Small-scale Irish plant gains cGMP status
Helsinn Chemicals Ireland (HCI) has opened a small sale cGMP manufacturing plant at its Dublin site.
Helsinn Chemicals Ireland (HCI) has opened a small sale cGMP manufacturing plant at its Dublin site.
The new GMP Pilot Plant will complement the existing Helsinn Chemical Operations capabilities by providing the additional ability to run small-scale processes (0.5 - 2kg) under full cGMP, which is particularly relevant for the production of small clinical and/or registration batches.
The site process implementation and quality units will support the small scale manufacturing plant. The GMP Pilot Plant consists glass reactor trains, glass filter-dryer unit and vacuum drier.
The typical operating ranges for the reactors are -20 to 140°C, and full vacuum is up to maximum pressure of 0.5 bar with the option to upgrade to higher pressures for catalytic hydrogenations.
Wet processing is carried out in a reactor room while dry processing is performed in a separate finishing area. The plant is separated from the main production plant and can only be accessed via a dedicated lobby. The whole area is designed to full cGMP and is supplied with dedicated utilities.
Full flexibility has been considered in order to be able to introduce additional technologies in the future, for example column chromatography for purifications or chiral resolutions.
With this addition, Helsinn Chemical Operations is capable of providing clinical batches of classical API ranging from 0.5kgs up to 1,000 kgs thus fulfilling the needs of all clinical phases. Commercial production is also starting from kgs per year up to multi-tens of tons on both sites, Irish and Swiss.
