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Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.
Ongoing innovation in the biopharma pipeline continues to bring hope to patients and prescribers everywhere. Biologic molecules, however, are inherently fragile and thus are susceptible to deterioration in the face of excursions from the refrigerated, frozen, and ultra-frozen temperatures that are required throughout every step in the storage and transit process.
The universe of high-value biologics—which includes injectable specialty medications, cell and gene therapies (CGT), and other regenerative medicines and more—has come a long way over the past decade. Further complicating the picture, a growing number of innovative CGTs and other regenerative therapies call for the highly specialized collection and transport of not just extracted blood but extracted bone marrow, spinal fluid, and other tissue types, which are then used to produce engineered therapies that are used to repair, replace, or regenerate organs, cells, and metabolic processes in the body.
The cold chain infrastructure that is needed to safeguard these products as they move from manufacturer to patients for infusion in a clinical setting or self-injection at home has also continued to evolve in terms of improved shipping container designs and insulation materials and state-of-the-art tracking and monitoring devices. At the same time, stakeholders are growing more comfortable using advanced data analytics capabilities (including artificial intelligence [AI] and machine learning [ML] techniques) and are pursuing strategic partnerships and geographically advantageous acquisitions to safeguard these critical time- and temperature-sensitive healthcare interventions.
Editor's Note: This article was previously published online July 12, 2023.
Suzanne Shelley is a contributing editor to BioPharm International.
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When referring to this article, please cite it as Shelley, S. Protecting High-Value Biologics at Every Turn. BioPharm International Emerging Therapies eBook. September 2023.