Page 400 - Binder2
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•  Seeds embedded with the genetic instructions for
                       Factor IX were planted in modular greenhouses.
                   •  Leaves were harvested, freeze-dried, and milled into
                       capsules.
                   •  Capsules were compounded into patient-specific
                       dosing regimens and distributed directly through the
                       local health center.


               The outcome?

                   •  Therapy costs dropped by over 90%.
                   •  No cold chain was required.
                   •  Supply was no longer fragile.
                   •  Patients gained consistency, confidence, and
                       control.


               This wasn’t just a medical intervention—it was an
               economic and cultural one, reshaping what a rural clinic
               could offer its community.




               Challenges and Realities


               Of course, scaling this model won’t be easy. It requires:

                   •  Regulatory adaptation. Current FDA and EMA
                       standards are designed around centralized GMP
                       facilities. Decentralized plant production will
                       demand new safety, traceability, and validation
                       frameworks.
                   •  Rethinking intellectual property. Can therapeutic
                       plants be shared, or will multinational firms license
                       every leaf? Will communities be allowed to grow
                       what they co-develop?



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