Protein/Antibody Platform

Home<Services<Protein/Antibody Platform
Return
Services

Drug substance analysis

  • Development, validation and transfer of analytical methods for drug substance
  • Characterization of in-house reference substance for biologicals
  • Development, validation and transfer of cell based activity assay methods
  • Drug substance release
  • Stability study

Quality study

  • Structural characterization of biologics and study on related substances
  • Higher order structure analysis for biologics
  • Charge variants analysis for biologics
  • Biosimilar similarity study
  • Comparability study of biologicals

Drug product analysis

  • Development, validation and transfer of analytical methods for drug product
  • Drug product release
  • Stability study
  • Compatibility study on package materials
  • Extractables/leachables study on single-use system

Other services

  • Release of raw materials and excipients
  • Microbial limit test
  • Sterility test
  • GMP facility validation and environmental monitoring support
Technical Capability
Biochemical analysis
  • Antigen-antibody binding activity assay
  • Residual HCP/DNA/Pro A test
  • Fc receptor binding activity assay
  • Gene copy number test
  • Mycoplasma test (Q-PCR)
Biological analysis
  • Cytotoxicity test
  • Fc function test (ADCC/CDC)
  • Immunofunction test
  • Report gene test
  • Gene expression determination
  • Virus content determination

Physicochemical characterization
  • Protein content
  • Purity (SEC/CE-SDS/HIC/RP)
  • Peptide map
  • Charge heterogeneity (IEC/iCIEF/CZE)
  • DAR (UV/HIC/RP)
  • N-glycan profile and sialic acid analysis
  • Residues analysis (organic solvents/free drug)
  • Excipient content analysis
Characterization
  • Liquid chromatography-mass spectrometry (LC-MS) analysis (intact/reduced molecular weight, sequence coverage, disulfide bond confirmation, and post-translational modification)
  • Liquid chromatography-mass spectrometry (LC-MS) analysis (ADC DAR value, ADC drug distribution, analysis on ADC linkage sites)
  • Molecular interaction（SPR/BLI）
  • Circular dichroism (CD), Differential scanning calorimetry (DSC)
  • Size exclusion chromatography - multi-angle light scattering (SEC-MALS) analysis, AUC
  • Micro-flow imaging (MFI)
Advantages
Comprehensive platform capabilities
  • Extensive analytical experience with antibodies, fusion proteins, ADCs/XDCs, and more.
  • Integrated platform solutions for routine quality testing.
  • Fully integrated characterization platform for in-depth quality analysis
  • Pioneering advantage of bioactivity assay:
  • Library of approximately 20 natural cell lines
  • Expertise in constructing overexpressed cell lines
  • ADCC/ADCP/CDC testing platform capabilities
Customized method development
  • Industry-leading instruments and equipments
  • Professional and experienced team, with over 95% of members holding master’s degree or higher, core technical experts have 7+ years of industry experiences.
Workshop