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    Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics.

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    Author
    Yu, Yihua Bruce
    Briggs, Katharine T
    Taraban, Marc B
    Brinson, Robert G
    Marino, John P
    Date
    2021-02-08
    Journal
    Pharmaceutical Research
    Publisher
    Springer Nature
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1007/s11095-021-03008-w
    Abstract
    Biologics are complex pharmaceuticals that include formulated proteins, plasma products, vaccines, cell and gene therapy products, and biological tissues. These products are fragile and typically require cold chain for their delivery and storage. Delivering biologics, while maintaining the cold chain, whether standard (2°C to 8°C) or deepfreeze (as cold as -70°C), requires extensive infrastructure that is expensive to build and maintain. This poses a huge challenge to equitable healthcare delivery, especially during a global pandemic. Even when the infrastructure is in place, breaches of the cold chain are common. Such breaches may damage the product, making therapeutics and vaccines ineffective or even harmful. Rather than strengthening the cold chain through building more infrastructure and imposing more stringent guidelines, we suggest that money and effort are best spent on making the cold chain unnecessary for biologics delivery and storage. To meet this grand challenge in pharmaceutical research, we highlight areas where innovations are needed in the design, formulation and biomanufacturing of biologics, including point-of-care manufacturing and inspection. These technological innovations would rely on fundamental advances in our understanding of biomolecules and cells. © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.
    Keyword
    COVID-19
    biologics
    cold chain
    vaccine
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/14759
    ae974a485f413a2113503eed53cd6c53
    10.1007/s11095-021-03008-w
    Scopus Count
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    UMB Open Access Articles
    UMB Coronavirus Publications

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