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40 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m the global distribution of its COVID-19 vaccines. Herjolfsson says that collaboration throughout the supply chain is crucial. "We first learned this [les- son] in our work on H1N1 in 2009, and it contin- ues to be Controlant's guiding principle since we started: digitally connect the end-to-end supply chain," he says. Tracking technology and supply-chain visibility systems provide the ability to closely monitor ship- ments to ensure that temperatures are maintained and doses arrive as expected, providing real-time data so distributors can intervene if needed. Con- ventional technology, typically passive data loggers inside of a package, do show the receiver of the shipment that the temperature was maintained, but do not provide such real-time data. "Pharmaceutical companies must have quick, ac- curate, and comprehensive capabilities in place to sense where product is as well as the condition it is in," agrees Mahesh Veerina, CEO of Cloudleaf, whose digital visibility software is being used in the phar- maceutical cold chain by companies such as CSafe Global, which added the visibility system to its air cargo containers for vaccine distribution (2). Cold Chain Technologies, a thermal packaging provider, launched the Cold Chain Technologies Smart Solu- tions using Cloudleaf 's tracking systems in March 2021 (3). The digital informatics platform will track critical parameters, such as location, temperature, and vibration, along with data about weather, traf- fic, and f light schedules, for example. "It will not only remove blind spots in the supply chain, but flag potential issues so that they can be rectified before any product is compromised. Having real-time vis- ibility into vaccine and drug shipments is critical in mitigating loss," says Ranjeet Banerjee, CEO of Cold Chain Technologies. "The need for life sciences companies to have in- sight into their cold chains has never been more apparent than with the COVID-19 vaccine rollout," notes Banerjee, who reported that the company has tripled its production of temperature-sensitive parcels for vaccines in recent months (3). Pharmaceutical Technology spoke with Herjolfs- son and Veerina about vaccine distribution and advances in cold-chain monitoring. Cold-chain challenges and successes PharmTech: What are the biggest risks to vaccines in the cold chain, and how are visibility systems being used to mitigate these risks? Veerina (Cloudleaf): Historically, cold-chain part- ners to the pharmaceutical industry have used a variety of siloed data sources to get supply-chain information, including manual methods such as hand-held bar-code scanners and passive tempera- ture measurements from data loggers. These siloed data do not give information about when, where, and why a temperature excursion occurred. Further, when shipments needed to be located, companies relied on email and phone calls to access needed information. These methods will be insufficient for a coordinated effort of the magnitude needed for the current COVID-19 vaccine distribution. To ensure that temperature-sensitive products don't spoil or get damaged during transport, compa- nies require accurate, reliable, and complete track- ing information. Individual, end-to-end dosage- level tracking would drastically increase efficiency and planning accuracy in distribution, particularly to lesser developed and rural geographies where delivery routes are less formal and technologically equipped, by using remote tracking and monitor- ing. In recent years, the democratization of Inter- Operations