With the emergence of the cell and gene therapy industry, a new set of supply chain challenges has come to the forefront. Biopharmaceutical companies find themselves in the position of needing to optimize their distribution networks and supporting infrastructure to transport biological materials while adhering to strict temperature controls and tight deadlines. These therapies demand advanced logistics solutions to ensure optimal efficiency and timely delivery of doses to patients.
The value and commercial potential of cell and gene therapies are significant, as they offer reliable treatments for patients. However, realizing these benefits relies on the ability of companies throughout the supply chain to effectively overcome the challenges associated with distributing these materials. Given the intricacies of this logistical puzzle, companies must seek solutions that provide visibility and optimization for the gene and cell therapy supply chain.
The delivery process for cell and gene therapies is a complex system that demands high visibility and collaboration from supply chain partners with specialized capabilities. The specific steps involved in the gene and cell therapy supply chain vary depending on whether the therapy is autologous or allogeneic. Nevertheless, both supply chains share the common goal of delivering treatments and associated care to the patient effectively.
Cell and gene therapies necessitate specialized supply chain solutions beyond those typically used in the pharmaceutical industry. Consider the following challenges related to cell therapy transportation and strategies to mitigate them:
- Quality Sensitivity
Cell and gene therapies exhibit high sensitivity to quality. These small cell batches have a limited shelf life before their quality deteriorates. Therefore, it’s imperative to employ effective preservation methods and maintain a cold chain throughout the supply chain. Achieving optimal shipping temperatures, which are extremely low, requires meticulous attention, with cryopreservation temperatures around negative 120 degrees Celsius (or negative 184 degrees Fahrenheit). Treatment centers authorized to handle these therapies must also possess the capability to properly store, handle, and thaw the drug products. The conventional pharmaceutical supply chain infrastructure is ill-suited for these heightened requirements. Complete visibility into the supply chain is essential to enable logistics partners to plan for contingencies and streamline workflows.
- Process Tracking
Cell and gene therapies mandate rigorous monitoring of the chain of identity (COI) and chain of custody (COC). COI tracking ensures that drug products remain traceable and identifiable throughout their journey, beginning from raw material extraction through manufacturing and treatment. COC refers to the possession of drug products by stakeholders at various points in the value chain. Establishing end-to-end process tracking is pivotal for ensuring the safety and quality of these products.
- Real-Time Communication
Effective communication is critical at every stage of the gene and cell therapy supply chain, especially during therapy delivery. Due to the time-sensitive nature of these therapies, authorized treatment centers must be equipped to receive drug products and administer treatment to patients rapidly. These treatment centers are often strategically located to serve areas with high patient concentrations. However, some patients may need to cross state or national borders to access care. Upon drug product delivery, doctors must promptly communicate with patients to prepare them for treatment administration at the bedside.
- Quality Monitoring
Monitoring product quality is paramount in gene therapy supply chains. Several factors, such as temperature, dwell time, color, and sedimentation, can affect and indicate the quality of cells and drug products. It’s imperative to monitor these elements at every step of the supply chain. The advent of smart technologies like the Internet of Things (IoT) has made it possible for stakeholders to access real-time shipment data. IoT sensors gather data on each shipment, including cell concentration, temperature, location, pressure, and color abnormalities. Additionally, supply chain software provides enhanced visibility, allowing stakeholders to monitor product quality and safety.
- Time Constraints
Cell and gene therapies adopt a just-in-time manufacturing approach to enhance production and delivery efficiency while preventing spoilage. From cell apheresis to treatment, time is of the essence for all stakeholders to ensure timely processes. The urgency associated with these therapies places increased demand on stakeholders to accurately forecast market demand, avoid overproduction, and mitigate potential delays. Shipments must be precise yet flexible to ensure the timely delivery of treatment to patients.
- Demand Planning
Cell and gene therapies are relatively new and often come with high price points, making demand planning a complex endeavor. The availability and capabilities of authorized treatment centers can also impact demand since these centers must meet specific requirements for storing, handling, and administering therapies. Effective scheduling is another crucial aspect of the gene and cell therapy supply chain. Manufacturers, patients, and freight suppliers must coordinate at every step to ensure the proper timing of cell extraction, shipping, manufacturing, and delivery. Scaling up these operations necessitates advanced supply chain software capable of managing intricate supply chain coordination.
The cell and gene therapy supply chain presents unique challenges that require innovative solutions and meticulous attention to detail to ensure the safe and efficient delivery of these life-saving treatments to patients.