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24 BioPharm International ® Emerging Therapies eBook September 2023 www.biopharminternational.com O ngoing innovation in the biopharma pipe- line continues to bring hope to patients and prescribers everywhere. Biologic mol- ecules, however, are inherently fragile and thus are susceptible to deterioration in the face of excursions from the refrigerated, frozen, and ul- tra-frozen temperatures that are required through- out every step in the storage and transit process. The universe of high-value biologics—which in- cludes 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 trans- port of not just extracted blood but extracted bone marrow, spinal f luid, 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 safe- guard these products as they move from manufacturer to patients for infusion in a clinical setting or self-in- jection at home has also continued to evolve in terms of improved shipping container designs and insulation materials and state-of-the-art tracking and monitor- ing devices. At the same time, stakeholders are grow- ing more comfortable using advanced data analytics capabilities (including artificial intelligence [AI] and machine learning [ML] techniques) and are pursuing strategic partnerships and geographically advanta- geous acquisitions to safeguard these critical time- and temperature-sensitive healthcare interventions. This ongoing expansion of both experience and ex- pertise comes at a good time, as the pipeline for CGTs and other personalized biologics continues to grow. For example, according to the Alliance for Regenera- tive Medicine, a dozen CGT products and gene-editing therapies are on track to be approved in 2023 in the United States and Europe (1). Protecting High-Value Biologics at Every Turn Suzanne Shelley is a contributing editor to BioPharm International. Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships. LEOWOLFERT - STOCK.ADOBE.COM