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- Update of Drug Master File (DMF)
- Industrial production of API for market needs.
- Further stability testing.
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- Process validation.
- Stability studies.
- Update of CMC.
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- Forced degradation study : identification of significant impurities.
- Investigational stability study.
- Reference standard synthesis of API: Analytical qualification.
- Validation of analytical methods (monograph)
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- 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
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- Peptide characteristics: solubility studies, chemical and physical properties, conditions of purification and drying.
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- 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