Issue link: https://www.e-digitaleditions.com/i/1507932
28 BioPharm International ® Emerging Therapies eBook September 2023 www.biopharminternational.com Supply Chain platform so that every step can be tightly synchro- nized remains a continual challenge." Today, many pharma companies working to com- mercialize a CGT or biologic therapy often develop their own proprietary network to coordinate the re- quired cold chain infrastructure. "But as the num- ber of approved therapies continues to grow—with approved CGTs and other precision biologic ther- apies eventually numbering in the dozens or even hundreds—having so many parallel platforms will make it difficult for healthcare providers to under- stand how to use them to achieve the overall objective of ensuring seamless efficiency and greater visibility," says Bermudez. TraceLink's existing end-to-end digital network currently has 290,000 active members (including pharma companies, hospital and healthcare settings, providers of third-party logistics, cold-chain couri- ers, and more) that are able to interoperate seamlessly. "We are working to leverage that existing platform by launching our cell journey service to support CGT stakeholders," says Bermudez. "With an anticipated launch some time in 2024, our goal is to give all CGT participants a single link to connect with each other and manage planning and real-time responses." Looking for insights with algorithms and analytics In the past, cold chain monitoring solutions were lim- ited to measuring and documenting environmental conditions during transport. "Only gradually did users realize the potential that lies dormant in the collected data, especially when the measurement data [are] com- bined with shipment information related to product characteristics, packaging solutions, route, service pro- vider, and more," says Schäpper. "Today, sophisticated data-analysis tools are used to check which routes are risky at which time of year, which packaging performs best for the respective requirements, or which mode of transport is the safest and enable continuous improve- ment in cold chain management." But retrospective data analysis is only one side of the coin. "Software-based know-how or artificial intelli- gence can be used to simulate the impact of changing environmental conditions (such as rising tempera- tures) on a shipment," Schäpper says. Other variable developments related to a delivery can also be antici- pated and built into the simulation (e.g., deviation from a route). "The simulation can then be used to calculate how much stability the product will have left when it arrives at its destination, and conclusions can be drawn as to whether measures need to be taken to secure the delivery," he adds. Such predictive analytics can be used, for example, to assess risk based on a simulation carried out before a delivery. Then, the combination of actual temperature data measured in real time during a delivery, in con- junction with predictive analytics, further mitigates risk. "With this method, real measured developments during the delivery can be extrapolated, and thus a risk assessment can be made," says Schäpper. "AI and ML have the potential to greatly enhance the healthcare logistics industry, especially in cold chain management," adds Coyle. Specifically, he notes that such modeling modalities are already being used for: • Real-time monitoring and tracking to help monitor and track cold chain products' temperature and hu- midity levels in real time • Predictive maintenance to predict equipment fail- ures and maintenance needs, helping logistics com- panies to reduce downtime and disruptions • Route optimization to optimize delivery routes for by analyzing historical data in order to reduce transportation costs and improve delivery times and reliability • Demand forecasting to predict demand and adapt production and supply accordingly, manage in- ventory levels, and prevent overstocking or under- stocking of products • Risk management to identify potential risks, such as delays related to weather or political upheaval, equipment failures, and provide recommendations for mitigating these risks to minimize the risk of product spoilage. Sustainability: A high priority in cold chain logistics Sustainabilit y is another increasingly impor tant consideration within the biologics cold chain. Ac- tive refrigerated packaging is, by design, a more sus- tainable option than disposable packaging because these shipping containers can be used repeatedly. "But this approach also requires a high degree of co- ordination among all participants," says Betancourt. "We can a ll use reusable temperature-controlled packaging, but if we are not able to get the reusable containers back through efficient logistics planning, then it doesn't make sense." In May 2023, CSafe, a provider of active and pas- sive temperature-controlled shipping solutions for the biopharmaceutical industry, announced that is providing a cold chain solution to support Kr ystal Biotech's Vyjuvek gene therapy. Equipped with the company's best-in-class vacuum insulated panel (VIP) technology, the custom thermal shipper design maintains -20 °C throughout the product journey, ac- cording to Csafe. Importantly, the supply chain for Vyjukek will be further optimized by using Csafe's fully managed, end-to-end Retest & Reuse program. Through this program, Csafe team members inspect, clean, and thermally requalify the insulation used in these specialized shippers to ensure thermal integ- rity prior to reuse. This reduces unnecessary landfill waste, according to the company (2).