drug product formulation and lyophilization process -乐鱼全站app

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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.
advantages

– 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

laboratory
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