An international pharmaceutical company engaged in a Phase II, multicenter trial for pediatric patients with Leukemia reached out to Marken for expertise with sensitive, cryogenic shipments.
With less than 100 participants, the study required T cells (apheresis material) to be shipped from patients to manufacturing sites at 2-8 ºC within 28 hours. Over the course of several weeks, the T cells are then modified for each patient through genetic engineering (also known as Advanced Therapy Medicinal Products, or ATMP).
The modified T cells are manufactured using cryopreserved leukapheresis which offers treatment to patients in over 20 sites across four continents. The treatment must be sent from U.S. manufacturing sites back to investigator sites using LN2 conditions (shipped and stored at -80ºC). Upon arriving at the investigator site, the genetically engineered T cells – now reactive to the cancer – are administered to the patient. To gauge the success of the treatment, biological samples were taken and tested from each patient and sent to laboratories for analysis.
Adding to the complexity, cryogenic shippers require one week of validation time to ship from the US to Europe. This was insufficient time to reach the investigator sites in Europe and back. In addition, cryogenic shipper rental companies are regional, not global, and generally do not operate 24/7.
As an experienced supply chain solutions provider for this type of treatment, Marken quickly mobilized a team of experts to begin the complex logistics process, beginning with arrangements for a steady supply of cryogenic shippers.
Understanding the urgency and specialized handling needed, Marken sourced various cryogenic shipper rental facilities around the world and coordinated the transfer of ATMP and apheresis materials within the designated timelines to the global sites.
- Procuring ready-to-use cryogenic shippers and delivering them to the manufacturing site
- Establishing a chain of custody by using real time tracking and tracing technologies
- Transferring modified cells (ATMP) into specialized cryogenic shippers
- Importing materials into the EU and managing the QP-release process for European countries
- Working with the European transit site to obtain correct licensure, securing the supply chain
- Transferring ATMP into a replacement cryogenic shipper (validated for 7 days only) and shipping to investigator sites
- Ensuring the safe transportation of shipments during the holidays via Marken’s Global Control Center (GCC)
It’s critical to your supply chain process to select an experienced provider who is able to collaborate early on in the process to review potential risk points, establish contingency plans, and safely deliver specialized therapies to sites and patients around the world. Contingency plans which take into consideration all local and country regulations and Ministry of Health guidelines for each region where the product will be shipped. Marken’s 24/7/365 resources guaranteed holiday coverage with complete contingency plans in place following a standard risk assessment.
Marken analyzed the necessary requirements to coordinate a QP release and corresponded with all related parties to achieve the goal.
Ensuring that constant communication takes place between the sponsor, vendors and sites is a priority for Marken for every client, every time.
As a result of Marken’s diligence and ability to deliver on time and in spec, the therapy received approval from the FDA and can now potentially bring positive results to more patients
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