Almac supports ATMP launches with expanded European facility

The CDMO has expanded its ultra-low temperature commercial packaging, labelling and distribution solutions facility in Ireland

The company's bespoke Just-in-Time labelling, packaging and serialisation at ultra-low temperatures (-20 °C to -80 °C) has been enhanced to meet the specific requirements of both the client and the product. 

Given the nature of ATMPs, it is imperative Qualified Person (QP) release does not become a bottleneck point. Therefore, the company's expansion also includes a bespoke end-to-end consultancy service with a dedicated team of fully qualified and licenced QPs to provide advice on every aspect of ATMP launch. 

The CDMO, which is part of the Almac Group and was one of the first European CDMOs to support gene therapy product launches, says its expanded solutions enable processing and QP release of tailored treatment in as little as 20 hours. 

Almac's Centre of Excellence, located in Ireland, offers an expansive storage facility with specialist suites and freezer capacity to enable inventory stock of crucial product supply ready for rapid distribution when required. 

Mark English, VP Packaging & Logistics for Almac Pharma Services said: "We are cognisant that we implement robust and timely processes, underpinned by Quality Risk Management and designed to protect the integrity of the product whilst ensuring it gets to the patient on time." 

Almac says it currently provides solutions for more than 30% of EU approved/pre-registration ATMPs, having processed and QP released in excess of 600 batches to date.