ATMP Logistics

The distribution and transport of medicines require meticulous attention to detail at every stage of the logistics chain to ensure continuous high quality of the products. Flanders has a world-renowned pharmaceutical sector with extensive knowledge and experience in logistics for transporting medicines.

However, this is not yet the case for Advanced Therapy Medicinal Products (ATMP), or cell therapy, gene therapy and products based on tissue engineering. These types of medicines require specialized logistics, in which real-time monitoring of temperature, location and security are crucial, e.g. via the Control Tower concept.

Goal

In this growing market of both short-haul road distribution and air freight, VIL has worked with the participating companies to develop improved solutions for the logistics of clinical trials and has translated them into a clear short-term guide.

In parallel, we will develop a reliable, economically feasible, and scalable medium-term logistics model to address packaging, refrigeration, and traceability challenges.

Results

• ATMP drugs are patient specific and extra sensitive in terms of temperature and shelf life.
• The project shows that ATMP requires specialized supply chains that must be both scalable and flexible to meet ATMP-related challenges. It is particularly important to set up the logistics chain to perfection for this purpose.
• Current logistics chains are focused on known pharmaceutical products that are transported regularly and in large volumes. Completely the opposite of what is needed for ATMP. Here it is mainly irregular shipments, with low volumes shipped by small biotech companies or academics.
• ATMP is relatively new, but in full development. To cope with the expected growth of this type of therapy, VIL has established practical guidelines.
• VIL recommends involving supply chain experts in the early stages of development. That way, important ATMP-related concerns such as temperature and time sensitivity can be taken into account right away. Real-time and complete supply chain visibility is a necessity.
• In addition, everyone involved in logistics must be adequately trained so that products can be handled correctly.
• VIL also further advocates the development of a specific ATMP label. This label should make it clear, without ‘prior knowledge’ that important and sensitive products are handled and transported.
• During this project, the ATMP Excellence Center was established that will further deepen and disseminate knowledge about ATMP supply chains to the industry.