Almac doubles global stability storage capacity

Published: 5-Nov-2013

Completes an investment of US$2m to increase capacity at UK and US facilities


Almac has completed a US$2m investment programme which doubles its global API and drug product stability storage capacity.

Almac’s new storage capacity at both its European headquarters in Craigavon, UK, and at its US 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 to ensure a totally secure and controlled environment.

Almac offers ICH method development, validation, dissolution and release testing within its Analytical Services unit. This capability enables physical and chemical stability studies to be conducted on APIs and a diverse range of drug products, including DEA controlled substances.

Rick Dyer, VP Quality Operations, said: 'With over 150 live stability programmes being managed at any one time, this is a welcome investment and enhancement to our facilities in both UK and US. Coupled with the recent completion of our API manufacturing facility, Almac is well placed to support the development and regulatory approval of our clients’ drug development programmes.'

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.

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