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• Create validated protocols for local grow units,
whether in greenhouses, shipping containers, or
vertical farms
• Build QA/QC toolkits that can be deployed in rural
or resource-limited settings
• Train a new kind of workforce: part agronomist,
part GMP technician
• Digitize process control so that every batch in
every region can be tracked, traced, and trusted
This is not just about growing drugs.
It’s about building a biologic supply chain that’s
regional, resilient, and reliable.
4. Invest in Rigorous Clinical Validation
Tolerogenic therapies. Oral antibodies. Enzyme treatments.
These are not marginal ideas—they’re breakthrough
categories in immunology and chronic disease.
But they will never be adopted at scale without:
• Blinded, controlled trials showing safety and
efficacy
• Durability metrics that track immune response
over time
• Head-to-head comparisons against existing
biologics
• And clear PK/PD modeling, even when systemic
absorption isn’t the mechanism
We must design studies that reflect the unique value
proposition of edible biologics:
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