Page 282 - Binder2
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glycosylation isn’t a downstream QC issue. It’s an
               upstream design decision.


               That means:

                   •  Engineering expression systems (mammalian, yeast,
                       plant, or otherwise) to produce human-like glycan
                       profiles.
                   •  Eliminating immunogenic sugar structures at the
                       genomic level.
                   •  Using cell-free systems or controlled bioreactor
                       environments that reduce variability.
                   •  And, in some cases, removing glycosylation sites
                       altogether when they don’t contribute to function
                       but pose immunologic risk.


               Some plant-based platforms, for example, have already
               inserted human glycosylation enzymes into lettuce and
               duckweed, effectively “humanizing” their output. Others
               have stripped out plant-specific sugars to create cleaner,
               more tolerable proteins.

               This isn’t about cosmetic tweaks.
               It’s about trust—between a drug and the body that must
               accept it.


               Why It’s Been Overlooked


               Glycosylation isn’t glamorous. It’s not the kind of
               breakthrough that makes headlines. It lives in the shadows
               of the biologic development process—talked about in
               manufacturing meetings and regulatory filings, but rarely in
               the marketing brochure.


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