Telephone sharing button Contact Us linkedin sharing button LinkedIn wechat sharing button YouTube wechat sharing button Twitter mailbox sharing button
arrow_left sharing button
arrow_right sharing button

Mass Spectrometry Characterization

Structural characterization of biopharmaceuticals is critical to ensure product quality and lot-to-lot consistency throughout the entire product development lifecycle. The Mass Spectrometry Center of Excellence (MS CoE) at WuXi Biologics provides world leading mass spectrometry services for product quality attribute research, impurity identification and quantitation to support process development and optimization and product manufacture.


Using state-of-the-art instruments and leveraging the expertise of our mass spectrometry specialists, we provide analytical testing services for a wide range of molecular modalities, including, but not limited to, monoclonal and bispecific antibodies, fusion proteins, enzymes, other recombinant proteins including subunit vaccines, antibody drug conjugates (ADCs) and polypeptides. We have supported over 500 integrated DNA to IND projects, late-stage clinical programs and standalone analytical projects to date. As a trusted partner, we provide scientific expertise and technical solutions to our global pharmaceutical customers in order to efficiently advance their products into the clinic and beyond.



Our core business areas include:


  • Structural characterization of therapeutic proteins in preclinical and clinical development as part of quality attribute studies
  • Innovative MS method development focusing on qualitative and quantitative analysis of critical quality attributes (CQAs)
  • Product and process-related impurity (e.g., host cell proteins) identification
  • Peptide mapping method development for lot release testing
  • Standalone project support throughout discovery and CMC development project phases

MS CoE offers full-service solutions customized for protein therapeutics at all stages of development from preclinical to licensure. Our mass spectrometry services include but not limited to the following:

Assay Instrumentation

Testing Purpose

Intact/Subunit Mass Analysis (w/o Deglycosylation, w/o Reduction) UPLC (UHPLC)-MS with Time-of-Flight (TOF) Verification of Protein Sequences, Major PTMs and Assembly at Intact/Subunit Level
Native Mass Analysis Determination of DAR Value and Conjugation Profiles on ADC
Mass Analysis
MADLI-TOF Verification of Protein Assembly at Intact Level
Assay Instrumentation

Testing Purpose

Sequence Coverage UHPLC-MS/MS (with Orbitrap) Confirmation of Amino Acid Sequence
Sequence Variant Analysis Identification of Sequence Variant
N/C-Terminal Sequence Confirmation Confirmation of N/C-Terminal Sequence Integrity
Post Translational Modification (PTM) Analysis Determination of PTM Sites and Ratios
N/O-Linked Glycosylation Profile Analysis Identification and Quantitation of Site-Specific N/O-Linked Glycosylation Profile
N/O-Linked Glycosylation Site Confirmation Identification of N/O-Linked Glycosylation Site
Conjugation Site Analysis Determination of Conjugation Site and Site Occupancy
Disulfide Linkage Analysis Identification of Expected and Scrambled Disulfide Linkages and Determination of Cysteine-related Variants
Assay Instrumentation

Testing Purpose

SEC/IEX/RP/HIC Variant Characterization (w/o Peak Fractionation) UPLC (UHPLC)-MS (with TOF) and UHPLC-MS/MS (with Orbitrap) Combination with Physiochemical Assays and Biological Assays to Extend Knowledge and Assessment on Product Quality Attributes
Charge Variant Analysis CZE/CIEF/2-dimentional UHPLC Online Coupled with HRMS (TOF or Orbitrap) Identification of the Composition of Charge Heterogeneity
Assay Instrumentation

Testing Purpose

HCP-MS Profiling UHPLC-MS/MS (with Orbitrap) Qualitative Identification and Relative Quantitation of HCPs
Targeted Protein Quantitation by Parallel Reaction Monitoring MS Absolute Quantitation of Specific Proteins
Assay Instrumentation

Testing Purpose

Method Development UHPLC-MS/MS with Orbitrap and UPLC (UHPLC) Method Development and Transfer for Identification of Target Protein Product
Release Testing UPLC (UHPLC) Releasing Testing of non-GMP Samples



Contact us to learn more about our Mass Spectrometry Characterization services and our other Centers of Excellence.