The new site expands the breadth of Eisai’s manufacturing operations, complementing its existing 190,000 sq ft oral solid-dose facility, to reflect the composition of its drug development pipeline.
Isolator containment technology has been installed, giving Eisai the capacity to process the highly potent compounds used in its pipeline of oncology treatments. Aseptic processing suites, laboratories and other support functions are also housed at the site.
Opening the facility will give Eisai the capacity to support the commercialisation and development of its oncology pipeline, including breast cancer therapy eribulin mesylate.
Following completion of Phase III trials this treatment has been submitted for regulatory approval in Japan, the US and the European Union. If successful, the product may become the first treatment to be manufactured at the new site.
Eisai has a longstanding interest in oncology and has increased its presence in the field through the acquisition of Morphotek and expansion of its infrastructure and North American sales and marketing efforts.
RTP presence
Eisai first established a presence in RTP in 1997 when it finished construction of an 85,000 sq ft oral solid-dose production and development facility. This was expanded in 2001 and again in 2003 to create a 190,000 sq ft operation.
The new facility complements the existing operation by expanding the capabilities Eisai has at RTP. To support these operations, and future expansion, Eisai opened a $22m central utilities building in 2008. This supplies power, steam, chilled water and compressed air to the facilities.
"Constructing this new facility at our current location has allowed for the seamless integration of our production and research and development operations", added Hajime Shimizu, Chairman and CEO of Eisai Inc.