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• Children at genetic risk for autoimmune diseases
receive oral tolerance boosters
• Allergies are prevented before they ever manifest
• Immune resilience is built—not by shielding the
body, but by training the system to see correctly

This is not speculative.
This is the next chapter of immunology—written not in
syringes, but in seeds.

4.8 Regulatory and Commercial Pathways for
Edible Biologics

Innovation doesn’t just require science.
It requires permission.

No matter how novel or effective a therapy may be, it
cannot reach patients without regulatory approval. And
when it comes to edible biologics—therapeutic proteins
grown in plants and delivered orally—we are entering
largely uncharted territory.

These therapies blur familiar boundaries:

• Drug or food?
• Plant or product?
• Vaccine or immune conditioner?
• Biologic or device?

For regulators and commercial partners alike, edible
biologics demand new frameworks, new questions, and
new kinds of confidence.

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