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A New Kind of Asset Meets an Old System

The current regulatory frameworks—such as the FDA’s
CDER (Center for Drug Evaluation and Research) and
CBER (Center for Biologics Evaluation and Research)—
were built around purified, injectable biologics, often
produced in standardized cell lines like CHO or E. coli.
These systems assume:

• Sterile production in GMP facilities
• Protein purification before formulation
• Defined pharmacokinetics based on bloodstream
exposure
• IV or subcutaneous administration

Edible biologics, by contrast, introduce a fundamentally
different profile:

• The active drug is produced within an edible
organism
• The therapeutic is often not purified, but stabilized
within the plant matrix
• The site of action is mucosal, not systemic
• The delivery method is oral, with variable
absorption and local immune training
• Stability is ambient, not cold-chain dependent
• And the platform may resemble food more than a
traditional pharmaceutical

This raises complex regulatory questions:

• Is the plant material the drug, or the delivery
system?
• Does the entire capsule require GMP classification?
• How is dosing defined when the protein is
embedded in biomass?

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