Almac Boosts Global Stability Storage Capacity
Contract developer, manufacturer, and packager Almac has doubled its global API and drug product stability storage capacity, the company reports in a release.
New storage capacity at both Almac's European headquarters in Craigavon, UK, and at its USA headquarters in Souderton, PA, maintain conditions of 25°C / 60% RH, 30°C / 65% RH, 30°C / 75% RH, 40°C / 75% RH, 5°C, -20°C. All conditions are ICH compliant, continually monitored, and supported with back-up systems ensuring a totally secure and controlled environment, the company reports.
Almac provides stability studies from a single batch to multiple batches and packaging materials for both drug substance and drug product as well as from non-GMP compliance to registration and commercial studies, the company reports.
Almac's Analytical Services unit offers ICH method development, validation, dissolution, and release testing, enabling physical and chemical stability studies to be conducted on both API and a range of drug products, including DEA controlled substances, the company reports.
“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 USA," stated Rick Dyer, VP Quality Operations, in the release. "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 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.”
For more information about Almac, please visit www.almacgroup.com.