A cold chain is a temperature-controlled supply chain. It typically involves constant refrigeration of the product from the time of its production through its transportation, handling, storage, and delivery. A cold chain is required to preserve and maintain the usability of products like food items, chemicals, and now increasingly, pharmaceutical products.
The pharmaceutical industry was historically not a big consumer of cold chain logistics since the majority of its drugs had no such requirement. Only in the recent past, there has been an explosion of cold chain activities with the growing acceptance of a new class of drugs called biologics. They have only recently come into the world of medicine but have already taken the market by storm, not only in terms of their treatment capability but also in terms of the demands they are placing on the pharmaceutical supply chain. Most biologics require both temperature and time-controlled distribution.
Apart from biologics, recent times have also seen the emergence of different types of precision medicine breakthroughs like cellular therapies, biomarker testing, and regenerative medicine in the form of stem cells. Transportation of material to enable the completion of these therapies come under the ambit of cold chain. Blood products and certain vaccines also need a cold chain for their preservation.
According to the 2017 edition of Pharmaceutical Commerce’s annual Biopharma Cold Chain Sourcebook, the growth of temperature-controlled products is occurring at more than twice that of non-temperature-controlled products, indicating how important cold chain is going to be in the pharmaceutical supply chain in the times to come. Another push for cold chain comes from the reinforcement of Good Distribution Practices (GDPs) and specifically, their insistence on temperature monitoring for all types of pharmaceutical products to ensure better quality assurance, thereby gradually blurring the line between refrigeration-requiring products like biologics and those that didn’t require it like tablets.
The slow but sure spread of biologics and biosimilars to hitherto untapped markets like Asia is another factor contributing to the potential rise of cold chain system. According to an article on PharmaiQ, airport mishandling is one of the biggest causes of cold chain breaches. As the demand for temperature-controlled products spans further over the oceans, there will be a big increase in the number of airports serving as transit points and the risk of breaches will then get even bigger. This will demand massive infrastructural and procedural investments from stakeholders in the cold chain.
In 2013, out of the top 50 drugs, there were 24 drugs which required cold supply chain. By 2020, it is estimated that this number will increase to 27. In 2015, the biopharma cold chain spending is estimated to have been $10 billion — $7 billion on transportation and the remaining $3 billion on specialized tertiary packaging and instrumentation. The estimates for 2016 and 2017 are $12.6 billion and $13.4 billion respectively, giving us a fair idea of the future scale of cold chain.
To understand the complexity of cold chain logistics, let us consider the following: 28 out of 57 products approved by the FDA in 2017 are cold chain products, 23 of which require 2-8 degree Celsius temperature conditions, and five require sub-zero or cryogenic temperatures. The cryogenic products have their own specifications; one require a range of -35 to -15 degrees Celsius, and three others need -65 degrees Celsius, -120 degrees Celsius, and -150 degrees Celsius, respectively. The 23 mentioned on top need to be kept unfrozen to uphold their utility. The non-cold chain ones have their own varying specifications; 20-25 degrees Celsius is what most have to conform to with a leeway to expand to 15-30 degrees Celsius, some specify 2-25 degrees Celsius, and one mentions up to 30 degrees Celsius but not frozen.
Transporting sensitive biomarkers, therapies, and patient samples require exact time-limited logistics support. It is quite possible to see three to four different temperature requirements in a single cold chain for a regenerative therapy. Some transportation deadlines have to be met within hours instead of days.
Temperature management in the cold chain currently is being done through various ways. The most basic process involves packing discrete devices called temperature data loggers along with the shipment, which will record a temperature reading of the product that can be manually uploaded into a system. More sophisticated data loggers have the ability to measure temperature, shock, humidity, vibration, and other attributes. Some may have GPS capability and the possibility of real-time tracking and reporting. A few can communicate via RFID to make it easy to gather information.
RFID hardware can also be used along with software solutions to retrieve and track information from data loggers. Rapidly evolving software platforms are being developed for end-to-end tracking. Informatics will have a central role to play in efficient data generation and monitoring.
Also available in the fray are packaged-based temperature control solutions. Some of them are passive and maintain prespecified temperature conditions. Some are active and have the capability to heat or cool the product as necessary.
The main ingredients for maintaining a cold chain are effective digital communication and data collection. The complete integration of the entire supply chain processes, linking them to the data supporting regulatory needs and quality considerations, as well as automating complex patient reimbursement processing is an absolute requirement. This is where a software service provider can have an integral role to play. If it can create a platform which links all data collection devices to an application and gathers real-time temperature data from the products currently in transit and suggests corrective and preventive actions, and correlates the historical performance of a specific piece of packaging equipment to any marked shipment, all at the same time adhering to the major global regulatory laws, it will a big step forward in cold chain logistics.