April 15, 2022

Fundamentals of Autologous and Allogeneic Cold Chain Management

Know the pressures, risks, and opportunities in the CAR T -cell and gene therapy cold chain

Autologous and allogeneic therapies are forcing companies to rethink their cold supply chain strategies. What applies to the traditional pharmaceutical cold chain does not apply for cell and gene therapy cold chains.

The degrees of complexity with managing vein-to-vein delivery models and the personalization of medication mean companies need to plan and over strategize for every potential risk and disruption possible. The stakes are too high to take chances or assume that tried-and-true strategies, packaging, and knowledge apply.

Autologous cell therapies use a patient’s own cells, demanding precise logistics and cold chain management to ensure meticulous timing and delivery. While allogeneic therapies do not have the same level of personalization as autologous therapies, the challenges are based in the very nature of allogeneic therapies – a geographically diverse map of product inventory, distribution networks, and patient locations.

In this article we highlight the cold chain demands and risks of both autologous and allogeneic therapies, and how these require a more flexible and dynamic cold chain management process.

Vein-to-vein delivery, personalized medicine, and cryogenic cold chains are no longer the stuff of the future – they are here. From the initial patient visit to secondary cold chain packaging through to therapeutic delivery to one patient or multiple patients – every step of the CAR T cold chain needs to be repeatable, flexible, and predictable. And no, this is not a contradiction – it’s the cold chain of today and the future.

The CAR T -Cell and Gene Therapy Industry in Numbers

CAR T -cell and gene therapy is revolutionizing cancer and other disease therapies and treatments. We are seeing a worldwide boom in companies, funding, and partnerships focused on autologous and allogeneic therapy research, manufacturing, and delivery.

These statistics and notable dates in the history of CAR T -cell and gene therapy underscore the pace of change and industry pressures:

  • 2017: first U.S. FDA approval of CAR T -cell therapy
  • 6: FDA approved CAR T -cell therapies since 2017
  • $4.99 billion US: 2021 valuation of the cell and gene therapy market size
  • $36.92 billion US: 2027 predicted growth of the cell and gene therapy market
  • 10 – 20 products per year: anticipated FDA approval rate of CAR T -cell therapies by 2025
  • 103% increase: in European financing of cell gene therapies in 2020 compared to previous years
  • $35 billion US: biopharma industry annual loss due to temperature excursions and logistics
  • 1,000: cell and gene therapy trials underway globally

To support this growth in medical research and innovation, other industries must keep pace. Proven, secure, and precise manufacturing, packaging, shipping, and delivery of CAR T -cell and gene therapies will determine the success, affordability, and future of these medical breakthroughs.

Autologous and Allogeneic Cold Chain Pressures

At first glance, the vein-to-vein delivery model of autologous therapies mandates higher logistical and supply chain demands than allogeneic therapies.

However, the distributed nature of allogeneic therapies places equally demanding pressures on everyone involved in the manufacturing, packaging, shipping, and delivery of these therapies.

Autologous Therapy Logistics/Cold Chain Pressures Allogeneic Therapy Logistics/Cold Chain Pressures
Personalized to one patient Multiple patient locations and care sites
Limited access to doses Geographic disparity of clinical trials, manufacturing, inventory, patients, and companies
Health status of the patient Health status of the patient
Chain of identity and chain of custody imperatives Wide distribution network creates additional cold chain risks and gaps
Precise and efficient collection from the patient through to expedited manufacturing and delivery back to the patient Lack of nationwide (and global) standards and regulations for distribution and licensing

Core logistic and cold chain pressures for both autologous and allogeneic therapies:

Time: the longevity of CAR T -cell and gene therapies is limited, demanding companies have a streamlined yet flexible cold chain strategy from cell harvesting through to patient delivery.

Temperature: there is no room for error or variation in the temperature management and security of these therapies. Temperature excursions result in dollar and life costs.

Human risk: ensuring the people handling CAR T -cell and gene therapies have the skills, training, and infrastructure to withstand cold chain risks including weather delays, labor shortages, paperwork errors, packaging and labelling standards, and more.

Distribution channels: both autologous and allogeneic therapies demand precise coordination across multiple distribution partners and channels. Relying on one distribution strategy is not enough.

Global stability and supply chain variables: there are no guarantees that ports are open, people are available, or that the small number of manufacturing and distribution sites and experts can operate as expected. Consider the impacts of the COVID-19 pandemic and the trickle-down effects of the Russian attack on Ukraine.

Limited inventory with high patient demand: the availability of CAR T -cell and gene therapies and the health status of the people who need these therapies means there is no room for delays or interruptions in last mile delivery.

Cost of manufacturing, delivery, and patient care: cost is at a premium, whether it’s the cost of manufacturing, the cost of moving these products through the cold chain, or the patient care costs of harvesting and delivering these therapies.

