The cell and gene therapy (CGT) landscape is undergoing a significant transformation, spurred by substantial R&D investments and scientific breakthroughs. Allogeneic cell therapies, which involve using donor cells to treat multiple patients, are at the forefront of this evolution, now constituting 50% of Phase I cell therapy trials.
Advantages of Allogeneic Cell Therapies
Allogeneic cell therapies, often termed "off-the-shelf," present several advantages over autologous therapies, where a patient's own cells are modified and reintroduced. A key benefit is the capacity for efficient large-scale manufacturing. Unlike autologous therapies that require a patient-specific manufacturing process, allogeneic therapies can be produced in batches, potentially reducing time-to-treatment and expanding access to innovative therapies on a global scale. According to a Business Wire report, the global market for allogeneic cell therapies is projected to grow at a compounded annual growth rate of 14% from 2023 to 2035.
Logistics and Supply Chain Considerations
While autologous therapies necessitate managing two critical supply chains—from patient to manufacturer and back—allogeneic therapies introduce distinct logistical challenges. The supply chain begins with donor cell collection, followed by transport to the manufacturer for modification and subsequent shipment to a GMP-compliant storage facility. These products are then stored frozen for on-demand delivery. A single batch of engineered cells has the potential to treat hundreds of patients.
Like autologous cell therapies, allogeneic products are viable only within strict time and temperature ranges. Fresh cells may only remain viable for 12 to 96 hours before degradation occurs.
The Role of Cryogenic Logistics
Cryogenic storage techniques, which involve freezing cells at extremely low temperatures (below -150°C), can extend shelf life. Cryogenic transportation ensures the safe transport of these materials, preserving their integrity over long distances. However, specialized facilities to support cryogenic storage may not be available in all markets, particularly in remote locations.
As the number of allogeneic therapies in clinical development increases, so does the demand for cryogenic logistics infrastructure worldwide. A survey of CGT company leaders indicated that nearly 60% anticipate a significant increase in their need for cryogenic transportation and storage services through 2024.
Infrastructure and Technology Investments
Robust cryogenic logistics infrastructure, including facilities near processing centers and healthcare providers, is essential for scaling allogeneic agents and ensuring global access. Companies like World Courier have invested heavily in establishing a cryogenic cold chain that integrates transport and storage across all inhabited continents. These operations require real-time temperature and location monitoring, as well as advanced packaging solutions like dry shippers, which use nitrogen vapor to maintain temperatures between -150°C and -200°C for extended periods.
Effective handling of dry shippers requires trained personnel responsible for maintenance, inspection, and conditioning. As Andrea Zobel, PhD, Senior Director, Personalized, Supply Chain, World Courier, a part of Cencora, notes, "Continued investment in these facilities globally—and larger shipper solutions—will be critical to support efficient and timely shipments of these products."
Future Outlook
Following a record number of FDA approvals in 2023, the CGT market is poised for substantial growth. As the sector advances and the number of allogeneic cell therapies in late-stage clinical development rises, it is crucial to have the necessary infrastructure to support the unique time and temperature requirements of these products. Early planning and collaboration among healthcare stakeholders can help overcome logistical challenges and ensure that these therapies reach the patients who need them.
