Innovative Drug Process Research Service

Our company provides pre-clinical and clinical-stage innovative drug process development, optimization, and manufacturing services for our customers. In accordance with the most recent standards and guidelines, we have constructed a GMP-compliant API research platform and successfully developed GMP APIs for clinical trials for innovative drug firms as well as APIs for novel medications for various pharmaceutical businesses.

Service Overview

Our company's services for innovative drug process research include, but are not limited to, the following.

Customized Initial Material Services

Synthesis Process Research Services:

• Route design and identification
• Process optimization:
  (1) Optimization of critical process parameters
  (2) Establishment of quality standards for raw materials, intermediates and finished products
  (3) Establishment of intermediate control standards
  (4) Heterogeneous mass spectrometry studies

• Impurity/Specimen Preparation and Standardization:
  (1) API specimen preparation and standardization
  (2) Preparation and standardization of raw material and intermediate specimens
  (3) Impurity specimens (preparation or purchase of impurities; structural confirmation and standardization if necessary, 10 mg-500 mg of impurities)
• 1 batch of small trial process confirmation
• Safety assessment batch 1 batch (toxicology batch (non-GMP))
• Pilot scale up production 2 batches (pilot batch (non-GMP))
• GMP production 1 batch (cGMP batch production)

Quality Studies Services:

• Establishment of draft material quality standards
• Analytical method development and optimization
• Material testing and release
• Central control analysis
• Analytical method validation

Stability Studies Services:

• Influencing factor experiments (1 month)
• Accelerated stability (6 months)
• Long-term stability (tentative 24 months)

Crystallographic Screening and Crystallographic Process Development Services:

• Crystallographic screening
• Crystallographic process study

Our company generally uses X-ray powder diffraction (XRPD mapping) to determine the crystalline shape for drug polymorph structure analysis.

If you want to know more about service details, please feel free to contact us.

It should be noted that our service is only used for research, not for clinical use.