Issue link: https://www.e-digitaleditions.com/i/1373953
Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 41 net of Things sensors has enabled the technology to become quite ubiquitous in the life sciences supply chain for tracking purposes. The progressive adop- tion of technologies like artificial intelligence and machine learning have also drastically expanded real-time knowledge of the supply chain where gaps may have previously existed. For example, if a prod- uct is out of temperature compliance, a truck driver or manufacturing plant manager can get a text tell- ing them which product is compromised and how much time they have to fix it. Production and distribution of COVID-19 vac- cines is a complex ecosystem, with many hand- offs, but losses cannot be afforded. In addition to maintaining the cold chain, security and prevent- ing diversion is a concern. Real-time visibility is crucial, and the industry is now rushing to put in the infrastructure for it; we're seeing rollouts with very aggressive timelines. The entire path from the manufacturing facility to the distribution point is tracked so that suppliers can know about any deviations. In our digital visibility system, we use artificial intelligence/machine learning rules based on business inputs to predict deviations or delays. We're also tracking the temperature and conditions to be sure product quality is main- tained; containers are instrumented and the sys- tem monitors if a container door is opened or if temperature drifts, for example, and automatically sends alerts. Herjolfsson (Controlant): There are several risk fac- tors in the cold and ultra-cold chain of COVID-19 vaccine distribution, and really most vaccines in general. First, the vaccines must be stored at low and ultra-low temperatures, some much lower than the usual cold-chain standard of 2–8 °C. Any devi- ations in temperature during transport or storage can render the vaccine ineffective or even unsafe. Additionally, there are multiple hand-off points along the supply chain, and each one poses risks of temperature deviations, pallets being split, or other incidents that can compromise the products' quality condition. Likewise, the receiving facility staff must review and understand all handling and storage instructions for each vaccine. Most supply chains using passive loggers only receive descriptive data, showing what happened after the fact. This delay is problematic because stakeholders cannot act on the data to prevent waste and loss. Vaccine integrity has never been more crucial as millions of COVID-19 treatments have already shipped, and potentially billions over the next 12 to 24 months. Controlant is providing monitoring and supply chain visibility services to Pfizer relating to the global distribution and delivery of its COVID-19 vaccines. Pfizer and its partners have been able to keep the excursion rate extremely low. We are also working directly with the US government to help ensure distribution continuity during hand-off, ac- tionable communication, and visibility throughout the entire US supply-chain journey of the Pfizer COVID-19 vaccines. We are also monitoring ad- ditional COVID-19 vaccines through logistics pro- viders during distribution in some countries. "In recent years, the democratization of Internet of Things sensors has enabled remote tracking technology to become quite ubiquitous." —Mahesh Veerina, Cloudleaf