (Serah) Liu; Yue (Emma) Zhang; Lily Li; Billy Wu

BioAnalytix, Inc., Cambridge, MA

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

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

Peter Li1, Terry Zhang2, Jonathan Josephs2, Emma Zhang1, Chen Li1, and Billy Wu1

1BioAnalytix, Inc., Cambridge, MA; 2ThermoFisher Scientific, San Jose, CA

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 Li1, Peter Li1, Wei Xu2, Douglas Richardson2, Xiaodun Mou2, Huijuan Li2, Yuetian Chen2, Daisy Richardson2, Mohammed Shameem2, David Pollard2 and Shiaw-Lin Wu1

1BioAnalytix, Inc., Cambridge, MA, USA; 2Merck & Co. Kenilworth, NJ, USA

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

Serah Liu2, Li Zang3, Andrew Weiskopf3, Chen Li1, and Shiaw-Lin Wu1,2

1BioAnalytix Inc., Cambridge, MA, USA; 2Barnett Institute, Northeastern University, Boston, MA, USA; 3Biogen Idec, Cambridge, MA, USA

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

2014

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

Chen Li1, Anna Zhang2, Serah Liu2, Peter Li1, Julian Saba3, Zhiqi Hao3, Shiaw-Lin Wu1

1BioAnalytix, Cambridge, MA USA 2Barnett Institute, Northeastern University, Boston, MA, USA; 3ThermoFisher Scientific, San Jose, CA, USA

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

Sequence Variation and Comparability Analysis of Protein Therapeutics

Chen Li1, Anna Zhang2, and Shiaw-Lin Wu1

1BioAnalytix Inc., Boston, MA, USA; 2Barnett Institute, Northeastern University, Boston, MA, USA

Well Characterized Biologic Pharmaceuticals (WCBP), Washington, DC, USA

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

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

2013

Opportunities in Advanced Analytic Profiling of Complex Biologic Therapeutics

Shiaw-Lin Wu

BioAnalytix Inc., Boston, MA, USA

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

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

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

1Barnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, MA, USA; 2Alnylam Pharmaceuticals, Cambridge, MA, USA

mAbs

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, Taylor AD2, Lu Q1, Hanash SM2, Im H3, Snyder M3, Hancock WS1

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

Molecular and Cellular Proteomics

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

Q. Lu1, V. Padler-Karavani2, H. Yu2, X. Chen2, Shiaw-Lin Wu1, A. Varki2, W.S.Hancock1

1Barnett Institute and Department of Chemistry and Chemical Biology, Northeastern University, Boston, MA, USA; 2Glycobiology Research and Training Center, Departments of Medicine and Cellular & Molecular Medicine, University of California San Diego, La Jolla, CA, USA.

Analytical Chemistry

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 and Department of Chemistry and Chemical Biology, Northeastern University, Boston, MA, USA; 2Shire Human Genetic Therapies, Inc., Lexington, MA, USA

Journal of the American Society for Mass Spectrometry

Ultrasensitive capillary electrophoretic analysis of potentially immunogenic carbohydrate residues in biologics: galactose-α-1,3-galactose containing oligosaccharides

Szabo Z, Guttman A, Bones J, Shand RL, Meh D, Karger BL

Barnett Institute, Northeastern University, Boston, MA, USA

Molecular Pharmaceutics

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