The Finnish API contract development and manufacturing organisation (CDMO) is expanding its API plant with additional reactor space
The Fermion facility in Hanko, Finland
Fermion, a Finnish API CDMO, is expanding its API plant with 76m3 additional reactor space by 2018. The new, fully automated facilities can process HPAPIs requiring a containment level of 0,1µg/m3. The investment totals €30m and it is the largest in the history of the company.
2018 will mark the start of a new era in Fermion’s history as its plant in the south of Finland, Hanko, starts operating new API manufacturing facilities including 76m3 of reactor space, incremental to Fermion’s current total reactor volume of 320m3. With best-in-class automated systems, controlled material flows, isolators and smart infrastructure the new facilities can process not only standard but also potent APIs. There will be a reactor space of 25m3 for OEB5 compounds (containment level down to 0,1µg/m3) and the rest of the new capacity is equipped for compounds requiring a containment level of 1-10µg/m3.
With the new, modern facilities Fermion will be prepared to meet tightening regulatory requirements and be better positioned to support both current and new business.
Aerial view of the Hanko plant in which the firm is investing €30m
Fermion’s President Arto Toivonen said: 'The expansion lifts Fermion to a new level in the global arena of API and especially HAPI manufacturing, improving Fermion’s capability to meet increasing demand. Fermion will continue to ensure high quality and delivery reliability of its products. The new unit alone will be able to produce 100 metric tons HPAPI per year increasing the total production capacity of Fermion to over 400 metric tons API/year. Fermion’s scale of HPAPI development and production will now be complete with capabilities from grams to tons.'
Fermion’s investment of €30m in Hanko is the largest in the history of the company since 1970 and also turns a new page in the history of the Finnish pharmaceutical industry.
The Hanko plant is Fermion’s largest production facility with an annual API capacity of approximately 300 metric tons. It supports the full scale of commercial API manufacturing, both generic and custom APIs. The plant consists of three operational units, two dedicated for intermediate production and the third, fully automated unit inaugurated in 2001 produces APIs. The plant is well equipped with dryers and mills for API micronisation and has a Buss loop reactor for hydrogenations as well as an on-site incinerator of VOC gases and a biological waste water treatment facility.
The expansion project already has a building permit and the planning is well underway. The actual construction will start in the summer of 2016 and the inauguration will be celebrated in Q2 2018. Times beyond 2018 may hold even more exciting news for Fermion as upon inauguration, the new facility will host empty, flexible space enabling the installation of a total of 25m3 of additional reactor space for special process technologies.