Page 274 - Binder2

When you look at previous failed attempts to develop
plant-based biologics the narrative is inconsistency. The
smallest environmental differences can cause large scale
changes in the protein structure experessed. Even when you
grow a plant in a greenhouse recombinant protein
expression variance is between 10-30% across batches.

Would you take a drug where each pill is 10-30% different
from the last?

Luckily the FDA won’t let you. Variance is highly
regulated because of the impact it can have on the
effectiveness of the drug. The most common types of
protein variance due to the growth are yield and
glycosylation. Essentially how much of a drug that a plant
makes and how the plant coats the protein in sugars.

Yield

In the world of biologics, yield is gospel.

Ask any manufacturing lead, platform developer, or
investor due diligence team what matters most after purity,
and the answer will almost always be the same: “How
much protein do you get per liter?”

It’s a reasonable question—until you realize how deeply it
distorts the real goal.

Because high yield doesn’t mean high value.
And when it comes to immune-compatible biologics,
chasing raw output can be exactly the wrong strategy.

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