Helsinn restructures API units in Switzerland, Ireland
pharmafile | June 23, 2009 | News story | Manufacturing and Production | Helsinn
Pharmaceutical group Helsinn is planning to expand its manufacturing capabilities with a new round of investment at a production facility in Switzerland that will boost its ability to make highly-potent active pharmaceutical ingredients (APIs).
The move is part of a broader re-engineering of Helsinn's manufacturing division, which provides contract development and manufacturing of APIs and finished dosage forms to biopharmaceutical companies.
The Advanced Synthesis unit opened in 2001 and already has two isolator units for the production of high-potency compounds.
High-potency compounds are a growth area in contract manufacturing, and a number of companies have been investing in the technology required to make them as a means of insulating their businesses from the growing commoditisation of the API supply market.
Because of the relatively high cost of production European CMOs have struggled to compete with Asian manufacturers of APIs, and moving into specialised areas such as high-potency compounds and biologics – which have a higher threshold for entry – is one solution.
That trend ties in with another element of Helsinn's revamp, namely the sale of its Helsinn Chemicals Ireland Ltd. plant in Dublin, to the Italian company Medinco, which specialises in the supply of generic APIs.
The developments are the latest in a series of investments in manufacturing and R&D at Helsinn. Earlier this year the Swiss company set aside 13 million euros to build an R&D unit in Ireland for developing oral sold-dosage formulations, and it has spent around 5 million euros in recent years to upgrade quality, safety and manufacturing capabilities in Biasca.
The two Biasca units both received ISO 14001 and ISO 18001 certification following an inspection by SGS in May, confirming they meet acceptable standards for making intermediates, APIs and high-potency APIs.
Meanwhile, Helsinn has also been busy on the drug licensing arm of its business, acquiring New Jersey-based Sapphire Therapeutics in January to boost its pipeline of drug candidates and expand into the US market.
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