Our global advanced therapy medical product charging stations and capabilities
By Andrea Zobel
The healthcare landscape is witnessing transformative growth with the advancement of cell and gene therapies (CGTs). With an expanding development pipeline and an increasing number of approvals, these breakthrough therapies are heralding new hope for patients across the globe. However, this rapid growth also presents unique challenges, particularly in logistics and delivery. The burgeoning CGT field underscores the importance of efficient cryogenic shipping solutions in supporting this vital industry.
In this article we will explore:
- The key stats of the gradually expanding CGT development pipeline
- Recent market approvals
- The necessity of a global network of liquid nitrogen recharging stations to support industry growth
CGT pipeline key insights for 2023 Q4:
What cell and gene therapies were approved in 2023?
Globally, the number of approved gene, cell, and RNA therapies continues to grow at a steady pace. As of the final quarter of 2023, the medical field witnessed significant progress with several approvals. In total, 30 gene therapies, which also includes genetically modified cell therapies are now on the market. In the U.S., Casgevy was approved for treating sickle cell disease and in the UK for both sickle cell disease and a type of thalassemia. Inaticabtagene autoleucel received approval in China for acute lymphocytic leukemia, while Lyfgenia got the green light in the U.S. for treatment of sickle cell disease.
Furthermore, 29 RNA therapies have been given the go-ahead to date. Wainua was approved in the U.S. for a specific type of amyloidosis, while Rivfloza was approved for hyperoxaluria. Finally, SYS-6006.32 was granted emergency use in China as a prophylaxis against COVID-19 further broadening therapeutic options available to patients worldwide.
There were no new cell therapy approvals during this the last quarter, with the total of non-genetically modified cell therapies receiving approval remaining at 65.
How many cell and gene therapies are in development?
During 2023 Q4, the development pipeline continued to expand. Total CGTs in development grew from 3,866 at the end of Q3 to 3,951. This can be broken down into the following:
- 2,111 gene therapies
- 878 non-genetically modified cell therapies
- 962 RNA therapies
World Courier’s role in advancing therapy medicinal products
To support the growth of the advanced therapy medicinal product (ATMP) industry and enable more patients than ever before to be treated with these life-changing therapies, World Courier utilizes its global network of liquid nitrogen (LN2) charging centers and stations.
This network is built on World Courier’s existing infrastructure, leveraging our company-owned LN2 charging centers (office or depot locations) or vetted vendors’ charging stations. This means that ATMP developers can immediately benefit from an established and qualified operation with access to cryogenic shipping solutions close to patient and manufacturing locations.
Our LN2 charging capabilities
Our global in-house and third-party LN2 charging capabilities provide convenient and reliable solutions for your cryogenic shipments. We can also tailor a custom solution to fit your unique needs and requirements, no matter where you are shipping from or to. Regions not covered: Cuba, Iran, Syria, Eastern Ukraine, Crimea, North Korea.
Our network capabilities enable access to a range of cryogenic shippers with shorter lead times and reduced positioning costs
One of the challenges within the ATMP industry is the delivery of critical shipments, such as aphaeresis donations and final therapies. The short shelf life of fresh shipments and the resulting logistics complexity may encourage therapy developers to qualify cryopreserved transport. To enable this solution, dry shippers need to be charged with LN2 by fully trained staff for both the LN2 discharge and the processes for filling the dewar(s) This is a specialized process, in which dry shippers must be:
- Inspected and cleaned prior to use
- Fully charged, with supporting documentation
- Positioned when and where required in readiness for these highly critical therapies
Only after those stringent steps have been taken can the critical shipment take place. These preparations take time, especially when a charging center or station may be located in another country from the clinic or manufacturing site.
Supporting the growing pipeline
Data shows there are over 1,350 therapy developers globally. To support this growth, World Courier has a fleet of cryogenic dry shippers, as well as the ability to charge and ship customers’ units throughout its global network of strategically located owned charging stations and vetted vendors’ charging stations to offer near-total global coverage.
The strategic intention is to leverage a network of owned and qualified vendor charging stations as well as unit suppliers to develop unmatched worldwide coverage as globalization of cryogenic services continues. By utilizing its global network, World Courier helps advanced therapy companies build robust logistics platforms that support the clinical development and commercialization of therapies to meet patient treatment needs.