Page 282 - Binder2
P. 282
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.
280