Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.
Two of the field’s most valuable luminaries representing both academia and industry — Dr. Bruce Levine and Simon Ellison, ISCT Commercialization Committee — discuss determining how CMOs can and should successfully manage cell and gene therapy supply chains.
This video demonstrates how the VIA Thaw CB1000 can standardize a critical step in the delivery of cell therapies with a simple, reproducible and traceable process for recovering cryopreserved samples in cryobags.
A video introduction on the VIA Freeze™ range which are liquid nitrogen-free controlled-rate freezers to cryopreserve any type of samples.
In today’s breakthrough medicines, personalization changes everything. Patients are used to receiving medications. Now, in the era of cell and gene therapies, patients are actually providing the key components to create them.
The temperature-sensitivity of cell and gene therapies, their personalized nature, and their circular (“vein-to-vein”) supply chain make maintaining a seamless supply chain critical; however, it is not easily achieved.
With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.
Orchestrating a modern cell and gene therapy supply chain involves enormous complexity. As a result, simplicity and standardization — in effect, plug and play — is demanded by the industry, especially for IT systems that track and guide personalized therapies from collection to infusion.
Aside from the clinical opportunity that gene therapy products present; they do introduce tremendous complexity into both the manufacturing and commercial processes. Remember these three points before developing your gene therapy plan.
Looking back at the hurricane season from the perspective of supply chain risk — and specifically risks that have impacted the life sciences supply chain — there are many lessons to be learned.