Embracing new innovations and technology is at the forefront of the cool chain sector. Keith Mwanalushi asks how the temperature-controlled container industry is responding to the ever-demanding pharma supply chain.

In September, the Cool Chain Association (CCA) is meeting in Paris, to discuss and share thoughts on collaborative solutions for innovation and data sharing at its 7th Pharma and Biosciences Conference. Indeed, innovators with new solutions are exploring how they can work together to provide the infrastructure needed to ensure a successful end-to-end cool chain delivery.

The pharma sector has become big business for the air cargo industry and the value of the temperature-sensitive supply chain is evident. For instance, Swiss-based SkyCell and Emirates SkyCargo have been cooperating for two years now in pharma shipments across the globe without a single temperature excursion during joint transports, according to both companies.

SkyCell’s patented containers recharge automatically in Emirates SkyCargo’s cool chain network, thus enabling “door to door” delivery for a closed supply chain and have close to real-time temperature monitoring capability.

Back in June, SkyCell announced a partnership with United Cargo which made it the first U.S. carrier to lease and transport the innovative temperature- sensitive containers manufactured by SkyCell as part of its TempControl service.

“The partnership announcement with United Cargo was one of three partnerships that were announced within ten days, each of them marking an important step for SkyCell and our clients towards a safer pharma supply chain,” states Richard Ettl, CEO.

According to SkyCell, their creative use of technology enables them to offer safe and highly reliable logistics services for biopharmaceuticals and other products sensitive to even slight changes in temperature.

“TempControl’s transport of vaccines and other high value biopharmaceutical shipments is increasing rapidly,” said Jan Krems, president of united cargo. “Extremely precise, long duration temperature control is required for the safe transport of these highly sensitive shipments.”

Based in Germany, va-Q-tec provides solutions in the thermal insulation and temperature chain logistics field, and has been investing heavily in digitalisation to further increase product safety in its business segment services.

Since 2003, the company has been producing passive, thermal packaging solutions, primarily for the transport of pharmaceutical products. From 2011, va-Q-tec started to rent the boxes and containers, which can keep the temperature inside constant for five days and more without an external power supply.

To date, the company has built a global network with 27 so-called TempChain Service Centres (TSC) and maintains a rental fleet of 2,000 containers and several boxes. The packaging solutions are preconditioned by the TSCs to the requested temperature and delivered to the customer ready to “load and go”.

Containers must adhere to very strict temperature tolerances that must be observed and to supposedly strike a balance between meeting the growing demand for temperature-sensitive pharma and ever stricter regulatory compliance standards.

SkyCell’s line of passive containers keep the internal temperature within the range of +2°C to +8°C and +15°C to +25°C under extreme temperature (70°C to -30°C) for more than 160 hours.

Global pharmaceutical companies are shifting their focus towards biologics, which are particularly temperature sensitive. “Therefore, the regulatory environment is becoming more and more strict, which means that supply chains must be absolutely robust,” suggests Ettl.

In order to counteract this complexity and create worldwide quality standards, SkyCell is making the connection between quality and technology. Since 2013, each of the containers is equipped with Internet of Things IoT sensors that connect to SkyCell’s cloud-based, blockchain-encrypted software.

The resulting data is used both to monitor internal performance and to simulate future shipments using the SkyCell Transport Planner.  These sensors monitor temperature, humidity and other factors to ensure the best possible protection against excursions.

“State of the art technology enables Skycell to be completely transparent about the results of our shipments as well as increase controllability of the entire supply chain,” he adds. In recent years, the demands on the temperature- controlled supply chain, which va-Q-tec calls TempChain, have risen sharply.

All over the world, even in emerging markets, Good Distribution Practice (GDP) regulations are being introduced or tightened. This standard requires complete control of temperature, humidity and other parameters, especially in the case of unforeseen delays during transport, e.g. inadequate infrastructure or unscheduled delays in customs clearance, which make avoiding temperature deviations a major challenge.

In addition, the pharmaceutical supply chain is increasingly organised globally. Pharmaceutical products are manufactured, packaged and distributed at different locations worldwide. Clearly, clients expect that the right packaging solution of the right size and temperature will be available on short notice.

Positioning the fleet in line with global requirements and optimally planning maintenance and repair cycles is the second major challenge for a company like va-Q-tec. The industry is tackling the growing demand for faster and more predictable lead times for the pharma and clinical research sector, given the regulatory complexities that can delay exports.

Ettl observes two ways to encounter faster and more predictable lead times; a date-driven supply chain and a high service quality level. He explains: “Pharma companies must rely more and more on external partners for manufacturing, selling and transportation as a reaction to globalisation. We believe that data transparency will be necessary to operate such an increasingly global supply chain.”

A connected supply chain is a fundamental prerequisite for gaining visibility and control over the supply chain, leading to shorter lead times. Ettl says SkyCell recognised this demand at an early stage and established tools and processes to support pharma companies in this shift.

One example is the SkyCell Transport Planner which was launched in 2013: “It enables clients to simulate shipments and assess high-risk lanes before conducting an actual shipment.”

Another way to reduce lead times, is a reliable supply chain that assures that no product is damaged during transport. Ettl continues: “SkyCell offers a high service quality level that ensures that life-saving pharmaceuticals are at the right place, at the right time and most importantly, in perfect condition.

To achieve this, we work with pharmaceutical shippers, airlines and forwarders to establish standard operating processes [SOPs] for each individual lane. “For pharmaceutical companies, a reliable supply chain without product losses is key to fast product releases and short lead times. Thus, the supply chain will become a more and more powerful competitive weapon like we observed it in the FMCG or tech industry.”

Lately, ULDs and other cargo containers are seeing somewhat of a technological evolution. It’s widely agreed that the air pharma supply chain is complex but if all stakeholders share data in the movement of shipments it can help reduce costs, improve efficiency and ensure temperature excursions are kept to a minimum SkyCell uses Big Data for internal quality control and risk analysis of routes.

The goal is to build a future-proof supply chain with its clients and thus eliminate product losses due to temperature excursions in the pharma supply chain. “We are therefore exploring the potential of new technologies. For instance, we see great potential in blockchain technology as it shares our values of transparency and reliability.

“But if you look at the big picture, the biggest change cannot be found in a single technology or in the ever-improving performance of the containers. We rely much more on a creative combination of hardware, software and services like Tesla, Apple or Amazon,” Ettl points out.

In terms of the challenges affecting the cold chain air freight market sector today, Ettl sees increasing regulation not only on the side of quality and integrity, but also on the environmental side.

“For obvious reasons, all pharma companies are already operating under strict environmental controls.” He reckons these regulations are likely to become even stricter as international efforts are made to limit CO2 emissions.

Another challenge Ettl sees are the constraints against disposable solutions: “More and more countries, such as Taiwan or China, prohibit the import of one-way solutions or charge high fees,” he notes.

No doubt the global cool chain community will derive significant benefits by getting together to share best practice and innovation to create a seamless chain for the handling of pharma products and develop solutions to challenges faced in the sector.