Speed of delivery: the very nature of the CAR T -cell and gene therapies puts a premium on innovative and flexible JIT cold chain management

End-to-end visibility and traceability: real-time visibility and status updates through every phase of the product lifecycle is a requirement. From knowing when a patient is arriving for cell harvesting to tracking when the product was packaged and left the manufacturing site to confirmation of the ultimate delivery to the patient or patients – every step must be traced and monitored.

Regulations, paperwork, and customs and border clearance: errors in paperwork, a lack of knowledge of state-by-state regulations, labelling inconsistencies, or delays in customs and border clearance cannot happen.

The personalized medicine model of autologous therapies and the distributed nature of allogeneic therapies require companies to recognize the opportunity within these pressures.

And then proactively optimize their cold chain best practices to take advantage of the latest in packaging, technology, and communication to create a flexible yet consistently repeatable and predictable cold chain process.

Evaluating CAR T -Cell and Gene Therapy Cold Chain Packaging

Just as there have been advances in CAR T -cell and gene therapy since the initial FDA approval in 2017, the cold chain packaging industry is experiencing equally accelerated growth.

This is good news for companies involved in all aspects of human health sciences, research, manufacturing, logistics, and on-site care.

Leading CAR T -cell and gene therapy secondary packaging technologies and options:

  • Smart packaging: gives real-time monitoring, traceability, and end-to-end visibility of products through the cold chain to provide updates on location, temperature status, product status (orientation, drops, falls, shock, or other damage), estimated time to delivery, weather, and transport delays or contingencies.
  • Phase change materials (PCM): these packaging materials are designed to freeze or melt at or near the same temperature as the products they are protecting. These PCM products are designed to be flexible and reactive to temperature variations, proving to be essential to minimizing temperature excursions on a package-by-package basis.
  • Bluetooth and IoT sensors: enable proactive GPS monitoring with geofenced alarms and notifications on multiple variables including temperature, location, and delivery status – ensuring the right people are available at the right times to deliver and receive CAR T -cell and gene therapies to patients.
  • Cryogenic packaging, pallets, and freezers: supports the longer-term storage of cells, increasing the shelf-life and the availability of cell and gene therapy products. While time is still of the essence, these cryogenic options provide scientific, medical, and practical benefits for researchers, shippers, and patients.

It is important to remember that even the latest in digital data trail technologies and supply chain control tower logistics infrastructure cannot withstand the poor execution of cold chain management best practices.

Questions to Ask About Your CAR T Cold Chain Management Practices

Whether you’re new to CAR T cold chain management or having existing processes in place, you must always be looking for ways to streamline, strengthen, and refine your cold chain processes.

Keep in mind these key questions when evaluating or troubleshooting your CAR T cold chain management process:

Where are our supply and logistics partners located? What are the risks and opportunities for us with these locations? Where are our patients (clients) located?

What levels of training and education do our people have? What types of education and training do we need from our partners to ensure the timely and secure shipping, packaging, and distribution of our cell and gene therapy products?

Are we using the latest in packaging technologies and options? Why or why not? How confident are we in our cold chain packaging?

What are our time constraints and how does this impact our cold chain strategy

Is our cold chain strategy flexible enough to absorb risks such as weather, labor shortages, global instability, or human error? Is our cold chain strategy predictable and repeatable?

How can JIT help us better meet the needs of our patients and partners? What are our logistics and inventory management gaps?

What can we do better? What are we doing right? What can we learn from our competitors and partners?

For any company involved in autologous and allogeneic cell and gene therapies – time is of the essence.

Whether you’re a health sciences company developing a new autologous therapy, operating a healthcare delivery site for CAR T -cell and gene therapy patients, a 3PL specializing in cold chain management, or you’re tasked with managing the cold supply chain for cell and gene therapy products – there is no time to waste.

You need to know you have immediate access to right people, processes, data, tools, and technologies to fulfill your role in delivering potentially life-changing therapies to the people who need them now.

At Cold Chain Tech, we are experts in packaging for CAR T -cell and gene therapies, vaccines, and other pharmaceuticals. This is what we do. And we are here to help you do what you do best.

Contact us to discuss CAR T -cell and gene therapy cold chain best practices, strategies, packaging, and technology. Sign up for Cold Chain Tech blog updates to learn how are team helps you maintain the integrity, safety, and quality of your autologous and allogeneic products.

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About Heather Hargraves
Heather Hargraves is a results-driven marketing communications professional with over 15 years of experience creating content for business needs using diverse skill sets. She is an expert at implementing highly effective programs using lead generation tactics, copywriting, integrated marketing campaigns, webcasts, social media, and more.

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