As revealed by the pandemic, seamless logistics is key, especially when it comes to dealing with the specificities and complexity of the pharma cold chain.
But what does that actually refer to? In this first article, we address the specific logistics challenges in the pharmaceutical cold chain, linked to the sensitivity of the products and their access to patient. We will focus on temperature sensitive drugs, most of them being derived from living organisms, and how to ensure a reliable management of the cold chain in order to guarantee their integrity.
In a second article to be published soon, we will help you gain insight into available solutions and into post-Covid perspective.
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.
What are the specific challenges of pharmaceutical logistics?
The advent of new technologies like messenger RNA is driving the pharmaceutical logistics sector to expand its service offering.
A predominance of sensitive products, especially biotechnologies
Biotechnologies which combine life sciences (biology) with new technologies such as computer science, physics and chemistry, also require special care throughout the cold chain. This sector is expanding rapidly, particularly in France, the United States and Japan. In 2019, it comprised a total of 820 listed biotech companies in the world, with a cumulative valuation of $1,060 billion.
Vaccines are what first come to mind in terms of biotech products. Did you know that pharmaceutical companies produce an average of between 3 and 5 billion doses per year? In 2021 alone, more than 12 billion doses of Covid-19 vaccines were produced worldwide.
The current pandemic is representative of the issues related to cold chain management. Indeed, the Moderna vaccine must be stored at -4 °F, and AstraZeneca's between 35,6 °F and 46,4 °F. Pfizer's product must be stored at -94 °F and then thawed prior to its injection into patients. Once thawed, it can be stored for four days at between 35,6 °F and 46,4 °F prior to injection, which is the temperature level at which most vaccines and drugs are normally stored and delivered.
To maintain these sometimes exceptionally low temperatures, dry ice can be used to transport certain vaccines and dispatch them to hospitals, vaccination centers and pharmacies.
Progress in Medical sector inspires new ways of envisioning the supply chain.
Expensive but necessary investments
To ensure the continuity of operations and cold chain warranty, investments will be key both to develop temperature-controlled storage areas and adapt the vehicle fleet. In the future we can expect to see a concentration of road transport and final distribution players to meet the growing demand for temperature-controlled capacities.
To this end, GEODIS has acquired a specialized company Gandon Transports to enhance its health offering.
"From inventory planning to temperature-controlled storage and transport to the final recipient, we want to offer our customers a complete and reliable solution throughout the supply chain", explains Marie-Christine Lombard, Chief Executive Officer of GEODIS.
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This article has answered your questions about the challenges of pharmaceutical cold chain logistics. If you are wondering how to deal with it in practice, we invite you to read our second article which presents not only the solutions, but also the key takeaways from the Covid-19 pandemic... We hope you enjoy reading it!