API manufacturing plant expansion
Fermion is expanding the Hanko plant in Finland to help develop its manufacturing and commercial production capabilities.
Construction of the facility began in 2016 and is scheduled for completion in Q2 2018. The expansion is expected to support production of active pharmaceutical ingredients (API) and highly potent API (HPAPI) to meet increasing global demand.
With a total cost of $34m, this expansion represents the largest investment made by the company since 1970.
The company aims for the facility to meet the necessary regulatory requirements and support both its current and new business.
The expansion includes the construction of a new 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, while the main structure of the new building reached rooftop height later that year.
The new facility will produce high-quality and reliable API and HAPI products. It is expected to produce 100t of HPAPI a year, which will increase the total production of the Hanko facility to more than 400t of API a year.
Fermion’s investment will ensure the supply of API for parent company Orion’s current proprietary drugs and pipeline products.
The new facility will contain 76m³ of reactor space installed with highly automated systems, controlled material flow, isolators and smart infrastructure.
A reactor space of approximately 25m³ will be dedicated to OEB5 compounds requiring a contaminant level of 0.1µg/m³, while the remaining space will be equipped for the compounds requiring 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 approximately 8,000t and frequent monitoring of emissions and effluents in co-operation with local and national authorities.
Fermion is a wholly owned subsidiary of Orion Corporation that 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.
The company is a leading global pharmaceutical substance manufacturer, with headquarters, a research and development (R&D) facility, and two manufacturing sites located in Finland.
The company is known for its dynamic capabilities to prioritise and satisfy customer needs.
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