The Irish manufacture of investigational medicinal products (IMP) license allows Helsinn to bring primary and secondary packaging operation in-house.
The Swiss firm’s strategy is to license early-stage new chemical entities, develop them through to market approval and then out-license them to distribution partners worldwide. Prior to today’s news the firm had relied upon third parties to package its clinical trial supplies.
Late last year Helsinn added trial scale good manufacturing practice (GMP) standard active pharmaceutical ingredient (API) manufacturing facilities at the plant, which are capable of producing batch sizes in the 0.5kg to 2kg range.
In a press statement, Helsinn COO Giorgio Calderari said that the approval is the result of considerable investment the firm has made in labeling and packaging technology since 2007.
Dr Calderari said that: “Having this authorisation expands the range of development activities we can manage within the company and can offer our partners.”
He added that the clearance will help the firm control costs and enables it to react to the last minute changes that can often occur during clinical development projects.
Helsinn has already completed the first packaging run at the Dublin site, preparing stocks of its anti-nausea drug Aloxi (palonosetron) for ongoing US trials in breast cancer.
Helsinn did not respond to in-PharmaTechnologist’s request for additional information.