Prostate cancer is one of the most common types of cancer in men. In recent years, immunotherapy has emerged as a promising treatment to potentially change the way this disease is treated and the research to find a cure.
A specialty pharmaceutical company investigating prostate cancer treatments launched a Phase III, randomized, double blind clinical trial utilizing Active Cellular Immunotherapy (ACI). Patients enrolled in the trial from around the world, including a number of sites across the United States and Europe. Over the course of several years, more than 1,000 patients were recruited into the study.
The autologous trial required that once white blood cells are harvested from the patient (leukapheresis), they are transported from multiple medical centers around the world to one key manufacturing site to be turned into Investigational Medicinal Product (IMP). If transit times exceeded 24 hours during this process, cells would deteriorate, and ultimately result in the exclusion of patients from the program.
Once at the manufacturing site, monocytes (a type of white blood cell) are isolated, frozen and ready for delivery to a physician’s office for administration in the form of a vaccination. The manufacturing process takes several weeks and involves numerous resources to complete.
Marken performed a lane-by-lane risk assessment and logistics plan to ensure optimal delivery times to both the manufacturing site and selected medical centers. A chain of custody document was created in collaboration with the client to accompany each consignment and to be completed by the shipper, courier and the consignee.
The therapy and protocol require that the supply chain maintain specific temperatures and a strict timeline for IMP efficacy to ensure that the patient can remain in the trial.
As an industry expert in sensitive and complex supply chain solutions, Marken organized the highly specialized transportation of the white blood cells from the medical centers. As part of this service, Marken provided conditioned Credo boxes for 2 – 8 °C shipping. The transport temperature range was changed mid-study by the sponsor and Marken was prepared with 15 – 25°C Credo boxes for shipping. Additionally, to preserve the integrity of the clinical material as they travelled to the single European manufacturing site, Marken ensured that door to door transit times were completed within 24 hours or less.
Marken then shipped the ACI in cryogenic shippers from the manufacturer on to a separate, central storage facility. Upon the client’s instructions, Marken delivered the active cellular immunotherapies in cryogenic shippers to physicians to administer to patients as part of the study treatment
To preserve the efficacy of each shipment, achieve required transit times and to safeguard against any excursions:
- Collections were scheduled at optimal times to ensure immediate processing could take place at the manufacturing facility
- Integration between Marken’s systems and selected vendors was seamless
- End-to-end tracking and other IT visibility options through the last mile were provided to the client throughout the trial
- Patient safety, shipment efficacy, and enrollment status remained a priority
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