Handle with Care or Pay the Price
The pharmaceutical industry loses billions of dollars annually when drugs stray from their temperature ranges in the “cold chain.” New, personalized therapies and biologics, which have to be quickly accessible at care points or delivered to patient homes, are even more temperature sensitive—and mandate a digital transformation of the cold supply chain, for tighter control of the process via near-real-time access to continuous streams of vital data.
The cold chain provides unbroken custody of perishable product, through a series of refrigerated steps and handoffs during storage and distribution, to maintain a specified temperature range from point-of-origin through final consumption. That’s a lot of touch points for things to go wrong—from the drug manufacturing facility, to the wholesale distribution points, and on to hospitals, clinics, and even direct, last-mile delivery to patients at home.
When Temperature Controls Fail
For example, an article in Pharmacy and Therapeutics references an incident when a single lot of an IV formulation was subject to sub-freezing temperatures outside its acceptable range en route to a distribution center. This failure of temperature control management led to a recall and warnings to patients—the variance could cause emulsion droplets to enlarge into aggregates that blocked pulmonary circulation and might lead to serious problems.
That’s why the Internet of Things (IoT) is crucial—sensors that can monitor, trace and emit continuous data on temperature, humidity, and factors like light, vibration, and shocks. Another must-have is a single, unified, digital collaboration platform, where all this data can be collected and stored for reporting and analysis—with machine learning support to analyze the data, uncover patterns, and prescribe actions to improve quality and process.
Transporting Customized Medicines and Biologics
The cold chain is of vital importance to personalized medicines. These customized therapeutics are more likely to be shipped in single lots—called less-than-truckload (LTL) —making it difficult to standardize temperature management for individual batches when they are mixed with products requiring differing or no temperature controls. Supply chain planning and optimization is vital here. For example, Delmia Quintiq, a Dassault Systèmes company, is working with a transportation concern to optimize loading and route optimization of LTL collections of orders that need temperature integrity across multi-compartment, multi-temperature loads.
Temperature-sensitive biologics are also vulnerable to out-of-tolerance cold supply chains. These drugs contain highly sensitive living cells and tissues. Storage, handling and transport must be tightly controlled, and monitored on the digital platform through IoT real-time data.
Challenges in Emerging Markets
The increase in global clinical trials also has a cold chain component. More drugs are being shipped to patients in other countries for trials than in the past—problematic when the medications are destined for emerging markets with more supply chain disruptions, through infrastructure risks, regulatory snafus, delayed flights, and so on.
This has led to an enhanced focus on Good Distribution Practices (GDPs)—similar to Good Manufacturing Practices (GMPs)—to ensure that pharmaceutical products are stored in the proper way at all times, with digitally enabled compliance to acceptable temperature limits.
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