Around the world in 2 days-ensure safe delivery of personalized therapies

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The session will dig deep into the logistical challenges of delivering personalized therapies such as in Cell Therapies and Radioligand Application. For these innovative technologies, Shelf Life and Rapid Logistics on a high level of organizational excellence directly drive feasibility and market access. Our logistics experts will engage directly with opinion leaders and innovators in these fields to discuss best practices in GDP-compliant logistics, cross-border scalability and supply chain effiency. Join us for a healthy bite of knowledge to gain knowledge on how to secure efficient supply chains for one some of the hottest fields in therapy development.

Personalized therapies need special logistics to assure that the therapy is reaching the patient in time and in good quality. Especially two therapy types have the challenge of very short timelines and the need of global distribution.

Autologous cell therapies are made directly from patient derived cells and often the apheresis material and the therapy after manufacturing are shipped in ambient or refrigerated temperatures to achieve the highest vability of cells. Due to the limited number of these specialized manufacturing sites global distribution is required for very limited shelf lives of two to three days. Even when the cells and therapies are frozen in liquid nitrogen very short transport times are required to bring the life saving therapy as soon as possible to the patient.

The other situation is with radiopharma products which include a radioisotope with a half-life of 3 to 10 days coupled to a biopharmaceutical. The shelf life is a combination of the half-life and the shelf-life of the pahramceutical and in most cases for radio-ligand therapies only two days are remaining for transport between the manufacturing site and the nuclear pharmacy of the treatment center where the patient will get the radiotherapy.

Sponsors and pahrma companies need to include these requirements and logistics limitations in their development plans. Often a decision in early development is leading to enormous problems later during clinical and commercial distribution up to preventing that a promising therapy is ever reaching the patient.
Transport providers need careful planning including lane mapping, shipping technology, tracking tools and contingeny plans to enable these shipments in time.