BEHIND THE SCIENCE

 

The mRNA (messenger ribonucleic acid) vaccines used to combat the COVID-19 pandemic have been enormously successful. Though the disease has not been eradicated, the vaccines have prevented severe illness and hospitalizations caused by SARS-CoV-2 and its many variants. ⁱ

 

The speed with which the two mRNA COVID vaccines were developed, approved for emergency use, and then distributed to the public demonstrated an advanced biotechnology platform for immunizations. ⁱⁱ Billions of doses have been administered worldwide, providing a wealth of data demonstrating that the vaccines are safe and effective despite how quickly they were developed. ⁱⁱⁱ The success of this biotechnology platform has increased interest in using messenger RNA in a variety of therapeutics beyond vaccines.

 

New Treatment Potentials

 

Research into biologically targeted mRNA vaccines, as well as mRNA therapeutics, has been ongoing for years. However, the renewed efforts sparked by the COVID vaccine may expand these therapeutics into additional areas.

 

 

• Melanoma
• Gastrointestinal Cancer
• Cystic Fibrosis
• Bone Repair
• Heart Failure
• Wound Healing
• Peripheral Vascular Physiology
• Glycogen Storage Disease (GSD)

 

The Challenge of Thermosensitivity

 

One of the biggest challenges faced following the development of the COVID-19 mRNA vaccine was caused by a new, increased need for ultra-low temperature storage solutions. Certain biopharmaceutical products, like mRNA vaccines, are thermosensitive and must be kept at ultra-low temperatures (often -80°C) during the production process and before administration to the public.

 

Ultra-low temperatures prevent the degradation of mRNA. They also stop other changes in the biophysical properties of mRNA that would negatively impact efficacy. ^vi To achieve ultra-low temperatures and effectively preserve mRNA samples, ultra-low temperature (ULT) freezers are essential.

 

Cold Chain Demand Continues Post-COVID

 

While ULTs have been a staple of research facilities for years, the pandemic broadened their use in clinics, hospitals, and last-mile vaccine administration sites. This led to an unprecedented demand for ultra-low freezers.

 

The demand for cold storage equipment has continued beyond the pandemic due to "an increased focus on mRNA therapeutics, which require ultra-low freezers for various steps in production," said Joe LaPorte, chief innovation officer of PHC Corporation of North America (PHCNA), stated in a recent Nature article. ^vii

 

The importance of the cold chain was well-established during the pandemic and entered mainstream conversations. Yet, for mRNA therapeutics, the thermosensitivity of mRNA could pose additional challenges. While mRNA vaccines use a small amount of protein production, "mRNA therapeutics require as much as a 1,000-fold-higher level of protein to reach a therapeutic threshold." ^viii It is, therefore, even more important for ULT freezers to have a field-proven track record of high performance.

 

ULT Performance is Paramount

 

The inability of an ultra-low temperature freezer to provide stable temperatures at designated setpoints risks compromising the efficacy of mRNA therapeutics, leading to ineffective treatments that could severely impact public health.

 

 

• History of Product Reliability, Longevity
• Temperature Uniformity
• Fast Temperature Recovering After Door Openings
• Energy Efficiency (Balanced with Overall Performance)

 

 

PHCbi Brand Cold Storage Solutions

PHCbi brand ultra-low temperature freezers are designed to meet or exceed the requirements necessary for the reliable, long-term storage of samples. They provide dependable performance over the range of -40°C to -86°C. Performance of all PHCbi -86°C freezers is measured by overall temperature, stability in high ambient settings, recovery following routine door openings, and reproducibility of internal conditions in real-world settings with most models ENERGY STAR® Certified.

 

 

ⁱ Centers for Disease Control and Prevention (CDC), "COVID-19 Vaccines Work," June 28, 2022, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/work.html.

ⁱⁱ Rohner, E., Yang, R., Foo, K.S. et al. Unlocking the promise of mRNA therapeutics. Nature Biotechnology. 40, 1586–1600 (2022). https://doi.org/10.1038/s41587-022-01491-z.

ⁱⁱⁱ Ibid.

^iv Mathur, Neha. “Beyond vaccines: emerging technologies capable of unlocking the promise of biologically targeted mRNA therapeutics.” November 7, 2022. News Medical. Reviewed by Danielle Ellis, B.Sc. https://www.news-medical.net/news/20221107/Beyond-vaccines-emerging-technologies-capable-of-unlocking-the-promise-of-biologically-targeted-mRNA-therapeutics.aspx

^v Rohner, E., Yang, R., Foo, K.S. et al. Unlocking the promise of mRNA therapeutics. Nature Biotechnology. 40, 1586–1600 (2022). https://doi.org/10.1038/s41587-022-01491-z.

^vi Kis Z. Stability Modelling of mRNA Vaccine Quality Based on Temperature Monitoring throughout the Distribution Chain. Pharmaceutics. 2022 Feb 17;14(2):430. doi: 10.3390/pharmaceutics14020430. PMID: 35214162; PMCID: PMC8877932. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8877932/

^vii Nature. “The cold chain innovates to meet post-COVID demands.” Nature Portfolio. November 2022. https://www.nature.com/articles/d42473-022-00227-6.

^viii Kis Z. Stability Modelling of mRNA Vaccine Quality Based on Temperature Monitoring throughout the Distribution Chain. Pharmaceutics. 2022 Feb 17;14(2):430. doi: 10.3390/pharmaceutics14020430. PMID: 35214162; PMCID: PMC8877932. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8877932/