Almac Group’s CDMO subsidiary, Almac Pharma Services, has expanded its ultra-low temperature commercial packaging, labelling and distribution services to support the launch of Advanced Therapy Medicinal Products (ATMPs) from its European centre.
The company says it currently provides solutions for more than 30% of EU approved/pre-registration ATMPs having processed and QP released over 600 batches to date. The specialist team’s expertise enables the processing and release of tailored treatment in as little as 20 hours, Almac claims.
The company’s ultra-low temperatures (-20°C to -80°C) offering has been enhanced, aiming to ensure every step of the highly complex process is adjusted to meet a client’s specific requirements. A dedicated team of QPs is also on hand to provide advice on the product launch.
The company’s shippers, temperature monitors and digital platforms enable real-time visibility into product and shipper conditions, as well as the location of the shipment.
Robert Smith, Fellow of the Royal Pharmaceutical Society of Great Britain and Consultant QP to Almac Pharma Services said: “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.”
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.”