In 1935 Erwin Schrödinger devised a thought experiment in which he described a paradox of quantum mechanics. A cat was sealed in a box with a flask of poison, a source of radiation and a radiation detector. The flask of poison was linked to the radiation detector and would break if the monitor detected radioactivity. Although the half-life of the radioactive material was known, the precise moment that the radioactive energy was released and the cat became an ex-cat could not be determined in advance. Thus, as long as the box was sealed the cat could be simultaneously alive and dead. Only when the box was opened could the fate of the cat be observed.
Cell therapy products typically are more challenging to ship that traditional pharmaceutical products, you are after all shipping living cells (perhaps a little less challenging than a cat with a flask of poison). Even with robust mitigation strategies temperature excursions do occur; using conventional temperature monitors the manufacturing centre/treatment centre will only discover if there has been a temperature excursion once the shipment of starting material or therapeutic agent has been delivered to its final destination and the shipper opened; similar to the fate of Schrödinger’s cat, so while cell therapies are in transit one could assume that they are both within and outside their shipping specification.
TrakCel has integrated with temperature monitors that can provide real-time data and by configuring TrakCel’s platform warnings and alerts can be received should shipping temperatures exceed pre-set parameters. However, to effectively use real-time data, strategies need to be formed for addressing temperature warnings during shipments to prevent temperature excursions. Real-time data is of great value when shipping therapeutic agents (and starting material) from patients who may only have one chance of treatment or if collecting starting material is an invasive procedure which a patient may not want to repeat.
It is pointless to use these real-time monitors if you are unable to obtain access to the shipment in transit. To effectively use real-time data the following needs to be considered:
· If access to the shipment is possible how will the current custodian be notified should a temperature warning be issued?
· What can be done, or what equipment is required to return the shipment to the desired temperature at each step of the journey?
· What resources are required to continuously monitor the shipment?
Real-time monitoring can be an effective tool for ensuring that medical supplies arrive within specification. However, the resources and planning required currently preclude this technology from being used for low value shipments; real-time monitoring technology may be suitable for high value products and challenging supply chain models.
No cats were harmed during the writing of this blog.
Article by Dr Matthew Lakelin - 2 Nov 2016
Matthew is a co-founder of TrakCel. Using his knowledge in handling and distribution of CGTs he has assisted with the development of the technology platform, writing user-stories for GMP critical functions. Matthew provides a technical bridge between the software development side of the technology platform and the GxP application of the system.