Filling the logistical gaps to support CGT clinical trials

There are hundreds of late-stage cell and gene therapy (CGT) clinical trials currently underway, and the number of approved treatments is expected to rise over the next few years. This makes it critical to have an established operational and logistics infrastructure to support these novel CGT therapies. But, clinical drug supply leaders have expressed poor confidence in their ability to supply clinical trials for CGTs, with only 9 percent confident that they can deliver rapid vein-to-vein times required for autologous cell therapies based on a 2021 survey by McKinsey.¹ 

While supply logistics for many clinical trials can be complex, CGT clinical trials introduce their own unique obstacles. In addition to the rigorous requirements for keeping biological materials viable, autologous CGTs require extensive coordination to retrieve samples from a patient, formulate the therapy, and return it to the correct patient. Here we review the key logistical challenges facing clinical drug supply leaders and how they may be mitigated in the future, including temperature control, time sensitivity, and visibility. 

Maintaining temperature control

To stay effective and safe, biologics have very specific temperature requirements that must be maintained at all times. For CGTs, these temperature requirements can reach as low the cryogenic range, or -185°C. Unsurprisingly, this means that transporting and storing CGTs takes specialized equipment and packaging, such as liquid nitrogen dewars and dry shippers.

One of the major challenges facing temperature control logistics is the need to establish an adequate infrastructure, such as sufficient temperature-controlled storage, shipping containers, and packaging. The COVID-19 pandemic saw some expansion of this infrastructure, as the need to transport and store large numbers of vaccines at controlled temperatures took priority worldwide. However, the infrastructural expansion needs to continue to support the growth of CGTs: Some estimate that the CGT market will expand at a 39 percent compound annual growth rate between 2022 and 2030.

Having reliable access to cryogenic or other temperature-controlled shipping and storage capabilities — such as through partnership with Yourway, a logistics provider experienced in temperature control — allows CGT clinical trials greater flexibility in selecting trial sites. Additionally, it secures a trial’s ability to ship a treatment for manufacture and receive it in a timely fashion. 

Time sensitivity

Timing is a critical element for CGT clinical trials. Often, biological materials, particularly in cases in which they are delivered fresh rather than cryogenically preserved, only remain viable for a limited period of time. Even when freshness is not as much of a concern, therapeutics need to be available for the established timeline of the clinical trial — especially because patients may be receiving immunosuppressants or other treatments in preparation for administration of a CGT, and delays may impact the patient’s health. What’s more, significant delays may lead shipping and storage containers to exceed the window in which their abilities to regulate temperature are effective.

As previously stated, having ready access to the necessary temperature-controlled shipping materials is one element to ensuring timeliness, as it precludes delays due to waiting for needed logistical components. Additionally, access to strategically placed cGMP (current good manufacturing practice) depots around the world can assist with timing — for example, if a CGT must be stored at any point in the process, the location of that storage facility can make a significant difference in the subsequent transport time to the destination. 

Another consideration is the navigation of regulations for international trials. Many governing bodies, such as in the United States and the European Union, have strict guidelines for the transport of CGTs. This means that any failures to prepare for regulatory requirements may lead to delays in transport at borders. Therefore, understanding and planning for regulations, as well as staying up to date on any changes, can be critical to timeliness.

Tracking, monitoring and visibility

Because of the many variables on which CGTs depend, such as temperature and timing, supply chain visibility is critical to clinical trial sponsors. Being able to track and monitor the status and location of a therapy is helpful to protecting its integrity, as well as coordinating elements of this complex supply chain. Through such tools as data loggers and internet-enabled sensors — which can be embedded into shipping containers to record and relay important status information such as temperature — trial sponsors can monitor their CGTs in real time. Such devices can even create alerts when there are issues, allowing problems to be mitigated in a timely manner.

One tool that has emerged to assist in the coordination of the many varied pieces of CGT transport and manufacture is the use of cell orchestration systems. These are digital platforms that help to arrange scheduling, conduct tracking, and even manage chain of custody and chain of identity. By bringing all such information into one place, visibility into the supply chain is improved, and it becomes easier to ensure that all details are accounted for.

Prepare for your CGT clinical trials

CGTs are likely to increase in prevalence and demand within the medical landscape. So, being prepared for clinical trials in this space will be critical in the future. Yourway, with its established expertise and experience in CGTs, helps to ensure that logistical hurdles do not present a barrier to your clinical trial’s success.

Learn more about Yourway’s CGT clinical trial supply chain management capabilities here, or by getting in touch at info@yourway.com.

Sources:

1. Clinical Supply Chains: How to Boost Excellence and Innovation | McKinsey
2. “Cell and Gene Therapy Market Size, Growth, Trends, Forecast Report 2022-2030.” BioSpace, https://www.biospace.com/article/cell-and-gene-therapy-market-size-growth-trends-forecast-report-2022-2030/. Accessed 5 Apr. 2024.