Almac Pharma Services, a provider of pharmaceutical development, manufacturing and commercial services, has expanded its state-of-the-art ultra-low temperature commercial packaging, labelling and distribution solutions to support the launch of advanced therapy medicinal products (ATMPs) from its European Center of Excellence.

The contract development and manufacturing organization (CDMO) says it was one of the first European CDMOs to support gene therapy product launches and currently provides solutions for over 30% of EU approved/pre-registration ATMPs having processed and QP released over 600 batches to date. The specialist team at Almac offers its global clients’ expert knowledge, deep understanding and partnerships enabling the processing and release of tailored treatment in as little as 20 hours.

Almac’s bespoke solutions of just-in-time labelling, packaging and serialization at ultra-low temperatures (-20°C to -80°C) has been enhanced to offer clients a tailored experience ensuring every step of the complex process is adjusted to meet the specific requirements of both the client and the valuable product. In addition, a dedicated team of qualified and licensed QPs is on hand to provide expert advice on every aspect of ATMP launch offering a bespoke end-to-end consultancy service.

“As a result of the nature of these therapies, QP release of ATMPs requires an advanced level of knowledge, training and certification to ensure they understand the biological processes and the variability this brings,” said Robert Smith, fellow of the Royal Pharmaceutical Society of Great Britain and consultant QP to Almac Pharma Services. “It is imperative, therefore, to partner with an experienced CDMO to facilitate and expedite this crucial stage and have confidence that product will be delivered to the patient as quickly as possible.”

Almac’s track record and expertise in temperature-controlled logistics combined with its long-established relationships with reputable, experienced and trusted global supply chain providers offers clients a comprehensive end-to-end service guaranteeing expedited delivery direct to patient. The use of innovative shippers, temperature monitors and digital platforms, which enables real-time visibility into product and shipper conditions, as well as location of the shipment, ensures product will not be compromised during transit.

The dedicated Center of Excellence is located in Europe and 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.

The market for ATMPs is forecast to expand through the foreseeable future. Some industry analysists predict as much as 20% year-on-year growth through 2025 . 

Mark English, vice president of packaging and logistics, Almac Pharma Services, said, “These products are high value and, in some cases, lifesaving medication. The specialist handling, packaging, delivery, and administration of ATMPs is highly complex and time sensitive. Often, patients require treatment within days of diagnosis and therefore any delay or product degradation during any stage of processing or delivery could have devastating consequences for their health.

“Through our work with a variety of ATMPs, we understand that each product is unique in its requirements to guarantee its integrity throughout the entire process.  Through our deep understanding, experience and tailored offering, we work in close partnership with our clients to identify and agree the most appropriate methods to meet their needs.”