Almac Clinical Services, a member of the Almac Group, introduced a new state-of-the-art Cryogenic Service Solution at its Durham, NC campus to support cell and gene therapies.

  

This latest investment from the company’s overall $4million investment to date in cold chain technology in NC includes the Cryogenic Service Solution to ensure 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 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 maximize product integrity. 

 

The company also offers a new cryogenic shipping service using specialist vapor and validated shippers with cryogenic boxes; dispatching products to customer destinations and guaranteeing product integrity throughout transit.

 

This follows Almac’s new innovative combination Ultra-Low freezer and cold processing suite at its NC 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.

 

“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.”