11.05.13
Almac has completed a $2 million investment program, doubling its global API and drug product stability storage capacity. Almac’s new storage capacity at both its European headquarters in Craigavon, UK, and its U.S. 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. All conditions are ICH compliant, continually monitored, and supported with back-up systems ensuring a totally secure and controlled environment, according to the company.
Within its Analytical Services unit, ICH method development, validation, dissolution and release testing are also offered, allowing physical and chemical stability studies to be conducted on both API and a range of drug products, including DEA controlled substances.
Rick Dyer, vice president of Quality Operations, said, “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, said, “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.”
Within its Analytical Services unit, ICH method development, validation, dissolution and release testing are also offered, allowing physical and chemical stability studies to be conducted on both API and a range of drug products, including DEA controlled substances.
Rick Dyer, vice president of Quality Operations, said, “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, said, “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.”