Supporting International CAR-T Cell Therapy Study Amid Geopolitical Challenges

Introduction

Clinical trials for cutting-edge therapies require precise planning and execution, particularly when managing the transportation and storage of specialised products.

Oximio was recently approached by a biotech company which was in the process of developing a revolutionary CAR-T cell therapy. The company required comprehensive supply chain solutions for an international clinical study, which would span multiple countries, including Ukraine, Georgia, Türkiye, and Israel.

CAR-T Cell Therapy

Chimeric Antigen Receptor (CAR) T-cell therapy is an advanced form of cancer treatment that uses a patient’s own immune system to target and destroy cancer cells. This therapy involves a series of steps where a patient’s T cells, a type of immune cell, are collected from their blood. These cells are then genetically modified in a laboratory to include a chimeric antigen receptor (CAR), which enables them to better recognise and attack cancer cells. Once the modified
T-cells are grown and multiplied, they are infused back into the patient’s body, where they work to target and eliminate cancer cells.

This treatment is particularly useful for certain blood cancers, including leukaemia, lymphoma, and multiple myeloma, and is often considered when other treatments have failed. The key distinguishing factor of CAR T-cell therapy is its personalised approach, as each treatment is specifically tailored to the individual patient. By modifying a patient’s own T-cells, the therapy is able to enhance their immune response against cancer more effectively than traditional treatments.

Challenge

The complexity of the project was multifaceted. CAR-T cell therapy, requires highly specialised handling, including transportation and storage in liquid nitrogen (LN2) to maintain its efficacy. Furthermore, the geopolitical situation in some of the involved regions posed additional risks to the transportation and delivery schedules. The main challenge was to plan and implement safe, timely, and compliant logistics solutions while managing the storage of the product under stringent temperature-controlled conditions.

Solution

Our team began by assessing the situation and were tasked with creating a secure and flexible supply chain plan. Due to the geopolitical risks in some of the countries involved, the meticulous planning of all routes was essential, with contingencies in place in the event of any unexpected disruptions. To substantiate our approach and build confidence with the client, we conducted two successful mock shipments to Ukraine. These mock deliveries helped us confirm the routes and procedures, providing invaluable insights into potential challenges.

At the same time, we addressed the product’s storage requirements. As CAR-T cells need to be stored in liquid nitrogen (LN2), we had to ensure that specialised storage facilities were set up and validated to meet the highest standards over the course of three months. We worked diligently to adhere to regulatory requirements and ensure that necessary validations were completed to meet the product’s integrity.

Outcome

Approval from the Ministry of Health (MOH) was subsequently received and we successfully delivered the first batch of CAR-T cell therapy to Ukraine, distributing the product to medical sites within the country. The successful trial operation paved the way for roll-out to the other required sites in Georgia, Türkiye, and Israel. Our careful planning, rigorous testing, and close collaboration with the biotech company resulted in the successful and compliant delivery of a critical product that could potentially change the lives of many patients.

Conclusion

This case exemplifies our expertise in providing customised, reliable supply chain solutions for clinical trials, particularly in complex scenarios. By addressing both the logistical challenges and regulatory requirements, we were able to deliver CAR-T cell therapy to key sites in multiple countries, despite the challenging geopolitical landscape. Our careful approach not only ensured the safe delivery of the product but also reinforced our commitment to supporting innovations that can advance medical treatment and improve patient outcomes worldwide.

Global Supply Chain Solutions

Oximio has been at the forefront of delivering supply chain solutions for clinical trials for over 20 years.  If you are planning a clinical trial, why not contact us and find out how we can support your research.