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should endpoints be measured? Are immune
biomarkers sufficient? What does a Phase 2 success
look like?

The solution lies not in forcing edible biologics into old
categories—but in co-developing new ones with forward-
looking regulatory partners.

Early engagement. Open data. Shared frameworks.
That’s how first movers will define the rules instead of
getting caught in them.

Manufacturing and Scale-Up Hurdles

Growing medicine in plants isn’t inherently hard.
But growing consistent, pharmaceutical-grade medicine
at scale is a different story.

Key challenges include:

• Environmental variability – Even controlled
greenhouses are sensitive to water, light, and
temperature fluctuations.
• Harvest and processing logistics – Scaling from a
lab bench to a multi-acre operation requires precise
timing and reproducible workflows.
• Facility standards – Unlike traditional pharma
plants, most countries don’t have regulatory
precedents for how to inspect and certify plant-
based therapeutic farms.

Startups and developers will need to blend agricultural
engineering with GMP rigor—a novel fusion of
industries that have historically never met.

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