Almac unveils new Cryogenic Service Solution for advanced therapy trials

Investments in next generation cold chain solutions at the company’s Durham facility exceed $4m

Durham, North Carolina – 4 October 2022 – Almac Clinical Services, a member of The Almac Group, the global contract development and manufacturing organization, today announces a new state-of-the-art Cryogenic Service Solution within its Durham, North Carolina campus to support cell and gene therapies.

This latest investment from Almac adds to the company’s overall $4m investment to date in innovative cold chain technology in North Carolina. The Cryogenic Service Solution ensures an unbroken chain of custody from product line to patient, for sponsors of advanced therapy trials. 

The fully contained GMP suite features sophisticated processing rooms to safely handle, package, and label advanced therapies under cryogenic conditions. Segregated processing rooms with cutting edge cryogenic freezers, capable of storing 40,000+ vials in -150°C to -196°C temperature ranges, will enable biologic materials to be preserved in liquid nitrogen vapor, while offering 100% redundancy to maximize product integrity.

A new cryogenic shipping service completes the offering, using specialist vapor and validated shippers with cryogenic boxes; dispatching products to customer destinations and guaranteeing product integrity throughout transit.

This announcement follows Almac’s unveil of an innovative combination Ultra-Low freezer and cold processing suite also at its North Carolina campus, accommodating 960 ft3 of Ultra-Low temperature sensitive materials.

Donna Christopher, Global Vice President of Operations for Almac Clinical Services explains:

“The continued growth of the cell and gene therapy market represents an incredibly exciting chapter in modern drug development. This growth brings with it significant opportunity across a broad range of therapeutic areas, from oncology to autoimmune diseases and diabetes. Yet the opportunity is not without challenge. The complexity of operating global clinical trial supply chains involving incredibly volatile, high value IMP has the potential to drastically restrict study success.

“Despite the unprecedented disruption caused by the pandemic in recent years, Almac’s mission to invest in the continued advancement of human health has remained steadfast. Almac’s new Cryogenic Service Solution is testament to this and our commitment to customers and the patients they serve, both today and tomorrow. With the complete chain of custody, the Cryogenic Service Solution provides advanced therapy sponsors precise cryogenic conditions at every touchpoint; upholding product integrity and a truly integrated, optimized and patient-centric clinical supply chain experience.”

Almac Clinical Services continues to invest in capabilities, capacity and technology to deliver an innovative clinical supply solution for Advanced Therapy Investigational Medicinal Products. The range of exciting, advanced therapies in clinical development continues to increase across Almac’s global sites in the US, EU and APAC, demanding unique expertise and an end-to-end view of the complete clinical supply chain.

For more information about Almac’s Cryogenic Service Solution, please visit here.

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About Almac Clinical Services

The most comprehensive Global Clinical Supply Chain Solution in the marketplace

Almac Clinical Services has over 30 years’ experience deploying clinical supply chain expertise and a full suite of end-to-end clinical solutions to over 600 Pharmaceutical and Biotech companies worldwide. 

Guided by extensive clinical supply experience and expertise, Almac Clinical Services are recognized as one of the leading, multi-faceted, global solution providers within the niche and complex market of clinical trial supply.

About Almac Group

A unique culture delivering exceptional solutions

The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organization which has grown organically over the past five decades now employing over 6,000 highly skilled personnel across 18 facilities including Europe, the US and Asia.

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