Will start commissioning laboratory projects in 2012
Helsinn Advanced Synthesis (HAS), a division of the Helsinn Group of Switzerland, is building a new CHF20m (€15.4m) cytotoxic plant in Biasca. The engineering designs have already been drawn up as space was allocated for this expansion when the HAS facility was originally built in 2000. Approval for the extension was given in January this year.
Paolo Guainazzi, HAS’ general manager, says Helsinn’s expertise in highly potent compounds means that moving into the cytotoxic market will be a smooth transition and the firm will be able to begin commissioning laboratory projects in the first quarter of 2012.
The laboratory will include dedicated areas for r&d and QC and a small-scale GMP area will be available for the production of reduced quantities of cytotoxic APIs for clinical and registration purposes (grams to hundreds of grams). The layout, personnel, and material flow for the lab and production area will be completely independent of the existing API production plant.
The cytotoxic plant will have two different production areas, each processing one product at a time. The first will have three reactor units: a 250L S.S. glass-lined reactor; a 250L Hastelloy C2000 reactor; and a 400L Hastelloy C2000 Reactor. The section will also include a 0.125m3 Hastelloy C2000 filter dryer within a glove box. This area will be able to produce 10kg batches.
The production areas will each have reactors and a filter dryer and will be able to produce 10kg and 20kg batches, respectively
The second production area will also have three reactor units: a 630L S.S. glass-lined reactor; a 630L Hastelloy C2000 reactor; an 800L Hastelloy C2000 reactor; and a 0.25m3 Hastelloy C2000 filter dryer within a glove box.
This area will be able to produce 20kg batches.
The operating conditions in the production area will range from –80°C to +160°C with full vacuum up to +6 bars for pressure.
Helsinn Advanced Synthesis has been manufacturing Category 3 molecules (OELs ranging from 30ng/m3 to 10μg/m3) for more than 10 years in the existing highly potent facility. The new cytotoxic plant will be able to handle Category 4 molecules (OELs less than 30ng/m3).