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And without it, companies are forced to either retrofit their
products into old regulatory molds—or wait, indefinitely,
for new rules to emerge.

Safety vs. Familiarity

Here’s the irony: plant-made biologics may be inherently
safer than their mammalian-cell counterparts. They lack
endotoxins. They don’t harbor mammalian viruses. They’re
often grown in edible plant species already approved for
human consumption. But that very familiarity works
against them.

Because they look like food, they are not taken seriously as
medicine.

Because they come from lettuce instead of a stainless-steel
reactor, they are assumed to be imprecise.

And because they don’t conform to the sterility
requirements of injectable drugs, they are often
dismissed—even though oral delivery has different, and
arguably more forgiving, standards for microbial
burden.

This mismatch between perception and reality—between
what regulators are used to and what the science now
allows—creates a vacuum of guidance. And in that
vacuum, innovation stalls.

The Risk-Averse Reflex

Ultimately, regulators are not incentivized to be first. They
are incentivized to avoid error.

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