In light of the need for COVID-19 vaccines to be kept at temperatures as low as -70C, Dave Williams, president of Peli BioThermal, looks at how the supply chain is adapting to meet this challenge.

As we eagerly enter 2021 and prepare this year’s cold chain industry predictions, we reflect on the events of 2020. Nowhere leading into the year did we predict a global pandemic. Yet its impact crosses all facets of business, causing companies to pivot and adapt. Some were able to harness new opportunities to serve our ever-changing way of life and others struggle to stay the course.

The pharmaceutical and cold chain industries were pushed this previous year to innovate through vaccine development, temperature-controlled packages that met the needs of new deep-frozen vaccine storage, and increased demand for existing products. They 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 show how COVID-19’s influence persists, and in some instances, may have a long-term ripple effect.

Return to refrigerated temperatures for COVID-19 vaccines

As of December 8, 2020, 78 different COVID-19 vaccines are in clinical trials, under regulatory review for approval or approved for limited use. We expect that the number of viable, approved COVID-19 vaccines will continue to grow in 2021.

All else equal, it is likely the market will favour vaccines that require refrigerated temperatures of 2-8 degrees Celsius. Existing infrastructure exists to more easily transport and store these vaccines around the world. 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 push pharmaceutical companies with deep-frozen vaccines to determine how to maintain efficacy of the vaccine at a refrigerated temperature. If this happens, we will gain knowledge that will move pharmaceuticals’ current storage and distribution temperature from -80C to easier-to-distribute ranges of -50C, -20C, or even refrigerated.

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 the 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 them reduce overall costs. We also believe CMOs and CDMOs will expand to include more services. This will include cold chain, working with partners like us. Offering end-to-end expertise will help reduce complexity by standardising as many pieces of the supply chain as possible.

Growth in direct-to-patient and direct-from-patient brings cold chain to the last mile

Over the past several years, clinical trials have become increasingly complex. They require extensive data collection, utilise complicated drug regimens, and enroll 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% 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.

COVID-19 also increases the chances of home-based offerings growing outside of clinical trials. Over the past year, healthcare companies and consumers learned that it is possible to receive healthcare 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 toward 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.