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It’s whether it reaches the patient in Lagos, in La Paz, in
Lahore.
Whether it works where the world actually lives.

4.10 Risks, Roadblocks, and the Path Forward

No breakthrough comes without friction.
And edible biologics—despite their promise—face real
challenges: scientific, regulatory, operational, and cultural.

This is not the smooth path of incremental progress.
It’s a frontier.

And like any frontier, it comes with uncertainty.
But also with outsized opportunity—for those who are
willing to solve what's never been solved before.

Scientific Unknowns

While proof-of-concept studies are encouraging, edible
biologics still face technical risks:

• Proteolytic degradation – Even with plant-based
encapsulation, not all therapeutic proteins will
survive the digestive tract. Developing standardized
strategies for protecting proteins—via
lyophilization, encapsulation, or co-formulation—is
essential.
• Dose variability – Achieving consistent dosing
when proteins are embedded in plant tissue is a
challenge. Standardization of growth conditions,

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