The Perils in Managing mRNA Supply Chains. Get it Wrong, People Die—Part 1
This is my patch
When I say ‘this is my patch’, it means I have a 40-year career in building, managing and improving biologics supply chains. That includes the mRNA (and viral vector based) gene-modified cell therapies. I hope, therefore, that subscribers will be inclined to believe what I am about to cover.
I was there
I worked on the drug substance supply chain for the first gene-modified cell therapy that was approved by the US Food and Drug Administration (FDA) on Aug. 30, 2017—Kymriah. More can be found on that below:
The technology involves a lentiviral vector delivering the gene-modified cells into a patient’s body. The theory is that when a virus enters the host (body), it replicates its own DNA and that’s what makes you sick. If you replace the virus’ DNA with gene-modified cells, the virus replicates the ‘good’ cells instead of its own DNA, and it could potentially be a cure. There is a lot to be said about that theory, but for now, I will focus on the supply chain perils associ…