Develop MS methods for structural characterization of antibodies, including intact mass analysis, protein sequencing, PTM analysis, and native MS methods
Lead bispecific antibody forced degradation studies, pre-formulation studies, and developability studies
Lead B-body bispecific antibody platform characterization
Senior R&D Scientist
Scientific Protein Laboratories
02.2021 - 09.2021
Optimizing process to purify defibrotide from swine intestine mucosa
Establish lab scale process for crude DNA isolation from Peptone
Develop and perform numerous analytical assays (SEC-UV, SECMALS, SAX HPLC, relative potency, DNA content) on the acid digested DNA to determine processing equivalency to reference standard of defibrotide
Senior Scientist
Catalent Pharma Solutions
02.2016 - 12.2020
Create the LCMS laboratory and lead mass spectrometry group
Develop LCMS platform assays to characterize critical attributes of monoclonal antibodies, including sequence confirmation, sequence variant identification, qualitative and quantitative analysis of post-translational modifications
Develop LCMS based analytical characterization strategies to support drug development activities, including clone selection, upstream condition optimization, downstream purification optimization, forced degradation and comparability studies
Oversee analytical techniques for biologics release/characterization tests, including LC/MS, HPLC (SEC, RP, HIC, and IEX), and CE
Implement CD, DSC, DLS, CE instruments and methods to expand department capability
Lead mAb formulation, stability, forced degradation, and comparability studies
Senior Scientist
Pharmaceutical Product Development (PPD)
05.2015 - 02.2016
Develop and validate LC-UV-MS methods to separate and quantify proteins and peptides
Write project proposals/plans
Researcher
University of Wisconsin-Madison
03.2013 - 04.2015
Develop and validate LC/MS methodologies to extract, separate, and quantify polyphenols in plants
Develop MALDI-TOF MS to identify anthocyanidin chemical structures
Develop Super Fluidic Chromatography (SFC) to separate anthocyanidin polymers
Education
Ph.D. - Analytical Chemistry
Brigham Young University
Provo, UT, USA
01.2011
Post-doctoral Research - undefined
University of Wisconsin-Madison
Madison, WI, USA
02.2013
Skills
Extensive expertise in leading LCMS method development to characterize antibodies
Proficient in LC method development, qualification, and validation for antibodies
Lead a team to characterize antibodies, perform forced degradation and formulation studies
Ability to work in a high-paced team environment and in cross functional teams
Enthusiasm in science and technology, excellent written and verbal communication skills
Timeline
Principal Scientist
Invenra
11.2021 - Current
Senior R&D Scientist
Scientific Protein Laboratories
02.2021 - 09.2021
Senior Scientist
Catalent Pharma Solutions
02.2016 - 12.2020
Senior Scientist
Pharmaceutical Product Development (PPD)
05.2015 - 02.2016
Researcher
University of Wisconsin-Madison
03.2013 - 04.2015
Post-doctoral Research - undefined
University of Wisconsin-Madison
Ph.D. - Analytical Chemistry
Brigham Young University
Publications
Chen, X. et al. Investigation of Dimers in Bispecific antibody Generated by B-Body Platform Using Native Mass Spectrometry, Manuscript in preparation, Journal of the American Society for Mass Spectrometry
Chen, X. et al. Acidic and Basic Charge Variants Characterization of Bispecific antibody Generated by B-Body Platform, Manuscript in preparation, Journal of Pharmaceutical Science
Chen, X. et al. Forced Degradation Study Revealed Distinct Stability of Bispecific Antibody Generated by B-Body Platform, Manuscript in review, Journal of Pharmaceutical and Biomedical Analysis
Chen, X.; Parker, J.; Reed, J. et al. Validation of HPLC Assay for the Identification and Quantification of Anthocyanins in Black Currants. Analytical Methods, 2014, 6, 8141-8147.
Peng, Y.; Chen, X.; Ge, Y. et al. In-Depth Proteomic Analysis of Human Troponyosin by Top-down Mass Spectrometry, Journal of Muscle Research and Cell Motility, 2013, 34, 199-210.
Chen, X.; Ge, Y. High-Resolution SEC for Top-Down Proteomics, Proteomics, 2013, 13, 2563-2566.
Peng, Y.; Chen, X.; Ge, Y. et al. Top-Down Targeted Proteomics for Deep Sequencing of Tropomyosin Isoforms, Journal of Proteomics Research, 2013, 12, 187-198.
Chen, X.; Peng, Y.; Ge, Y. et al. Rapid Purification and High-Resolution MS Characterization of Human Salivary Amylase, Analytical Chemistry, 2012, 84, 3339-3346.
Chen, X.; Tolley, H. D.; Lee, M. L. Monolithic Capillary Columns Synthesized from a Single Phosphate-Containing Dimethacrylate Monomer for Cation-Exchange Chromatography of Peptides and Proteins. Journal of Chromatography A, 2011, 1218, 4322-4331.
Chen, X.; Tolley, H. D.; Lee, M. L. Weak Cation-Exchange Monolithic Column for Capillary Liquid Chromatography of Peptides and Proteins. Journal of Separation Science, 2011, 34, 2063-2071.
Chen, X.; Tolley, H. D.; Lee, M. L. Preparation of Zwitterionic Polymeric Monolithic Columns for Hydrophilic Interaction Capillary Liquid Chromatography. Journal of Separation Science, 2011, 34, 2088-2096.
Chen, X.; Tolley, H. D.; Lee, M. L. Polymeric Cation-Exchange Monolithic Columns Containing Phosphoric Acid Functional Groups for Capillary Liquid Chromatography of Peptides and Proteins. Journal of Chromatography A, 2010, 1217, 3844-3854.
Chen, X.; Tolley, H. D.; Lee, M. L. Polymeric Strong Cation-Exchange Monolithic Column for Capillary Liquid Chromatography of Peptides and Proteins. Journal of Separation Science, 2009, 32, 2565-2573.