The Northwestern University site (NU) will transfer the synthetic chemistry technology developed in the investigator laboratory for the GMP compatible production of the drug substance (active pharmaceutical ingredient =API) to the CMO. NU will assist with GMP process development (including advice and trouble shooting of location specific technical issues with the synthetic scheme and intermediate/product work up). NU will advise and assist with the tests of stability and analytical chemistry of the drug substance and drug product. NU will advise, monitor and assist with the multikilogram scale GMP production of the drug substance, development of GMP formulation scheme, and analysis of GMP drug product. NU will assist with and advise on the preparation of reports published by the regulatory CRO for FDA submission toward the final goal of IND issuance.
|Effective start/end date||9/1/15 → 4/30/19|
- University of Kentucky (3200001251-16-257//5U01AG050636-03)
- National Institute on Aging (3200001251-16-257//5U01AG050636-03)