In the Land of the Living Logistics
Ideal drug manufacturing and logistic processes are closed and automated to eliminate the risks associated with human intervention and manual operations, but most cell and gene therapies are not yet at this stage. Here, we discuss the problems of handling living, breathing cells in transit, and ask a big question: are healthcare systems ready for cell and gene therapies?
James Strachan |
In The Medicine Maker, we often discuss the challenges of scaling up and commercializing biologic drugs, such as monoclonal antibodies. Identifying the right set of conditions to get the highest titer possible, while ensuring there’s enough “wiggle room” should anything deviate, isn’t easy. But at least the cells are, in theory, identical, and there are established precedents to build processes upon. Cell and gene therapies are a whole new kettle of fish: every process is different because the cells are different, and companies are often inventing processes from scratch.
Developing and delivering cell and gene therapies necessitates the handling of living, breathing cells in transit – sometimes across great distances. You have to know exactly where your cells are at all times, who they belong to, and who has handled them. Often, you’ll have to coordinate the activities of multiple clinical centers too: condition the patient, book the bed, align your clinicians, and get the delivery in all at the right time. One mishap could mean a seriously ill patient missing their treatment, and the loss of hundreds of thousands of dollars’ worth of product.
Welcome to the world of cell and gene therapy logistics! Here, four esteemed experts in the field explore the challenges in more detail.
Matthew Lakelin - Chief Scientific Officer, TrakCel
Phil Vanek - General Manager, Cell and Gene Therapy Strategy, GE Healthcare
Heidi Hagen - Chief Strategy Officer and Co-Founder, Vineti
Simon Ellison - Cell & Gene Therapy Service Director, World Courier
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