ADC Platform

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Druggability assessment

  • Physicochemical characterization
  • Post-translational modification analysis
  • Stability analysis
  • Viscosity/solubility analysis
  • Pre-formulation research

Formulation development

  • DOE design
  • Storage stability study
  • Degradation pathway analysis
  • Compatibility stability study
  • Shelf-life prediction
  • Dosage form selection

Excipient screening

  • Surfactant screening
  • Stabilizer screening
  • Chelating agent screening
  • Lyoprotectant screening

Packaging material screening and compatibility study

  • Packaging method selection
  • Packaging material selection
  • Extractable/leachable analysis
  • Screening and study on lyophilized powder reconstitution

Lyophilization curve development

  • Pre-freezing method study
  • Study on drying temperature, pressure and duration
  • Parameters development for lyophilization process involving high-concentration and large-volume products
  • Parameter control range study
  • Process scale-up study

Formulation process development

  • Freeze-thaw study
  • Mixing study
  • Sterilization and filtration study
  • Filling study
  • Lyophilization study

Lyophilization curve development

  • Viscosity reducers study
  • Antioxidant study
  • Stability study
  • Freeze-thaw study, etc.

– Platform based R&D technology and process

– Personalized ADC formulation for optimal efficacy and safety

– Skillful handling of ADC drug lyophilization, maintaining activity and stability

– Quick delivery, adapt to market changes, stay competitive

– Ongoing process optimization and competitive solutions