The clinical phases play a key role in the development of an innovative drug, when the Pharma Sponsor is facing for the first time the operational challenges outside the walls of the R&D Laboratory.
The design of a novel synthetic process to manufacture a drug substance implies critical scale-up, downstream and safety studies in order to set a future successful technology transfer to the industrial level.
The scale-up step represents the test ground for the industrial feasibility, where the manufacturing critical parameters are identified and trouble-shooted through operational innovation and flexibility and implementation of more efficient technological approaches.
Bridging successfully a chemical process from a lab. to the industrial GMP environment is paramount important to maximize timing, costs and resources along the entire project development pathway of a new drug.
A new Clinical scale API Plant is under construction at the Italian Icrom Site based in Concorezzo (MB) and scheduled to be under operations by the end of 2022.
A state-of-the-art unit equipped with 3 Hastelloy reactors (100 L, 200L, 400L), 3 stainless-steel reactors (100L, 200L, 400L), Hastelloy filter drier, centrifuge and a static drier.
“We at Icrom strongly believe that the passion we put in our job, the high level of expertise and efficiency we reached in tailoring projects upon customers’ needs can make the difference when the goal is to support a segment so important for public health as the Pharmaceutical Sector is. The establishment of this new clinical plant will be an important milestone to enhance our growth as trusted CDMO for the development of complex and hi-tech APIs.”
