Research & Development (R&D) is actively being pursued in regenerative medicine using iPS, ES, and mesenchymal stem cells, pushing up the need for cryogenic shipping of biological specimens and samples, according to The Gas Review.
To ship at -150°C or less requires liquid nitrogen (N2) and cryopreservation containers, but current shipping quantities are too small to create markets of any size. However, the pharmaceutical industry is about to enter the age of the revolutionary change from low-molecular pharmaceuticals to bio-pharmaceuticals, and distribution of regenerative medical products is set to most surely increase in the near future. This has drawn a lot of interest in cryogenic shipping not only from industrial gas companies, but also from distributors.
What’s more, the rapid increase in demand for dry shippers, one type of cryopreservation containers, cannot be overlooked. There is no doubt that regenerative medicine will increase the demand for carbon dioxide gas and nitrogen to cultivate and store cells, but it seems that it will be cryogenic shipping using dry shippers that will drive this young market.
Liquid N2 feeder installed at distribution centres
Many other companies are also entering cryogenic shipping with dry shippers. Medipal Holdings, Mitsui Soko Holdings, Trust Express, Cryoport, and CryoSend are developing business.
Of these, Medipal Holdings undertakes all shipping for the regenerative medicine product TEMCELL HS Injection of JCR Pharmaceuticals. The active ingredient of this product is allogenic biological cells. It is currently the only regenerative medication that requires cryogenic shipping.
According to documents released by Medipal Holdings, Medipal Holdings has built an “ultra-low cold chain system” to deliver their product anywhere in Japan. This system uses eight distribution transfer centres located all over Japan along with an ultra-low temperatures storage and transport cart that they developed in-house.
This pushcart contains a vacuum-insulated container that can store the product under the gas phase of liquid nitrogen. It is assumed that the built-in container is a dry shipper. The carts are used to transport the medication from the distribution centres to medical institutes.
Also, the distribution centres are equipped with liquid nitrogen supply systems. The systems are used to fill the carts with liquid nitrogen. According to a photo released by the company, a supply system consists of three 100-litre class LGCs and an automatic supply device. The system is very simple, but it is thought that one system would require an investment of at least several million yen.
Incidentally, TEMCELL HS Injection is administered to around 500 patients annually, and is classified as a rare disease medication. In order to strictly control the temperature during cryogenic shipping, the above systems are required at the distribution centres.
On the other hand, Mitsui Soko Holdings has been implementing a shipping service for iPS cells for regenerative medicine since 2015. According to a news release, they developed a special container at the request of the Centre for iPS Cell Research and Application, Kyoto University (CiRA), and started cryogenic shipping. This container was named “MEDi STAR.” Details are not available, but the news release says “it is filled with liquid nitrogen to maintain a temperature of -180 degrees and is designed to reduce vibration.” This container is therefore also thought to be a dry shipper.
In August of this year, Mitsubishi Logistics installed cryogenic bank facilities consisting of liquid nitrogen tanks and medical freezers at the Life Innovation Centre in Kawasaki, Kanagawa Prefecture. They are undertaking storage of frozen cells and are also developing shipping business with dry shippers.
In other moves, Trust Express seems to be accepting cryogenic shipping work in the same way as Wanbishi Archives and Saroute from pharmaceutical companies and research institutes. Cryoport has been undertaking cryogenic shipping for the FedEx Group, and is said to have a lot of experience with international air shipments.
Details of CryoSend’s business in Japan are not yet known, but according to information provided on the internet, they are undertaking cryogenic shipping of germ cells such as eggs and sperm worldwide and have already completed more than 300 shipments. It appears that they are using dry shippers made by US International Cryogenics.
Regenerative medicine approval signals market expansion
There are currently for regenerative medical products that have been approved: JACE and JACC from Japan Tissue Engineering, TEMCELL HS Injection from JCR Pharmaceuticals and Heart Sheet from Terumo. TEMCELL HS Injection is the only one that requires cryogenic shipping.
However, it is possible that other rengenerative medical products that have biological cells themselves as the active ingredient, like TEMCELL HS Injection, will be approved. Medipal has prepared liquid nitrogen supply systems and 52 transportation carts around Japan to provide 500 rare disease patients with medication, but if the next regenerative medication that is approved is for general treatment, then a demand for liquid nitrogen, nitrogen supply systems, and dry shippers will appear at a much larger scale.
No product has yet to be approved this year, but according to someone related to pharmaceuticals at the Yokohama expo, “it appears that a drug that uses living cells will be approved this year.” Approval of regenerative medical products will stir the interest of not only medical personnel, but also people in distribution and industrial gases.
The Gas Review, issue no 444