Helping Cells Arrive Alive: From Passive Packaging To Rescue Design Packaging

By Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance at BioLife Solutions, Inc., USA

The packaging of time- and temperature-sensitive healthcare products has changed very little over the past quarter century. However, the advent of new, fragile cell therapies demands the need for greater temperature precision, and the ability to collect multiple data of environmental and handling conditions within the distribution environment through continuous real-time monitoring and on-line accessibility. This article explores the lessons learned from the decade-long tortuous path taken by the pharmaceutical and biopharmaceutical industries with regard to shipping environmentally fragile products and how it has led to the development of rescue design packaging capable of precision performance with flexible intervening capabilities during transit - so-called “smart” shipping containers. Embedded electronics provide monitoring and recording a host of data on a per-package basis. The data is managed through a proprietary and secure web-based application where the tracking, management and analytics of each package can be applied in a multitude of ways, from gaining greater understanding of a products’ stability in the distribution environment to choosing the best routes and modes of transport.