How Cell & Gene Therapy is Disrupting the Cold Chain Model

Since the first approval of a gene therapy treatment in 2017, the market for personalised biological treatments has grown exponentially. In the UK there has been 20% year-on-year growth in cell and gene therapy trials. For this new wave of therapies, the UK has become a prominent location for research and development. This is partly due to the investment in this sector, for example, the UK government Industrial Strategy Challenge Fund has provided £70 million in funding.

The promise of personalised medicine is not to be understated. Autologous treatments are custom made and designed around an individual’s DNA, using their own cellular immune system to create treatments that have the ability to repair and replace defective or missing genes. These treatments are already proving successful in treating diseases such as immune deficiency, haemophilia and leukaemia.

Disruption to the Supply Chain Model

This new line of treatments is disrupting the traditional supply chain model. Both Autologous and Allogenic treatments require materials directly from the patient or via donors, and from then go through multiple manufacturing stages and back to the desired patient. These highly individualised treatments create an entirely new supply chain model that is more circular than linear.

Cold-Chain

Alongside the complexity of a circular model, the biological and circular nature of gene and cell therapy presents serious challenges to temperature control. For example, the biological material that is given by either the patient or donor is often shipped at a 2–8 °C range whereas most manufactured therapy needs to be transported under liquid nitrogen. Yet even these ranges are not set in stone and could vary dependent on the type of material and treatment, so logistics suppliers need to highly proficient and understand the correct temperature range for all types of biological materials.

Companies will need to use both CRT packaging and Dry Vapor shippers to package the consignment. To avoid a break in the cold-chain, logistics suppliers must regularly monitor temperature either manually or integrate technology that will automatically monitor and also control temperature levels to prevent any treatments being wasted. For example, IoT enabled temperature sensors provide real-time condition monitoring capabilities, preventing environmental risks with instant alerts to any deviations from the desired range, so the packages can be fixed before the treatments are spoiled.

Additional Stages

With Autologous treatments, it is crucial to maintain a visible supply chain and create a chain of identity to ensure the treatment reaches the correct patient. The circular concept is a lot more complex than traditional manufacturing operations, where products are produced on a mass basis and shipped from one location to another.

The diagram below demonstrates the multiple stages involved with any cell or gene therapy treatments. Logistics supplier must Integrate GPS trackers or IoT sensors to maintain visibility and track these time-critical shipments, minimising any possible delays or loss in life-saving treatments.

Alongside this, there needs to be exceptional fleet management to align the hospital timing with the manufacturers. Suppliers can use technology such as geofencing to aid their scheduling as it will send instant alerts as soon as you enter a particular location.

Time Restriction

To maintain a cell’s viability, it needs to be transported within 40–50 hours. These therapies will require prioritised shipping to ensure they reach their destination before expiration. These shipments have the same level of urgency as transporting organs for transplant. For many of these treatments, a just-in-time delivery process is required.

When it comes to international shipments, time becomes an even greater concern. Some countries have strict customs regulations and a hold-up in a customs department could be detrimental to a treatment’s viability. So, companies need to proficient in all customs documentation and having additional certifications such as Authorised Economic Operator (AEO) will allow consignments to be prioritised, ensuring swift movement through customs.

Logistics suppliers that are DG approved and currently servicing the pharmaceutical sector need to adapt their current operations to meet this challenging new market. They need to create a solution that will address the time-critical scheduling