Delivering advanced CGT biologic breakthroughs to the world
By Andrea Zobel
Study offers insights into cell and gene therapy’s cryogenic cold-chains
Forty years ago, the first biopharmaceutical was introduced, which required refrigerated logistics. We are now entering a new phase in the evolution of pharmaceuticals - advanced therapies consisting of cells, tissues, genetically modified nucleic acids, or viruses with cryogenic or fast logistics requirements.
Cell and gene therapies (CGTs) represent a sea change in how pharma treats disease and cancer, immune and genetic disorders, and are attracting enormous investment across the biopharmaceutical industry. However, many of these therapies come with multi-faceted, cryogenic logistic requirements that add complexity and risk to an already uniquely complex manufacturing supply chain.
These therapies are available to patients only through logistics infrastructures with the technical and organizational capabilities to support them. In developing these new medicines, the logistics must adapt to the science, and not the other way around.
Because of our leading role in the industry's growth, World Courier wanted to explore the complexities associated with CGT development logistics and the kind of strategic relationships the industry wants (and must have) from third-party logistics (3PL) suppliers to be successful. We commissioned Coleman Parkes Research to survey executives and managers in supply chain operational roles within companies with CGTs in clinical trials or approved for patients and on the market.
CGTs need cryogenic logistics and an experienced 3PL
As an early innovator, World Courier has pioneered cold-chain logistics solutions for the biopharmaceutical industry. As the pace of our investment and development increased, it was clear more insight was needed to understand the logistical needs of this exciting and advanced area of biologics development, especially in this post-pandemic world.
Cell and gene therapy cryogenic logistics needs set to grow at an increasing pace
3,649* Cell and gene therapies (including genetically modified cell therapies, such as CAR-T cell therapies) were in development from preclinical through pre-registration at the end of 2022. According to CGT companies, trials and therapies won’t advance without third-party logistics partners providing a global network of cryogenic capabilities.*Source: https://asgct.org/global/documents/asgct-citeline-q3-2022-report.aspx
Cryogenic preservation’s role in CGT logistics is essential
59 percent of sponsors with CGTs in clinical trial indicated their need for third-party logistics partners with global cryogenic capabilities will grow significantly. Because CGTs are derived from either a donor(s) or the patient’s own cells and injected or infused into the bloodstream, both sterility and cell viability must be sustained. What makes these cell-based treatment supply chains unique is that they are closed-loop, non-linear, and often require cryopreservation. Both types have development and production cycles that must be established early in clinical trials.
COVID-19 pandemic highlighted new challenges for commercializing CGT products
96 percent of companies in clinical trials and 85 percent with commercial products found the pandemic highlighted both physical and technical issues. Pandemic also highlighted the need for both dedicated networks and partner capabilities to mitigate supply chain risk.
Spending on cryogenic logistics to accelerate
100 percent of CGT developers said they plan to accelerate spending in the next 12 months with third-party logistics partners with comprehensive global cryogenic capabilities.
To freeze, or not to freeze?
The patient’s or donor’s direct involvement as well as the preserving, processing and trans-shipment involved in autologous and allogeneic cell-based therapeutics demands a highly specialized and choreographed logistical approach. Whether the cells are transported fresh or frozen will depend on their unique needs.
World Courier has the full-service logistics and cryogenic storage solutions you need to seamlessly deliver CGT innovation
Committed and listening to the industry, we continue and expand our CGT capabilities to respond to new therapies. Across our global network of dedicated team members, we monitor the safety and integrity of your product proactively, ensuring it reaches patients without delay.
Leveraging our global capabilities and local, on-the-ground knowledge to navigate logistics complexities, World Courier can help create the cryogenic supply chain needed to bring breakthroughs to patients reliably and at the potentially life-changing pace they need.
