Almac Group Announces Expansion of Pharmaceutical Development Facilities
Published: Oct 20, 2011
With an initial investment of £4.5million, phase one of the expansion will provide a state-of-the-art, non-GMP formulation development facility for the development and scale-up of solid oral dose drug products using a broad range of technologies.
The new formulation development suites will complement Almac’s existing pharmaceutical development facilities and will include high levels of control over environmental conditions as well as extending current capabilities in processing high-potent compounds with OEL’s as low as 0.03µg/m3.
The current GMP development facilities focus on drug products up to pilot scale & registration, whereas, the new facility will operate at lab-scale, with batch sizes for most technologies typically expected to be less than 15 kg scale.
John McQuaid, VP of Technical Operations explains “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 studies for candidates in late stage development.”
Phase two of the project will involve a significant expansion of GMP analytical support capabilities with the construction of 2 additional QC laboratories within the new facility.
“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. Recruitment of experienced formulation and analytical development staff has already commenced in support of this exciting expansion” stated McQuaid.
Phase one of the expansion is due for completion mid 2012 with Phase two of the expansion and configuration of dedicated analytical labs completing towards the end of 2012.
For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 41C18) and AAPS (Booth 2837) conferences.
The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS? technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has now moved into its new North American Headquarters located in Souderton PA.