Page 175 - Binder2

For decades, the gold standard for biologic manufacturing
has centered on microbial and mammalian cell systems—
CHO (Chinese hamster ovary) cells, E. coli, and yeast.
These platforms have delivered some of the most
successful therapies in history. But they were built for a
different era: an era of centralized manufacturing, high-
margin pricing, and tolerable waste.

Today, those assumptions no longer hold.

As the industry shifts toward durability, decentralization,
and global access, the limitations of conventional systems
are becoming harder to ignore:

• High production costs – Mammalian cell culture is
expensive, requiring costly growth media, intensive
monitoring, and time-consuming scale-up.
• Contamination risks – CHO and microbial
platforms are susceptible to endotoxins,
adventitious viruses, and cross-batch
contamination—each with significant regulatory
consequences.
• Complex purification pipelines – Downstream
processing is often the most expensive part of
production, especially for biologics requiring sterile
fill-finish and high purity.
• Cold-chain dependency – Many biologics must be
refrigerated throughout the supply chain, increasing
logistical complexity and limiting geographic reach.
• Infrastructure dependency – These platforms
require industrial-scale bioreactors and sterile
facilities—assets concentrated in high-income
regions.

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