NOTEWORTHY

Shifts in Supply Chains

COVID vaccines are being developed at unprecedented speed, with 38 vaccine candidates in clinical development and 149 in pre-clinical stages, according to the World Health Organization.

COVID vaccines could fail to reach broad patient populations due to logistical and commercial challenges. The logistics behind storing and distributing emerging COVID vaccines is an easily missed but crucial detail in the global medicine supply chain. The low temperatures needed to ship certain types of vaccines and cellbased therapies are beyond the capabilities of more traditional methods. The normal variability of temperature swings during shipment is a limiting factor. Safely and effectively distributing these medicines will require a new ecosystem of tools and services.

Two leading COVID vaccine candidates from Pfizer (and partner BioNTech SE) and Moderna Inc. rely on genebased technology called mRNA. These mRNA vaccines will face logistical challenges as they must be stored at subzero temperatures of nearly minus 80 degrees Celsius (minus 112 Fahrenheit). If they become too warm, they become ineffective.

Given the gene-based approach of many vaccine candidates, there will be growing demand for cold-chain logistics related to COVID. It will be important to move vaccines safely and store them appropriately, during clinical trials and once available to the public. Variances in temperature not only can render vaccines ineffective, but also can introduce liability issues if conditions and samples are compromised, making chain-of-compliance tracking technology critical.

Looking beyond COVID, the total addressable market for cryogenic shipping and cold-chain logistics is poised for multi-year growth as most cell- and gene-based therapies are shipped at ultra-cold temperatures.

Cell and gene therapies lay the groundwork for a future of personalized medicine with treatments that can address root causes of disease and illness. Treating and even curing the previously untreatable and incurable diseases is now a possibility.

We foresee broad growth of personalized and genomic medicine in the decade ahead. This chart illustrates the expected FDA approvals of new therapies requiring cryogenic shipping.

Use of conventional shipping methods is no longer suitable for newer cell- and gene-based therapies. With dry ice, for example, temperatures only average -80º Celsius with standard deviation up to 14 degrees. Samples used to develop CAR-T therapies must be kept below -136° Celsius and within a stable range of 2 to 8 degrees.

At Chevy Chase Trust, we are investing in the future of medicine, including the logistics of new distribution systems.