API manufacturing plant expansion
Finland-based pharmaceutical company Fermion is expanding its facility in Hanko, Finland, to increase its manufacturing and commercial production capabilities.
Construction of the facility began in 2016 and is scheduled for completion in the second quarter of 2018. The expansion is expected to support the production of active pharmaceutical ingredients (APIs) and highly potent APIs (HPAPIs) to meet increasing global demand.
With a total cost of $34m, this expansion represents the company’s largest investment since 1970.
The company’s aim is for the facility to meet the necessary regulatory requirements and support both its current and new business.
The expansion includes the construction of a state-of-the-art five-storey facility that will add 6,000m² (64,583ft²) of manufacturing space, increasing production capacity by 50%.
A topping-out ceremony was held at the plant in February 2017, with the new building’s main structure reaching rooftop height later that year.
The facility will produce high-quality and reliable API and HAPI products. It is expected to produce 100t of HPAPIs a year, increasing the facility’s total API production to more than 400t a year.
Fermion’s investment will ensure the supply of APIs for its parent company Orion’s current proprietary drugs and pipeline products.
The facility will contain 76m³ of reactor space installed with highly automated systems, controlled material flow, isolators and smart infrastructure.
A reactor space of around 25m³ will be dedicated to OEB5 compounds that require a contaminant level of 0.1µg/m³. The remaining space will be equipped for compounds that require a contaminant level of 1-10µg/m³.
The fully equipped existing facility consists of three production units with total reactor capacities of 240m³, reactors ranging from 1,000l to 6,300l in capacity, fully automated API production, and a separate micronisation area.
It will also feature dedicated areas for the large-scale manufacture of class IV narcotics and immuno-suppressants, a 500l Buss Loop reactor or hydrogenations up to 80bar, on-site incinerators of volatile organic compound (VOC) gases, and a biological waste water treatment facility.
The facility is compliant with environment, health and safety (EHS) regulations, with features such as a solvent recycling capacity of around 8,000t and frequent monitoring of emissions and effluents in co-operation with local and national authorities.
A wholly owned subsidiary of Orion Corporation, Fermion provides APIs for generic, speciality and branded pharmaceutical companies. It also offers fully integrated contract development and manufacturing services from Phase I to commercial-scale production.
Based in Finland, the company operates a research and development (R&D) facility and two manufacturing sites in the country.
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