Jan/Feb 2021 • PharmaTimes Magazine • 28
// OUTLOOK //
COVID-19’s continued influence
By Dave Williams
As we enter 2021 and reflect on 2020, the pandemic pushed pharmaceutical and cold chain industries to work in unprecedented ways to innovate through vaccine development, temperature-controlled packages that met the needs of new deep-frozen vaccine storage and increased demand for existing products.
These cold chain industry predictions highlight how COVID-19’s influence persists in 2021 and may have a long-term ripple effect.
Return to refrigerated temperatures
By December 2020 there were 78 different COVID-19 vaccines in clinical trials, under regulatory review for approval or approved for use. With three already approved for use in the UK, we expect the number of approved COVID-19 vaccines to grow in 2021.
It’s likely the market will favour vaccines requiring refrigerated temperatures of 2-8 degrees Celsius (°C). Existing infrastructure is pervasive to more easily transport and store these vaccines globally. Additionally, refrigerated temperatures eliminate concerns around shortages of dry ice and 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 -80°C to easier to distribute ranges of -50°C, -20°C or even refrigerated.
Outsourcing the cold chain
Pharmaceutical supply chains continue to reach new levels of complexity, challenging 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.
It’s predicted more pharmaceutical companies will outsource these capabilities to CMOs and CDMOs, which will help them reduce overall costs. We believe CMOs and CDMOs will expand to include more services. Offering end-to-end expertise will help reduce complexity by standardising as many pieces of the supply chain as possible.
Bringing 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 enrol global patient populations. Frequent travel to a clinical site for routine drug administration, sample collection and simple tests can deter patients from participating, especially when patients don’t live nearby.
Currently, 24% of clinical trials offer solutions allowing patients to receive medical care at home or ship study samples from their homes to a medical facility. This number’s expected to increase out of necessity and for convenience.
COVID-19 increases the chances home-based offerings will grow outside of clinical trials. In 2020, healthcare companies and consumers learned it’s possible to receive healthcare at home. We expect 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 requiring 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.
Dave Williams is the president of Peli BioThermal, a division of Pelican Products