We transferred an existing product from a non-GMP environment to cGMP conditions for a European customer’s new pharmaceutical application in the range of >10 MT per year.
We redesigned and rescaled most steps in the synthesis to fit our equipment and HSE requirements. Challenges were a short project lead time and special HSE requirements, such as those stemming from the large scale use of isocyanate and hydrazine. Adequate measures against cross contamination and operator exposure also demanded special attention.
The customer was particularly satisfied with the close cooperation by people from both sides with chemical, technical, analytical and regulatory expertise. Besides consistently delivering product on-time, within specification, we helped the customer by optimizing certain steps of the process, analytical procedures and by validating new reprocessing opportunities.