Almac Increase Global Stability Storage Capacity
November 5, 2013
Almac have completed a $2m investment program which doubles its global API and drug product stability storage capacity in line with its growth forecast.
Almac’s new storage capacity at both its European headquarters in Craigavon, UK, and at its USA headquarters in Souderton, PA enable conditions of 25°C / 60% RH, 30°C / 65% RH, 30°C / 75% RH, 40°C / 75% RH, 5°C, -20°C to be offered. All conditions are ICH compliant, continually monitored, and supported with back-up systems ensuring a totally secure and controlled environment.
Within its Analytical Services unit, ICH method development, validation, dissolution and release testing are also offered. This capability enables physical and chemical stability studies to be conducted on both API and a diverse range of drug products, including DEA controlled substances.
Rick Dyer, VP Quality Operations, commented, “With over 150 live stability programs being managed at any one time, this is a welcome investment and enhancement to our facilities in both UK and USA. Coupled with the recent completion of our API manufacturing facility, Almac are well placed to support the development and regulatory approval of our clients’ drug development programs.”
Aeri Park, Director of USA Operations, added, “The brand new stability chambers are of the highest quality standards to continue offering excellent reliability and increased efficiency for our clients looking to outsource stand alone stability studies, or in an integrated fashion, with Almac’s clinical trial supply services.”
Almac can provide stability studies from a single batch to multiple batches / packaging materials for both drug substance and drug product; from non-GMP compliance to pivotal registration / commercial studies.
Find out more about this exciting announcement and other developments by visiting Almac at AAPS, stand 4128.
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.