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Mass Spectrometry Services

We specialize in advanced mass spectrometry techniques to improve drug discovery, development, biomarker analysis, process optimization, and product characterization, offering essential insights for our clients.

  • Intact and Subunit Mass Analysis
  • Protein Amino Acid Sequence Confirmation
  • Sequence Variants Identification
  • Post-Translational Modifications (PTMs) Characterization and Monitoring
  • Disulfide Linkage Mapping
  • Glycosylation site Identification and Quantitation
  • Host Cell Protein Identification and Quantitation
  • Multi-Attribute Method (MAM) Development and Monitoring

 

  • Proteomics Study
  • De Novo Sequencing

 

  • Drug-to-Antibody Ratio (DAR) Determination
  • Free Drug and Naked Carrier Protein/Antibody Analysis

 

  • 5′ mRNA Caps Characterization
  • 3′ Poly A Tails Characterization and Quantitation

 

  • Identity Confirmation of Viral Vector

Biophysical Characterization

Our biophysical characterization services employ a variety of advanced techniques to analyze the physical and chemical properties of biomolecules. This ensures precise insights for both quality assessment and research applications.

  • Circular Dichroism (CD)
  • Differential Scanning Calorimetry (DSC)
  • Analytical Ultracentrifugation (AUC)
  • Dynamic Light Scattering (DLS)
  • Size-Exclusion Chromatography with Multi-Angle Light Scattering (SEC-MALS)
  • MicroFlow Imaging (MFI)
  • Light Obscuration (LO)

Analytical Method Development And Samples Testing

Our analytical method development and testing services cover a wide range of methods and technologies, ensuring accurate results for quality control and research purposes.

  • HPLC/UPLC
  • CE
  • SDS-PAGE
  • HCP ELISA
  • Residual ProA ELISA
  • Residual DNA qPCR

Regulatory Filing

We offer a comprehensive analytical data package designed to assist our clients in achieving successful regulatory submissions at multiple stages.

  • Elucidation of Structure
  • Impurity Profiling
  • Accelerated Stress and Forced Degradation Study
  • Variants collection and in-depth characterization
  • Critical Quality Attributes Assessment
  • Reference Standard Characterization
  • Stability Profiling
  • Comparability Study

Consulting

We offer consulting services in analytical development, product characterization, evaluation of critical quality attributes (CQAs) and guidance on MAM strategies.

  • Developability Assessment
  • Analytical Method Development
  • Product Characterization
  • Critical Quality Attributes (CQAs) Assessment MAM strategies and Development
  • Mass Spectrometry Data Interpretation
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