The global cold chain market is poised to grow around 7.8% over the next decade to reach approximately US$339.15 billion by 2025. One of the biggest driving forces behind this growth is the rising demand for pharmaceuticals that require temperature-control infrastructure and technologies. “Currently, more than 80% of the world’s pharmaceutical products require some form of temperature management to ensure product quality and efficacy is maintained, and this requirement will continue to grow with the expanding range of biopharma products entering the supply chain,” said Zuellig Pharma Corporate Head of Quality Assurance, Brett Marshall.

The efficacy of today’s higher value and structurally complex drugs can be destroyed through a single cold chain break, the integrity of controlled room temperature products can be impacted through inconsistent environmental conditions during distribution, while a weak link in the management of temperature sensitive clinical trial materials can impact study outcomes and lead to extremely costly delays in bringing new products to market.

These challenges, along with the globalization of supply chains and increased regulatory requirements, makes temperature management throughout the pharmaceutical industry a difficult but urgent matter to manage.

Changing market needs

One of the most significant changes within the pharmaceutical industry in recent years is the evolution of drug portfolios.

Many manufacturers are moving away from chemical pharmaceuticals towards more structurally complex biotechnology drugs. Biologics accounted for 29% of branded global pharmaceutical sales in 2014, while specialty drugs accounted for one-third of total drug costs in 2016 with expected growth to 50% in 2020.

Biologic pharmaceutical products have much stricter handling requirements and failure to adhere to these requirements at any point in the drug’s lifecycle can impact product quality and efficacy, put patients at risk or result in significant product waste and supply chain disruption.

Vaccines are one of the most common type of biologic drug that requires handling at temperatures between 2°C - 8°C to maintain its efficacy and safety. Any break in this cold chain, from production, to storage, transportation, or usage could damage the integrity of the vaccine, resulting in reduced efficacy and safety in treatment.

According to the World Health Organization, more than 50% of all vaccines manufactured in the world each year are destroyed during the storage and delivery process. To cope with this problem, the pharmaceutical industry has been investing in new solutions to mitigate the risk of temperature excursions. Zuellig Pharma’s eZCooler packaging system is one example of this. The eZCooler extends the holding time of temperature sensitive products to five days, versus two days with traditional systems ensuring the integrity of products to the last mile of distribution.

In the hot, often temperamental climates in Southeast Asia, this system has a big role to play in helping to ensure temperature-sensitive products reach their destination in good condition, particularly in remote, rural areas.

Clinical trial management

These changing needs impact the storage and distribution of finished products and impact clinical trial logistics. Biologic drugs are more sensitive to the external environment, requiring cold chain handling and more regulatory approvals during the clinical trial process. This can add significant cost to the trial and lead to study and drug approval delays.

Waste due to temperature excursions can therefore easily lead to stock-outs of required products, an inability to supply enrolled patients or re-supply issues for patients already under treatment in a randomized study. This could delay studies, pushing back the introduction of a new treatment or drug for patients and costing the trial sponsor millions of dollars in R&D costs as well as potential sales.

Compliance

Regulators are placing a much higher level of scrutiny on quality systems and processes and temperature management is one key element of this. Regulatory bodies require proof that all drugs and biological components have been distributed within the required temperature range – meaning all processes and sub processes need to be validated to ensure there has been no negative impact on the safety, efficacy or quality of a product.

To do this, monitoring and reporting technology such as temperature monitors, sensors and track and trace systems are used. Much of this reporting is currently provided on a historical basis, at the end of a journey or delivery, but there is a growing trend towards real time monitoring which will provide alerts if the temperature deviates beyond the safe range.

Companies need to invest in more sophisticated supply chain infrastructure to comply with new regulations and while this can be costly, the cost of non-compliance is likely to be much higher. A single consignment of drugs being distributed can be worth millions of dollars and a cold chain break can mean an entire shipment needs to be written off while a recalled batch of drugs due to temperature excursion can lead to significant reputational damage or regulatory scrutiny.

How we help

Zuellig Pharma takes quality very seriously. All our warehouses are Good Storage and Distribution Practice (GSDP) and Good Distribution Practice (GDP) certified with annual audits to help us stay on top of quality management standards and develop more efficient processes.

Our Specialty Solutions Group maintains a network of 14 clinical trial depots across Asia, offering integrated storage, distribution, returns and destruction, re-labelling and a comparator drug-sourcing service.

Having supported over 1,800 clinical trials, our network of local and central depots have the knowledge and experience to provide a one stop shop clinical trial support. This enables sponsors to customise their clinical supply chain set-up for each study, taking into account regulatory considerations, risk aspects, required shipment turnaround times, and geographical focus, with the aim of balancing study objectives against cost. We have shared our cold chain practices with governments around the region.

In late 2017, we partnered with two departments under the Ministry of Health in Vietnam to support them in strengthening their cold chain capabilities nationwide. This involves working on a two-year programme with the National Centre for Control of Vaccines and Biologicals and the National Institute of Hygiene and Epidemiology, to enhance cold chain storage management and train more people in the careful handling of vaccines during distribution across Vietnam.