Operational Milestone (OM) #1
Based on the research grade API synthesis, a scale-up manufacturing process has been developed and confirmed feasible by the successful production of a demonstration batch of the API at 600g scale with an overall yield of 70% and purity of 99.91%. Using this process, 8.8Kg of the API has been manufactured to cGMP. The GMP batch API has been fully characterized for its identity using multiple methods including nuclear magnetic resonance, mass spectrometry, high performance liquid chromatography and elemental analyses. Furthermore, the purity of the API has been assessed to be 99.89% with potential impurities and residual solvents identified and quantified. The quantity and purity of the API meet the proposed success criteria. Using the GMP grade API, we will carry out all the proposed IND-enabling studies and Phase 1 clinical trials.