Almac Increases Global Stability Storage Capacity

Almac has completed a $2 million investment programme that 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 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 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 APIs and a diverse range of drug products, including DEA controlled substances.

Rick Dyer, VP Quality Operations, commented: “With more than 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 drug substance and drug product; from non-GMP compliance to pivotal registration/commercial studies.