ADC Integrated Platform

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Services

Drug substance analysis

  • Development, validation and transfer of analytical methods for drug substance
  • In-house reference standard characterization
  • 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 biologics

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
  • Reporter gene assay
  • Gene expression determination
  • Virus content determination
 
Physicochemical analysis
  • 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
  • Analysis of intact/reduced molecular weight, sequence coverage, disulfide bond confirmation, and post-translational modification by LC-MS
  • Analysis of ADC DAR value, ADC drug distribution, analysis on ADC linkage sites by LC-MS
  • 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)
  • Free thiol
Advantages
Comprehensive platform capabilities
  • Integrated platform solutions for quality research and analysis of monoclonal antibodies, bispecific antibodies, fusion proteins, ADCs, etc.
  • Around 20 tumor cell lines in platform for bioassay, providing reporter gene assay test
  • Ability to develop and prepare non-production cell lines/indicator cell lines for bioassay
  • ADCC/CDC testing platforms capabilities
Customized method development
  • Comprehensive platform-based solutions for quality research and analysis covering monoclonal antibodies, bispecific antibodies, fusion proteins, and ADCs, etc., with the capability to customize and optimize testing methods based on clients’ specific targets
  • Further optimization and validation of analytical methods after method transfer from customer
Cutting-edge equipment and an elite team
  • Industry-leading instruments and equipment
  • Professional and experienced team, with core technical experts with 7 years of experience in average. Additionally, over 95% of the team members hold master’s degrees
Laboratory