Route Scouting is an essential step in the drug development process, critical to the cost effective and safe manufacturing of a drug substance. It is routinely the case that the route of synthesis used during the preclinical stage may not be feasible or optimum for large scale manufacturing
Synthetic route scouting focuses on discovering the most feasible, cost effective, and safest way to commercially viable scaled manufacturing of a drug. This includes a responsibility to fully consider all environment, health, and safety (EH&S) concerns.
Proper and thorough route scouting will:
- Develop new synthetic routes for target molecules
- Separate and structure determination of impurities.
- Provide routing validation
- Promote cost and time efficiency to decrease cost of API
- Apply innovations to maintain relevance
- Reduce number of steps for key intermediates
- Place EH&S considerations at highest level of priority