Step 1 Feasibility studies
- Synthesis route studies and manufacturing processes
- Process development to define an economical and scalable process
- Development of first analytical method, chemical analysis, and structure determination for the peptide API
Step 2 Preclinical studies
- Peptide characteristics: solubility studies, chemical and physical properties, conditions of purification and drying.
Step 3 Clinical trial phase 1
- Specifications of API and raw materials.
- GMP production for first in man clinical trials.
- First analytical protocols for critical step of synthesis.
- Qualification of API analytical methods.
- First stability studies of API.
- CMC (chemistry manufacturing and controls) preparation pour IND and IMPD
Step 4 Clinical trial phase 2
- Forced degradation study : identification of significant impurities.
- Investigational stability study.
- Reference standard synthesis of API: Analytical qualification.
- Validation of analytical methods (monograph)
Step 5 Clinical trial phase 3
- Process validation.
- Stability studies.
- Update of CMC.
Go to market
- Update of Drug Master File (DMF)
- Industrial production of API for market needs.
- Further stability testing.
