Almac Clinical Services, a member of The Almac Group, the global contract development and manufacturing organisation, has announced 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 $4 million 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, enables biologic materials to be preserved in liquid nitrogen vapor, while offering 100% redundancy to maximise 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.
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, optimised and patient-centric clinical supply chain experience
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 said: “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.
Christopher continued: “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, optimised 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.
