Fermion Opens New High Potency Facility Capable of Handling OEL Class V Compounds

Fermion was first inspected by the US FDA in 1979.  Since that time Fermion has maintained a strong regulatory track-record and has enjoyed uninterrupted commercial cGMP production across its product range.

With a stated focus on highly potent oncology products, Fermion has successfully developed and commercialized over 10 innovative oncology products that are currently marketed in the USA, EU and Japan.  Looking beyond oncology, Fermion also excels at the development and manufacturing of highly potent products from other classes including sedatives and respiratory products.  These types of drugs are already manufactured commercially in Fermion’s existing high potency manufacturing facility in Oulu, Finland. However, the growing prevalence of highly potent products in the marketplace made it clear that a new facility was needed that could safely handle the production of OEL Class V drugs.

Fermion’s new facility is equipped with two distinct high potency processing lines.  One line is dedicated to manufacturing anticancer products while the other is kept empty and can be adapted for use with many types of compounds.  Both of these lines each contain four x 250 l GL reactors and two pressure filter dryers, all of which are suitable for use with OEL Class V compounds. When this new facility comes on-line, Fermion will have over 10 cubic meters of additional high potency manufacturing capacity. This is made possible by an assortment of reactors ranging in volume from 70 l to 1,500 l.

The construction of this facility began in mid-2011 and the finished plant is scheduled to come on-line in March 2012.  At the time of this article, the physical structure has been completed and the electrical, HVAC, reactor and transfer hose systems have been successfully installed.  By the fall of 2012, additional improvements will allow hydrogenation reactions to be undertaken at the facility.

The new facility will be operated as a Class 100,000 unit.  It is fully automated and all maintenance work can be done from the outside. The trend of new innovative products being more potent than their predecessors leads Fermion to believe that this new facility will soon be very active.

The first products to be transferred to this facility will be Camptothecin derivatives such as Irinotecan.  Due to growing demand for these types of products and the additional space made available by the expansion, the manufacturing level of these products is expected to triple.