Process and Analytical Method Development

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Developability evaluation and study

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

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

Screening and compatibility study of package materials

  • Packaging method selection
  • Packaging material selection
  • Extractables/leachables analysis
  • Screening and study on lyophilized powder reconstitution system

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

Process development for drug product

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

Development of high-concentration drug product

  • Study on viscosity reducer
  • Antioxidant study
  • Stability study
  • Freeze-thaw study, etc.

– Platform-based R&D technologies

– Platform-based process

– ADC preparation process development

– High-concentration protein preparation development

– Innovative dosage form development

– Rich projects experience, successfully assisted registration and filing for several products in US and China


1、Successfully solved the problem of high concentration formulation aggregation of a certain monoclonal antibody, ensuring that the project enters pilot production as scheduled.
2By optimizing the prescription components, we successfully solved the problem of impurities generated during the degradation of an ADC project and ensured that the project was declared for IND in China and the United States as scheduled.