Helsinn expands Swiss production capabilities
Swiss company Helsinn is to expand its manufacturing facilities in Switzerland. with the addition of another production bay for APIs and a new small-scale high potency active ingredients (HPAI) plant. The new cGMP unit will consist of two 4,000-litre reactors.
Swiss company Helsinn is to expand its manufacturing facilities in Switzerland. with the addition of another production bay for APIs and a new small-scale high potency active ingredients (HPAI) plant. The new cGMP unit will consist of two 4,000-litre reactors.
For separation requirements, two filter dryers will be installed to accommodate the larger batch size range. One production train (reactor + filter dryer) will be in hastelloy for special APIs.
The HPAI plant is expected to come on stream by late 2005/early 2006 and will meet requirements for clinical phase products, where quantities of 100-500g would be sufficient. Helsinn's r&d laboratory will also add special hoods to serve this added capacity.
Extra space, however, will still remain available for a third high potency production plant for batch sizes smaller than 10kg, and this is likely to be installed during 2006, the company says.
This latest expansion is part of phase two of the construction of a new plant, Helsinn Advanced Synthesis. Phase one was initiated in 1999 and completed in 2001, consisting of the completion of two of the five API production bays and one of the two small-scale HPAI production units.
Meanwhile, in Ireland the company has recently completed a major expansion of its process implementation and quality control laboratories at the Helsinn Chemicals Ireland plant in Dublin.
The expansion will enable Helsinn Chemicals Ireland to develop and introduce additional products into the facility. The laboratory contains standard organic chemistry equipment, as well as fully supported, small-scale jacketed vessels, ideal for the beginning of the scale-up process.
Current projects in the process implementation group vary from basic process research, to technical transfer of processes, to the optimisation of crystallisation of existing processes.
Particular expertise in particle manipulation and pre-formulation has been developed and new equipment to compliment this service will be added in 2005.