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These systems aren’t excess—they’re core to how these
companies function and justify their scale. Regulatory
filings, CMC (Chemistry, Manufacturing, and Controls)
documentation, and global logistics are calibrated to these
industrial-grade infrastructures.

Everything is interlocked: the facility, the filing, the
regulatory plan, the global supply chain, the internal
headcount. These systems are slow, expensive, and
robust—but they are also resilient to change. Because to
change them is to risk the collapse of the very foundations
that support the company’s operations.

Edible Biologics Flip That Script

Now imagine a therapeutic that requires none of this.

● The drug isn’t made in CHO cells—it’s expressed in
lettuce.
● The protein isn’t purified—it’s stabilized inside the
plant matrix.
● The final product isn’t a sterile injectable vial—it’s
a capsule of freeze-dried, milled leaf powder.
● The production site isn’t a cleanroom—it’s a
climate-controlled greenhouse.

For legacy systems, this is more than disruptive—it’s
disorienting. The familiar checkpoints disappear. The
expected infrastructure becomes irrelevant. Entire
departments—sterile fill-finish, cold-chain logistics, and
even parts of biologics CMC teams—become
diminished or obsolete.

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