Process and Analytical Method Development

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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
  • Integrated platform solutions for quality research and analysis of monoclonal antibodies, bispecific antibodies, fusion proteins, ADCs, etc.
  • Pioneering advantage: Around 20 detection method platforms for tumor cell detection, providing report gene method testing
  • Ability to build detection cell lines for sample testing
  • 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.
Workshop