Helsinn expands high-potency plant with cytotoxics suite
pharmafile | March 8, 2011 | News story | Manufacturing and Production | APIs, CMOs, GMP, Helsinn, Helsinn Advanced Synthesis, Swiss pharma contract manufacturing, contract manufacturing, high-potency APIs
Helsinn is on track to complete construction of a new manufacturing plant for cytotoxic active pharmaceutical ingredients in Biasca, Switzerland, and expects to start fulfilling small-scale production orders early next year.
The new plant, operated by subsidiary Helsinn Advanced Synthesis, is being built at a cost of around 20 million Swiss francs ($22 million) and expands the firm’s existing operations at Biasca, which focus on high-potency APIs (HPAPIs).
That expertise means that moving into the cytotoxic market should be a “smooth transition”, according to Paolo Guainazzi, HAS’ general manager. “We will be able to begin commissioning laboratory projects in the first quarter of 2012,” he said.
HAS’ existing highly-potent facility, has been manufacturing Category III molecules with an occupational exposure limit (OEL) of 30ng/m3 to 10mcg/m3 for around 10 years. With the new facility Helsinn will be able to handle Category IV molecules with OEL limits of less than 30ng/m3.
The new plant will have areas assigned to R&D and quality control, as well as a small-scale production unit operating to Good Manufacturing Practice (GMP) standards within the lab unit. This will be able to make cytotoxic APIs in quantities ranging from a few grams to a few hundred grams.
A larger manufacturing plant will generally have the capacity to make batches up to around 20 kilos, or several hundred kilos a year, split across two production areas.
Market research firm GBI Research predicts that the global high-potency API market – including cytotoxics – will grow at a compound annual rate of 8.4% between 2009 and 2015, outstripping growth in other API categories.
HPAPIs are increasingly prevalent in pharmaceutical pipelines and this has been driving demand for manufacturing capacity, both at the small and large-scale.
For contract manufacturers, offering HPAPI production has proved a lucrative strategy as there are high barriers to entry in terms of developing containment, contamination prevention and operator safety expertise.
CMOs in the USA and Europe have increasingly been moving into specialised areas such as HPAPIs, because to date there has been less competition from emerging API markets such as Asia and eastern Europe.
Phil Taylor
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