What does pharmaceutical cold chain involve?
Whatever the circumstances, the pharmaceutical industry must provide a high level of quality, from the manufacturing of health products to their dispensing to patients.
As they are sensitive to temperature fluctuations, drugs require different types of attention, such as temperature-controlled transport, which is generally handled by logistics service providers. These requirements are specified in the marketing authorization granted to the medicine.
Most drugs are stored in a controlled environment, and more specifically between 59 °F and 77 °F. Vaccines and biotechnologies often need to be stored in positive cold between 35,6 °F and 46,4 °F. Some even require negative cold, such as messenger RNA vaccines, which are stored at -4 °F or even -94 °F.
The pharmaceutical logistics market in France represents today more than 3.5 billion euros, and the market for cold logistics products is estimated at 690 million euros, i.e., approximately 20% of the total, with two thirds of this amount being devoted to storage and one third to transport.
This trend is likely to continue. In a dedicated study, Les Echos predicted a 70% growth in temperature-sensitive products by 2025. This is due, among other things, to the success of biotechnologies, including so-called biosimilar drugs, and the development of new cancer treatments. "Changes in the product mix and the health context are generating a growing demand for temperature-controlled logistics and transport services", summed up the economic media group. This analysis is also confirmed in the last cold chain market research report by MarketsandMarkets™.
An increasingly regulated and secure environment
The pharmaceutical industry must comply with good manufacturing practices or GMPs and good distribution practices or GDPs to ensure product integrity. The strict application of these rules varies depending on the geography and the country. Some EU countries such as Germany and Austria have even tightened their application of the GDPs.
Regarding the availability of drugs of major therapeutic interest such as cardiovascular drugs, nervous system proprietary drugs, anti-infectives and cancer drugs, pharmaceutical companies have been required to keep a two-month safety stock in France since March 30, 2021. The French National Agency for the Safety of Medicines and Health Products (ANSM) may increase this period to four months in the event of a shortage.
In addition, a serialization scheme was launched in February 2019 to strengthen drug security and ensure their authenticity, safety and quality in Europe. This subject of serialization will be the topic of an upcoming dedicated article.
The operational complexity of pharmaceutical cold chain logistics
These factors translate into higher operational complexity which requires to fully control the end-to-end supply chain. For example, drugs that are manufactured in Asia might be shipped to Europe and then delivered at national level. At each of these processes, cold chain must be guaranteed. Specific active packaging solutions (energy-powered container) and passive packaging solutions (certified packaging to maintain a constant temperature for a certain period of time) are necessary to manage international flows (air and sea).
This also implies complete tracking and tracing of shipments throughout the supply chain. Technological tools such as data loggers and sensors are used for measurement and information feedback with a view to checking the conformity and integrity of the goods at their destination.