Page 283 - Binder2
P. 283

And yet, it may be one of the single biggest reasons why
               biologics fail immunologically.


               Because even when the protein is perfect, the sugars can
               sabotage it.

               And until we design with that in mind—until we treat
               glycosylation as an immune signal, not a structural
               afterthought—we will keep producing therapies that lose to
               tolerization before they ever had a chance to last.


               The immune system reads more than the label. It reads the
               whole molecule.
               And if the sugars don’t add up, the therapy never stood a
               chance.


               Step 6: The AI Solution


               Obviously, we have huge problems here.

               Biologics are sensitive.


               Not just to formulation or storage—but to the environment
               in which they’re made. Temperature. Light. Humidity. Soil
               nutrients. Oxygen gradients. Even subtle differences in
               airflow or bioreactor geometry can shift a cell’s behavior.
               In a traditional stainless-steel facility, these variables are
               aggressively controlled—but not eliminated. And in plant-
               based systems, they are even more nuanced: leaves don’t
               grow in vacuum-sealed sterility. They grow in light and
               water and weather.


               That variability has long been the Achilles’ heel of
               alternative biologic production.

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