This service provides chemical synthesis of lead compounds for use in additional drug development studies. Compounds must previously have been successfully synthesized to be candidates for this service. Synthesis of new analogs is not supported.
Main Areas of Focus
- To fill specific gaps in an investigator’s drug development plan as they advance their product toward clinical investigation
- To help investigators obtain data to get additional funding
- To help with prospective partnerships
- To help with getting regulatory permission to continue
- Investigators provide the synthetic schemes to be followed; NIAID contractors will modify or optimize problematic steps as necessary.
- Complexity and cost will limit potential scale-up efforts, but synthesis of up to 1 kilogram of a simple small molecule often can be accommodated.
- Drug substances can be synthesized under Good Manufacturing Practice (GMP) guidelines.
Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf.
How To Get Started
- Follow the procedures for requesting access to NIAID contract services.
- In addition, data packages for Chemical Synthesis should address the following items:
- Synthetic schemes used in the past to make product, including representative yields for each step
- Potential sources and pricing of unusual/unique reagents
- Outline of how synthesized material will be used (planned studies and quantities needed)