Helsinn Advanced Synthesis SA (HAS) has opened its largest production facility for cancer drugs to date. HAS is the production-focused subsidiary of the Lugano-based Pharma group Helsinn. It specializes in the development of quality products for cancer treatments and rare diseases.
According to a press release, active pharmaceutical ingredients (APIs), high potency active pharmaceutical ingredients (HPAPIs), high quality intermediates and anticancer compounds are to be developed and manufactured at the new production facility located in Biasca in the canton of Ticino.
HAS built its first dedicated anticancer plant back in 2012. Due to the success of this plant, HAS had been planning to expand capacities since 2016. The new production facility includes three reactor units of different sizes, a conic reactor for loading operations in a closed system, a filter dryer and a mill. In addition, there are five glove boxes to guarantee safe product handling.
The Swiss regulatory authority Swissmedic had approved the commencement of production operations in June 2020. The Biasca location will be subject to routine inspections by the FDA, which is the US regulatory authority, in addition to SwissMedic and other global regulatory authorities.
“The new facility will allow us to expand our development, analysis and manufacturing capabilities”, comments Waldo Mossi, Local General Manager for HAS, before explaining that this will be central to manufacturing and delivering new anticancer compounds to clinics and their patients.