Page 259 - Binder2

To move forward, developers must engage regulators early
and collaboratively define what good looks like:

• What are the quality metrics for a therapeutic
protein embedded in plant tissue?
• How is consistency measured across crops or grow
cycles?
• How should tolerogenic endpoints or mucosal
responses be validated in trials?

We need new regulatory pathways—tailored, not
retrofitted.
And those pathways must be built in partnership with:

• The FDA
• EMA
• WHO prequalification teams
• National health agencies in regions where these
therapies are most needed

Edible biologics will succeed not because they avoid
regulation—but because they help write the next chapter
of it.

3. Scale Decentralized Manufacturing—with Embedded
QA/QC

One of the greatest advantages of edible biologics is that
they can be produced locally.
But decentralization without standardization becomes
chaos.

To truly unlock modular, distributed manufacturing, we
must:

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