Shipping and Logistics Considerations for Regenerative Medicine Therapies

Abstract

Advances in regenerative medicine manufacturing continue to be a priority for achieving the full commercial potential of important breakthrough therapies. Equally important will be the establishment of distribution chains that support the transport of live cells and engineered tissues and organs resulting from these advanced biomanufacturing processes. The importance of a well-managed distribution chain for products requiring specialized handling procedures was highlighted during the COVID-19 pandemic and serves as a reminder of the critical role of logistics and distribution in the success of breakthrough therapies. This perspective article will provide insight into current practices and future considerations for creating global distribution chains that facilitate the successful deployment of regenerative medicine therapies to the vast number of patients that would benefit from them worldwide.

Freezing Biological Time: A Modern Perspective on Organ Preservation

“…Normothermic organ storage under physiological conditions has gained a lot of clinical and commercial focus in device development but suffers from very high costs compared with hypothermic alternatives. However, transport of living cells, tissue cultures, organs on chips, and bioengineered tissues under warm physiological conditions is becoming more common 8 , and we anticipate that normothermic perfusion will become more important with time particularly as a means of assessing organs prior to transplantation in combination with the low-temperature storage strategies discussed in the following sections. Normothermic liver preservation by perfusion can lead to the expansion of the liver donor pool by increased use of livers from donors after cardiac death compared with traditional static cold liver storage 9 , 10 .…”