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No stainless steel.
No centrifuges.
No chromatography columns.
No sterile fill-finish suites.
The entire process can be carried out in GMP-compliant
agricultural facilities that look more like a high-tech
vertical farm than a pharmaceutical fortress. And for a wide
class of therapeutic applications—especially oral delivery
for enzyme replacement, mucosal immunotherapy,
tolerogenic vaccines, and GI-targeted biologics—the
protein never needs to be purified at all. The plant tissue
is the formulation.
From 100 Patients to 10,000
What does this mean for scale-up?
In traditional biologics, scaling from 100 to 10,000 patients
may require:
● A doubling of bioreactor capacity
● Redesigning downstream purification
● Redundant quality systems and increased batch size
risk
● Regulatory requalification of facilities and
processes
In a plant-based system?
You add more trays.
More rows of lettuce.
More freeze-dryers.
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