Helsinn, the Swiss pharmaceuticals and APIs producer, is to expand the high potency API (HPAI) capabilities of its main site in Biasca and sell one of its Irish manufacturing plants. This is described as part of a plan to create “a competitive manufacturing organization focused on highly potent compounds, with strong R&D and production capabilities”.

The company will invest an unspecified amount, on top of about €5 million already spent in recent years, to raise quality, safety and manufacturing standards to expand at the Helsinn Advanced Synthesis site at Biasca. The facility had recently gained ISO 14001 and OHSAS 18001 certification for the development and manufacture of APIs after an inspection by SGS International in May.

Helsinn Advances Synthesis, which sits alongside the main Helsinn Chemicals Switzerland plant, employs 23 and has total production capacity of 24,000 liters. Within this, there are small and large-scale high potency manufacturing plants, both operating at between -75ºC and +200ºC.

The former has two 10 litre reactors, one glass-lined and one in hastelloy, producing 50-300 g/batch at pressures of up to 10 bar, with isolation in a 50-litre plate dryer oven. The latter has two glass-lined and one stainless steel reactor, with total capacity of 600 litres, operates at up to 50 bar, usually producing batches of 1-7 kg, with isolation in a 50 litre hastelloy pressure filter dryer.

Helsinn has been considering expanding in this rapidly growing area for some time, either via the construction of a mirror-image second HPAI plant or investing in a large-scale HPAI plant for 30-300 kg batches within the same building. Further details have not been disclosed at this stage, however.

The Helsinn Chemicals Ireland (HCI) plant in Mulhuddart on the outskirts of Dublin, which has been in operation since the early 1990s, has been sold to Milan-based Medinco CFM Group, a supplier of generic APIs. Terms were not disclosed.

Originally, HCI mainly made Nimesulide, the main company API at the time, but it has since moved in the direction of third party manufacture. Key capabilities there include the synthesis of small molecule APIs, micronising, milling, sieving and blending, scaling up and optimising processes and drug product and API testing.

The last major investment there, in 2007, was the upgrade of a pilot-scale plant to GMP by the addition of such features as a gowning area and separate finishing areas for wet and dry processes. This plugged a gap at the 1-5 kg level, allowing the site to produce APIs to GMP from 500 g to 1 tonne scales.

This means that all contract manufacturing activities have been concentrated in Switzerland. However, Helsinn retains a presence in pharmaceutical manufacturing in Ireland, where it has been based since acquiring Birex Pharmaceuticals in 1990 and hitherto employed about 210 people. Earlier this year, it spent €13 million, with assistance from the Irish Development Authority (IDA), to build a centre of excellence in R&D for oral solid dosage forms, creating ten new research jobs in the process.

Helsinn’s business model is based on licensing in early stage NCEs in niche areas, taking them through pre-clinical and clinical studies and CMC development to market approval, then selling them directly, through its own subsidiaries or through local partners. It has about 450 employees and turned over €178 million in 2008.