ADC Platform

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Services

Drug substance analysis

  • Cell based activity assay method development, validation, and transfer
  • In-house reference standard characterization
  • Analytical method development, validation, and transfer
  • Drug substance release
  • Stability study

Quality study

  • Structural characterization and related substance study
  • Higher order structure analysis
  • Charge variants analysis
  • Biosimilar similarity study
  • Comparability study 

Drug product analysis

  • Analytical method development, validation, and transfer
  • Drug product release
  • Stability study
  • Packaging material compatibility study
  • Disposable material extractable/ leachable study

Other services

  • Raw materials and excipients release test
  • Microbial limit test
  • Sterility test
  • GMP facility validation and environmental monitoring support
Technical Capability
Biochemical Analysis
  • Target antibody binding affinity
  • Fc receptor binding affinity
  • Genomic copies
  • HCP/DNA/Pro-A residue assay
  • Mycoplasma test (Q-PCR)
Biological Analysis
  • Cytotoxicity test
  • Fc function test (ADCC/CDC)
  • Immunofunction test
  • Reporter gene assay
  • Gene expression
  • Viral testing
 
Physicochemical Analysis
  • Protein content
  • Purity (SEC/CE-SDS/HIC/RP)
  • Peptide mapping
  • Charge heterogeneity (IEC/iCIEF/CZE)
  • DAR (UV/HIC)
  • N-glycan profile and sialic acid
  • Residue assay (solvent/free drug for ADC)
  • Excipient component assay
Chatacterization
  • LC-MS (Intact/reduced protein, sequence, disulfide bonds, PTM, payload and drug conjugation site for ADC)
  • Molecular interaction (SPR/BLI)
  • CD, DSC
  • SEC-MALS, AUC
  • MFI
  • Free thiol
Advantages
Comprehensive platform
  • 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
  • Ability to establish detection cell lines for Sample testing
  • ADCC/CDC testing platforms
Customized method development
  • Comprehensive platform-based solutions for quality research and analysis covering monoclonal antibodies, bispecific antibodies, fusion proteins, and ADCs, etc.
  • Optimization and validation of analytical methods
Cutting-edge equipment and an elite team
  • Industry-leading instruments and equipment
  • Professional and experienced team, with core technical experts over 7 years of experience in average. Additionally, over 95% of the team members hold master’s degrees
Laboratory