It’s a long way from the preliminary synthetic route in milligram scale to the GMP-compliant and validated technological process, but we are here to assist you.
First, we’ll develop the process, determine the problems and critical issues, isolate the impurities, improve the yields, and optimise the reaction conditions.
Then, we’ll upscale the process to the commercial level and study the upscale effects. Afterwards, we’ll manufacture the technical batch and develop the quality control methods.
The successful result of process development is the technical batch with API grade.