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. 2022 Mar 17;11(2):107-113.
doi: 10.1093/stcltm/szab025.

Shipping and Logistics Considerations for Regenerative Medicine Therapies

Tracy Criswell  1 , Corné Swart  2 , Jana Stoudemire  3 , Kelvin Brockbank  4 , Michael Floren  5 , Shannon Eaker  6 , Joshua Hunsberger  7
Affiliations

Shipping and Logistics Considerations for Regenerative Medicine Therapies

Tracy Criswell et al. Stem Cells Transl Med. .

Abstract

Advances in regenerative medicine manufacturing continue to be a priority for achieving the full commercial potential of important breakthrough therapies. Equally important will be the establishment of distribution chains that support the transport of live cells and engineered tissues and organs resulting from these advanced biomanufacturing processes. The importance of a well-managed distribution chain for products requiring specialized handling procedures was highlighted during the COVID-19 pandemic and serves as a reminder of the critical role of logistics and distribution in the success of breakthrough therapies. This perspective article will provide insight into current practices and future considerations for creating global distribution chains that facilitate the successful deployment of regenerative medicine therapies to the vast number of patients that would benefit from them worldwide.

Keywords: distribution; manufacturing; regenerative medicine; shipping and logistics.

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Figures

Graphical Abstract
Graphical Abstract
The establishment of distribution chains that support the transport of live cells and engineered tissues and organs is necessary for the dissemination of tissue-engineered products to patients worldwide. This perspective article provides insight into current practices and future considerations for creating global distribution chains, including current best practices for maintaining cell/tissue viability and the FDA codes that regulate these processes.
Figure 1.
Figure 1.
Current preservation and transport strategies. Certain cells, tissues, and organs can survive for hours to days when stored and transported at temperatures above freezing. Living cells and tissues must be kept at sub-zero temperatures in order to ensure long-term viability.
See this image and copyright information in PMC

References

    1. FDA authorizes Pfizer-BioNTech COVID-19 vaccine. Med Lett Drugs Ther. 2021;63(1615):1–2. - PubMed
    1. FDA authorizes Moderna COVID-19 vaccine. Med Lett Drugs Ther. 2021;63(1616):9–10. - PubMed
    1. U.S. Food and Drug Administration. J&J COVID-19 vaccine: emergency use authorization. Published Feb 27, 2021. Accessed July 18, 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-dise...
    1. Centers for Disease Control and Prevention. Pfizer-BioNTech COVID-19 vaccine: storage and handling. Published 2021. Accessed July 18, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/s...
    1. Centers for Disease Control and Prevention. Moderna COVID-19 vaccine: storage and handling. Published 2021. Accessed July 18, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/...