Part 2 I Infrastructure of Power I Greg Burel former Director of U.S. SNS

Policy has created real momentum around reshoring. However, policy alone doesn’t build facilities.

Everyone is focused on innovation— new therapies, new science, new breakthroughs. But innovation isn’t the constraint.

Infrastructure is.

The real question isn’t what we can discover— it’s whether we can actually produce it.

Right now, the U.S. lacks sufficient validated, GMP-ready manufacturing capacity to support sustained, onshore production.

But even where capacity exists, another issue emerges: Alignment.

Not all capacity is usable. Not all facilities are viable or trusted.

The constraint isn’t just volume— it’s whether infrastructure is aligned with: ☑️the right modalities (e.g., biologics, cell & gene, small molecule)
☑️ the right scale (small batch vs. commercial)
☑️the right technology
Because if capacity isn’t aligned with current therapeutic needs— it doesn’t get used. And unused capacity doesn’t solve reshoring.
This isn’t a policy problem.
This isn’t a science problem.
This is an execution problem.
Reshoring requires:
☑️ Purpose-built, GMP-compliant infrastructure
☑️ Long-term, aligned capital
☑️ Operators who understand how these facilities actually function — not retrofitted for regulatory approval, but built for it from inception.
Not all capital can finance this. Not all developers can build it. And without that alignment, capacity doesn’t materialize.
Reshoring isn’t about building more labs. It’s about building production-scale infrastructure that actually gets used.
Until infrastructure becomes strategic, innovation remains exposed.
Part 2 I Infrastructure of Power
Why Infrastructure is the Constraint #LifeScienceX #Reshoring

#pharmamanufacturing #Infrastructure #GMP
#nationalsecurity

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