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

Published

February 8, 2021

Author(s)

Yihua B. Yu, Katharine T. Briggs, Marc B. Taraban, Robert Brinson, John Marino

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.

Citation

Pharmaceutical Research

Volume

38

Pub Type

Journals

Download Paper

https://doi.org/10.1007/s11095-021-03008-w

Local Download

Keywords

biologics, cold chain, drug products

Citation

Yu, Y. , Briggs, K. , Taraban, M. , Brinson, R. and Marino, J. (2021), Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics, Pharmaceutical Research, [online], https://doi.org/10.1007/s11095-021-03008-w, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=931571 (Accessed April 18, 2024)