Services
Druggability assessment
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Physicochemical characterization
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Post-translational modification analysis
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Stability analysis
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Viscosity/solubility analysis
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Pre-formulation research
Formulation development
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DOE design
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Storage stability study
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Degradation pathway analysis
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Compatibility stability study
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Shelf-life prediction
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Dosage form selection
Excipient screening
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Surfactant screening
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Stabilizer screening
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Chelating agent screening
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Lyoprotectant screening
Packaging material screening and compatibility study
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Packaging method selection
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Packaging material selection
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Extractable/leachable analysis
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Screening and study on lyophilized powder reconstitution
Lyophilization curve development
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Pre-freezing method study
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Study on drying temperature, pressure and duration
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Parameters development for lyophilization process involving high-concentration and large-volume products
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Parameter control range study
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Process scale-up study
Formulation process development
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Freeze-thaw study
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Mixing study
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Sterilization and filtration study
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Filling study
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Lyophilization study
Lyophilization curve development
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Viscosity reducers study
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Antioxidant study
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Stability study
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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