The rise of the gene and cell therapy industries has brought attention to a new set of supply chain difficulties. Companies that deal with biopharmaceuticals are faced with the challenge of transporting biological products under stringent temperature controls and time constraints, which forces them to optimize their distribution networks and supporting infrastructure. Advanced logistical solutions are necessary for these medicines to guarantee patient dosage delivery on time and at maximum efficiency.
Since cell and gene therapies provide patients with dependable treatments, they have great therapeutic utility as well as economic possibilities. However, achieving these advantages depends on supply chain participants’ capacity to successfully navigate the difficulties posed by the distribution of these resources. Companies need to look for solutions that provide the gene and cell therapy supply chain visibility and optimization because of how complex this logistical challenge is.
Cell and gene therapy distribution is a complicated system that requires close coordination and visibility from supply chain partners with specific skills. Depending on whether the treatment is allogeneic or autologous, several processes in the gene and cell therapy supply chain are involved. However, the successful delivery of medications and related care to patients is a shared objective of both supply chains.
Specialized supply chain solutions beyond those often used in the pharmaceutical sector are required for cell and gene treatments. Think about the following issues with the conveyance of cell therapy and possible solutions:
Sensitivity to Quality
Gene and cell treatments are very responsive to quality. There is a short shelf life for these tiny cell batches before their quality degrades. As a result, maintaining a cold chain and using efficient preservation techniques are essential throughout the supply chain. Cryopreservation temperatures are around minus 120 degrees Celsius (minus 184 degrees Fahrenheit), therefore reaching the ideal shipping temperatures—which are quite low—requires careful attention. Treatment facilities that are licensed to provide these treatments must also be equipped to handle, defrost, and store the pharmaceutical goods. These higher standards are too much for the infrastructure of the traditional pharmaceutical supply chain. Logistics partners must have total supply chain information in order to optimize operations and make backup plans.
Procedure Monitoring
Tight oversight of the chain of custody (COC) and chain of identity (COI) is required for gene and cell treatments. COI monitoring guarantees that pharmaceutical goods are traceable and recognizable at every stage of their journey, from extraction of raw materials to production and treatment. Stakeholders at different stages of the value chain that own pharmaceutical goods are referred to as COCs. Setting up end-to-end process tracking is essential to guaranteeing these items’ quality and safety.
Instantaneous Communication
At every point in the gene and cell therapy supply chain, but particularly during treatment administration, effective communication is essential. Authorized treatment facilities need to be set up to receive medication goods and treat patients quickly since these treatments are time-sensitive. In order to service locations with high patient densities, these treatment facilities are often positioned strategically. To get treatment, some patients may have to travel across state or international boundaries. As soon as a medication product is delivered, physicians need to get in touch with patients to get them ready for bedside therapy.
Monitoring of Quality
Quality control of the products is crucial in gene therapy supply chains. The quality of cells and medicinal products may be affected by and indicated by a number of parameters, including temperature, dwell duration, color, and sedimentation. Monitoring these components at each stage of the supply chain is essential. Stakeholders may now obtain real-time shipping data thanks to the development of smart technologies like the Internet of Things (IoT). Every cargo contains data collected by IoT sensors on cell concentration, temperature, location, pressure, and anomalies in color. Furthermore, supply chain software offers improved visibility, enabling stakeholders to keep an eye on the safety and quality of the products.
Time Restrictions
Just-in-time manufacturing is used in cell and gene treatments to increase production and delivery efficiency and minimize waste. Time is of the utmost for all parties involved to guarantee timely procedures, from cell apheresis to therapy. Stakeholders have more pressure because of the urgency of these medicines to correctly predict market demand, refrain from overproducing, and minimize any delays. For patients to get their treatments on schedule, shipments need to be accurate yet flexible.
Planning for Demand
Demand planning is a challenging task since cell and gene treatments are relatively new and sometimes come with high price points. Demand may also be impacted by the availability and competencies of licensed treatment facilities, since these facilities must adhere to strict guidelines for managing, storing, and delivering treatments. Another critical link in the supply chain for gene and cell therapy is efficient scheduling. To guarantee that cell extraction, shipment, production, and delivery occur at the appropriate times, manufacturers, patients, and freight providers must collaborate at every stage. Advanced supply chain software that can handle complex supply chain coordination is required to scale up these processes.
To guarantee the safe and effective delivery of these life-saving therapies to patients, the cell and gene therapy supply chain poses special difficulties that call for creative solutions and exacting attention to detail.
