The Process Research Group is involved in the research, development and optimization of Medicinal Chemistry recipes to come up with a fit-for-scaleup process. The following points are the driving force for process development and optimization of a NCE:
- Meet the regulatory requirements with respect to quality of the API
- Ease of availability of starting materials
- Ease of plant operations
- Avoid potential scale-up issues
- To eventually come up with a commercially viable process
- Synthesis of standards of impurities and metabolites
The APIs manufactured with these processes are utilized for preclinical (GLP toxicity studies) and clinical (CTS) studies.
CMC-API:
The CMC-API group is primarily responsible for delivery of API for preclinical (GLP toxicity studies) and clinical (CTS) studies.
The CMC-API takes care of:
- CROs identification including legal and financial aspects for the manufacture of API
- Coordination between the PRG and the external CRO to ensure manufacture within timelines
- API-Inventory management
- Writing and providing IND reports for regulatory submissions