The expansion, the latest in a number of new investments, will cost £4.5m ($7.1M) and is intended to provide the company with a state-of-the-art, non-GMP formulation development facility for the production of solid oral dose drugs.
Almac says the new formulation and development suites will serve to compliment its existing pharmaceutical development facilities, whilst offering superior levels of control over environmental conditions, and extending the company's current production capabilities in the manufacture of high-potent compounds with OELs (occupational exposure limits) as low as 0.03 micrograms.
John McQuaid, vice president of technical operations for Almac, said: “Almac's intention is to ensure that there is a seamless transition between development and GMP phases of projects in early stage clinical development.
“Additionally the scale we have chosen will support the growing area of process DoE [design of experiments] studies for candidates in late-stage development.”
Batch sizes
Once complete, the new facility will operate at lab-scale with most batch sizes expected to be under 15kg. In contrast, Almac's current GMP development facilities deal exclusively with drug products up to pilot scale and registration.
This first development phase is scheduled for completion by the middle of 2012, with a second significant phase of development – this time dealing with the expansion and configuration of dedicated analytical labs – scheduled for completion later that year.
“The new facilities will effectively double our current pharmaceutical development capacity, allowing us to meet the growing demand for our services, both from existing and new clients,” said McQuaid.
“Recruitment of experienced formulation and analytical development staff has already commenced in support of this exciting expansion.”
Almac already employs more than 3,300 people at sites in both Northern Ireland and the US. The company was recently praised by Northern Ireland's minister of enterprise, trade and investment, Arlene Foster, for helping increase the global profile of the country's life sciences sector.