Helsinn says cytotoxics plant will be up and running in 2012
The CHF20m (€22m) facility in Biasca, Switzerland is part of the active pharmaceutical ingredient (API) manufacturer’s effort to build its potent compound production capacity in line with increasing demand.
The plant enables Helsinn to start manufacturing Category 4 cytotoxic compounds with OELs in the 30ng/m3 to 10mcg/m3 range, whereas previously it could only produce category 3 compounds.
Lugano-headquartered Helsinn started developing the Biasca site several years ago after laying initial groundwork in 2000 when it began work on its second manufacturing facility in Switzerland.
The project continued in August last year when the firm started seeking the permits required to begin manufacturing cytotoxic APIs. These were finally granted in January this year.
All this preparatory work stands to benefit the firm according to Helsinn Advanced Synthesis general manager Paolo Guainazzi who said it will cut 6 months off the original construction timeline.
Capacity
The new facility will house an laboratory with dedicated areas for R&D and quality control (QC) analysis as well as a small-scale, good manufacturing practice (GMP) standard area for the production of cytotoxic APIs for registration purposes.
The main cytotoxics production area, which will become operational later in 2012, is divided into two separate areas to allow for the simultaneous production of two different APIs in quantities of up to 20kg per batch.
In a press statement the firm said: “We are very excited to become a player in the cytotoxic market.”
