Leveraging sophisticated technologies and equipment, as well as accomplishing the most strict Quality features, this brand new unit will be involved in scale-up, tech-transfer and GMP manufacturing of niche APIs including New Chemical Entities for clinical trials.
This new unit, still under construction, takes shape in line with the project’s plan. The work in progress will continue throughout the whole 2022 aiming to put the new unit under operations by the beginning of 2023.
In a nuthsell:
- Brand New CMC building
- Custom synthesis, contract manufacturing and captive specialties development
- Small molecule modality
- Dedicated QC laboratory for IPC controls
The Clinical API Plant will provide additional GMP small-scale capacity to the 4 production lines already available at the Concorezzo Site for multi-scale production on a batch size from 100 g up to 600 Kg per batch.
Ranging a batch scale from 3 kg to 10 Kg and integrated with a dedicated laboratory for in-process controls the unit will be efficiently optimised to run synthesis, drying and finishing processes in full compliance with the international guidelines on the investigational and new drug applications.
The completion of the new Clinical API Plant, which is foreseen by the end of 2022, is an important milestone to strenghten Icrom position in the CDMO segment and will constitue the baseline to scale-up the pipeline of current developments as well to stimulate new business development strategies.
This new establishment will furthermore permit to broaden the Icrom’s CDMO service proposal improving efficiency and management of complex process industrialisation for benefit of our trusted customers and partners.