We have a highly professional, resource-rich and flexible R&D team that can provide customers with customized drug substance services, including but not limited to generic drug substance, pre-clinical study of new drugs, clinical phase III and technology transfer, commercial production, etc. Our team can support your product at every stage of the life cycle.

What we can provide for the development of the drug substance includes:

• Process route design and optimization
• DOE parameter screening and operation space confirmation
• Laboratory and pilot scale-up
• Quality studies (genotoxic, elemental impurities)
• Analytical control preparation and characterization
• Process validation and method validation, transfer
• Ongoing process tracking and optimization
• CGMP commercial manufacturing
• ICH stability study
• Global Registration (CEP/MF/DMF/drug substance filing)

Knowledge of the physical properties of active pharmaceutical ingredients (APIs) is essential to obtain developable solid forms, and by discovering the most suitable crystalline forms, the stability, solubility, bioavailability and processability of APIs can be improved to reduce the risk of pharmaceutical products. We aimed to determine the crystallization process of the drug substance, obtain compounds of consistent quality that can be scaled up for reprocessing and characterization to meet the requirements of the drug substance for different dosage forms.

• Crystallization process screening
  • Salt type screening
  • Cocrystal screening
  • Screening of crystal forms
  • Recrystallization process screening
  • Study on particle morphology
• Powder reprocessing
  • Spray drying
  • Amorphous solids dispersing system
  • Ball milling and micronization of high energy medium
  • Processing and production of sterile/non-sterile drug substance powder
• Powder characterization
  • Bulk density
  • Thermal analysis
  • Specific surface area
  • Particle-size distribution
  • Scanning electron microscope
  • Raman spectrometry
  • Powder X-ray diffraction
  • Single-crystal X-ray diffraction

• Prescription screening and optimization
• Compatibility study data of drug substance and excipients
• Comparator reverse engineering
• Process parameter screening and operation space qualification
• Small-scale and pilot scale-up
• Comprehensive quality study
• Stability study
• Conventional dosage forms (solid preparations, injections, etc.)
• Complex dosage forms (suspension, inhalation, etc.)
• ANDA registration application of China, USA, Europe and Japan

• Development of analytical methods
• Preparation of impurity separation
• Identification and characterization of impurities
• Quantitative value assignment of control
• Method transfer, qualification and validation
• Drug substance release testing
• Release testing of finished drug product
• Microbiological, sterility and endotoxin testing