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This creates both a challenge and an opportunity.

What Regulators Will Need to See

To build trust in edible biologics, developers will need to
show:

• Batch consistency – Even when grown in plants,
the drug product must meet pharmaceutical
standards for reproducibility and stability across lots
and growth cycles.
• Functional stability – Proof that the therapeutic
protein remains intact through processing, storage,
and digestion.
• Immunologic mechanism – Clear models
explaining how the drug achieves its effect without
systemic absorption (or, when appropriate, with
targeted uptake).
• Validated manufacturing controls – From
greenhouse GMP protocols to lyophilization and
encapsulation standards.
• Human data – Especially around ADA formation,
Treg induction, or tolerogenic impact—depending
on therapeutic class.

The good news? These are achievable.
What’s needed is clarity, not compromise—and strong
dialogue with regulatory bodies starting at the pre-IND
stage.

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