Almac Pharma Services, a member of the Almac Group providing innovative pharmaceutical development, manufacture and commercial services, has expanded its state-of-the-art, Ultra-Low Temperature commercial packaging, labeling and distribution solutions to support the launch of Advanced Therapy Medicinal Products (ATMPs) from its European Centre of Excellence.
Almac Pharma Services 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 offers its global clients a wealth of expert knowledge, deep understanding, and unique partnerships enabling the processing and release of tailored treatment in as little as 20 hours.
Almac’s bespoke solutions of Just-in-Time labeling, packaging and serialization at ultra-low temperatures (-20°C to -80°C) has been enhanced to offer clients a uniquely tailored experience, ensuring every step of the highly complex process is adjusted to meet the specific requirements of both the client and the valuable product. In addition, a dedicated team of fully 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.
Robert Smith, Fellow of the Royal Pharmaceutical Society of Great Britain and Consultant QP to Almac Pharma Services noted, “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. It is imperative, therefore, to partner with an experienced CDMO – like Almac – to facilitate and expedite this crucial stage and have confidence that product will be delivered to the patient as quickly as possible.”
Almac’s proven 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. Almac’s 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 Centre 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. Indeed, some industry analysts predict as much as 20 percent year-on-year growth through 2025[1].
Mark English, VP Packaging & Logistics for Almac Pharma Services commented: “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.
“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.
“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.
“These innovative and personalized treatments rely on packaging and labeling over dry ice to help prevent temperature excursions and limit the time out of condition. As such, our specialist teams are highly trained and work with precision along each critical step of the operation.”
