Services
Developability assessment for drug product
-
Conformational stability study
-
Colloidal stability study
-
Stability study under accelerated and stressed conditions
-
Viscosity/Solubility analysis
Formulation development
-
Quality based on design (QbD)
-
High throughput formulation screening
-
Formulation confirmation through DoE approach
-
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
-
Reconstitution method study for lyophilized drug products
Lyophilization process development
-
Design of freezing step
-
Optimization of drying temperature, pressure and duration
-
Lyophilization parameter design for high-concentration and large-volume drug products
-
Parameter control range study
-
Process scale-up study
Fill/finish process development
-
Freeze-thaw study
-
Pooling and mixing study
-
Filtration study
-
Filling study
-
Lyophilization study
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
