Cold chain in 2021: COVID-19’s continued influence

Dave Williams explores why the cold chain requirements for COVID-19 vaccines may have a lasting impact on the pharmaceutical supply chain.

As we enter 2021 and prepare this year’s cold chain industry predictions, we have the opportunity to reflect on the events of 2020. At the start of the year no one would have predicted a global pandemic, yet its impact has crossed all facets of industry, forcing companies to pivot and adapt. Some businesses were able to harness new opportunities to serve our ever-changing way of life and others struggled to stay the course of last year.

In 2020, the pharmaceutical and cold chain industries were pushed to innovate during vaccine development, including making temperature-controlled packages that met the needs of new deep frozen vaccine storage and increased demand for existing products. The industry rose to the challenge, working in unprecedented ways to make 2021 a brighter year.

Though there is hope for more normalcy in 2021, COVID-19 will continue to drive business operations; this is certainly true for pharmaceutical and cold chain companies. Our three predictions below all demonstrate how COVID-19’s influence persists and in some instances, may have a long-term ripple effect on the industry.

Return to refrigerated temperatures for COVID-19 vaccines

Cold chainAs of 8 December 2020, 78 different COVID-19 vaccines were either in clinical trials, under regulatory review for approval or approved for limited use. With several candidates having now been approved for emergency use, we expect the number of viable, approved COVID-19 vaccines will continue to grow in 2021.

The market will likely favour vaccines that require refrigerated temperatures of 2-8°C as infrastructure exists to easily transport and store these vaccines around the world, unlike others that require more specialist conditions. Additionally, refrigerated temperatures eliminate concerns around shortages of dry ice and concerns about how it reduces the amount of available cargo space on aircraft.

This preference for refrigerated vaccines could encourage pharmaceutical companies with deep frozen vaccines to investigate and determine how to maintain efficacy of the vaccine at a normal refrigerated temperature. If this happens, we will gain knowledge that will move pharmaceuticals’ current storage and distribution temperature from -80°C to ranges of -50°C, -20°C or even refrigerated, which are easier to distribute.

Outsourcing the cold chain

Pharmaceutical supply chains continue to reach new levels of complexity that challenge even the most seasoned logistics and supply chain professionals. Contract manufacturing organisations (CMOs) and contract development and manufacturing organisations (CDMOs) offer expertise in manufacturing and development of therapies, allowing pharmaceutical companies to focus on their areas of expertise.

This year we expect to see even more pharmaceutical companies outsource these capabilities to CMOs and CDMOs, which will help businesses to reduce overall costs. We also believe CMOs and CDMOs will expand to include more services including cold chain. Offering end-to-end expertise will help reduce complexity by standardising as many sections of the supply chain as possible.

Growth in direct-to-patient and direct-from-patient

Over the past several years, clinical trials have become increasingly complex. They require extensive data collection, utilise complicated drug regimens and enrol global patient populations. Frequent travel to a clinical site for routine drug administration, sample collection and simple tests can deter patients from participating. This is especially true when patients do not live close to a medical facility.

Currently, 24 percent of clinical trials offer home-based solutions that allow patients to receive medical care in their homes or ship study samples from their homes to a medical facility. We expect to see this number increase out of necessity, but also out of a desire for continued convenience experienced during the pandemic.

COVID-19 vaccineCOVID-19 also increases the chances home-based offerings will grow outside of clinical trials. Over the past year, healthcare companies and consumers learned that it is possible to receive healthcare and health services at home. We expect that a subset of the population will continue to prefer home-based healthcare for its convenience, driving more companies to offer this service.

Services like phlebotomy, drug administration and sample collection that require refrigeration will require cold chain solutions. We anticipate a drive towards solutions that require little training and are easy for home healthcare professionals and patients to operate. We should also see more assessment and evaluation of the cold chain for home-based care in 2021.

About the author

Dave Williams is the President of Peli BioThermal, a division of Pelican Products, Inc. Prior to Peli BioThermal, Dave held the position of Vice President of Strategic Initiatives at Pelican Products. He also previously served as Vice President of Capital and Engineering at Technicolor and as Project Director for compact disc pioneer, Nimbus. Dave attended Harvard University in Boston, Massachusetts.