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2.6 – Scientific Gaps and

Engineering Shortcuts

The biologics we celebrate today—Remicade, Humira,
Keytruda, and their many successors—are marvels of
molecular engineering. They were designed to bind with
exquisite precision, to neutralize specific immune signals,
to do what small molecules never could. And in many
ways, they delivered.

But beneath the sophistication lies a crucial omission:
biologics were engineered to be effective, not to be
accepted.
They were built for performance, not for harmony.

And that omission—of immune compatibility as a design
constraint—has come at a steep cost.

Let’s start with the science.

Biologics are large, complex drugs made from living
cells—not chemicals mixed in a lab. They’re often proteins
like antibodies or fusion molecules that need to be folded
and modified just right to work. But because they’re grown
in living systems, no two batches are exactly the same.
Even small changes in how they’re folded or decorated
with sugars can look foreign to the immune system. And
once the body decides the drug is a threat, it can start to
attack it—making the treatment less effective, or even
useless.

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