Article: Delivering a Cost Effective, Practical and Robust Cell Therapy Supply Chain
By Bruce McCormick; Simon Ellison |
will likely prove 2017 to be the beginning of the new era of medical treatments
using cell and gene therapies. The FDA approval of Novartis’ Kymriah and Kite’s
Yescarta CAR-T therapies represent therapeutic promise not even dreamed of 15 years
The fantastic accomplishments and promise of these new therapies brings with them another wave of logistical challenges relating to the supply and delivery of materials, especially when frozen. The traditional cold chain model used by the pharmaceutical industry is not viable for the successful transition into cell and gene therapies (CGT). No longer will a manufacturer be able to validate a package, shipping lane and stick a label on a package to ship it out.
Each and every cell and gene therapy is a unique and often irreplaceable product. The cost to produce these products is high and the value to the patient is critical. The supply chain of both inbound donation, for autologous, material and outbound manufactured therapy is a critical component to the successful growth of these life changing therapies.
Technology for efficiency and cost improvements
The new era of CGT will show the increased reliance on specialty couriers, not just for clinical trials but for commercial distribution too, as a result of the advanced services they offer to ensure safe delivery of these critical materials.
the industry to continue delivering commercially viable therapies, it needs to
optimize the shipping container by reducing weight, and therefore cost, as well
as adding tracking technology to better control shipments.
The ability to provide real time information regarding a shipment’s condition, location, and chain of custody is a critical service feature. Being able to integrate this data into a manufacturer’s data system is another feature that will further streamline and enhance safety, improve efficiency and in time, lower the costs of production.
A new age of dry vapor shippersCosts are always a critical factor with any product and one additional way World Courier is helping CGT customers is with the use of smaller sized dry vapor shippers that can cut the cost of delivery in half over traditional DV shippers. Furthermore these smaller shippers are much easier to handle in the field. As simple as this may sound it is truly a critical factor in helping CGT products grow in use. If you have ever tried to move a standard dry vapor dewar around you know that a recipient hospital is not going to be able to handle many of these on any given day. The DV4 shipper used by World Courier can be easily carried by a single nurse.
Finally these new therapies are requiring chain of custody and chain of identity which require the expert attention of logistics specialist such as World Courier. This expertise coupled with smart shipping containers which provide real time condition reporting are essential services for the success and advancement of these promising new therapies.