AM I STATING THE OBVIOUS?
Most of the world believed it was possible to develop & make a safe, effective, quality-compliant injection in less than 12 months.
If that were ‘obvious’, I wouldn’t need to be reminding people. Hopefully, you are not one of them!
For all the talk about synthetic, computer-generated genetic code and virtual inspections of manufacturing facilities—that is a pipe dream.
In the non-virtual world of physical supply chains, that does not happen.
Why is that, I hear you think?
PHYSICAL PATIENTS NEED PHYSICAL PRODUCTS
Injections are the product of long, complicated, supply chains. What comes out of those supply chains goes directly into your body—your physical body, not a virtual one. Any slip-up along the way could have tragic consequences.
This is why the initial development of any medicinal product, including injections for a gene therapy product, begins