Page 337 - Binder2
P. 337
incidents, manufacturing shortfalls, regulatory setbacks, or
equipment failures in centralized plants.
Every biologic product must be made in a qualified facility.
Every facility must be inspected, certified, and compliant
with current Good Manufacturing Practices (cGMP).
And every delay or deviation—no matter how minor—can
trigger a cascade of regulatory, financial, and clinical
consequences.
The result?
Bottlenecks. Fragility. Single points of failure.
To mitigate that risk, companies invest billions in
redundant facilities, contract manufacturing organizations
(CMOs), and global contingency plans. But even then,
disruption is a constant threat—from viral contamination in
CHO cell lines to sterile filtration failures or cold chain
breakdowns.
Edible Biologics Break the Bottleneck
Plant-based biologics change that equation completely.
Rather than centralizing production into a few massive
facilities, edible platforms enable distributed, parallel
manufacturing—using greenhouses, vertical farms, or
modular growth units that can be replicated across sites,
geographies, and organizations.
If a bioreactor facility goes down, the product stops.
If a greenhouse goes offline, the crop is just replanted
elsewhere.
335
