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Figure 6. Reasons why two batches of biologics differ
structurally
Unlike small molecules, which are inert to the immune
system, biologics are visible. They are scanned, processed,
and sometimes targeted by adaptive immunity. Yet most
are delivered in ways the immune system wasn’t designed
to tolerate: intravenously, bypassing oral and mucosal
immune pathways. What results is a paradox—drugs that
are biologically active, but immunologically alien.
When you have large foreign proteins in the highly
intelligent human immune landscape the body mounts a
response. The bouncers of the bloodstream, antigen
presenting cells (APCs) swarm these foreign molecules.
The immune system then stages a humoral response,
anything that resembles the drug designed to save the
patient is marked as an intruder.
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