Reshoring biologics: geopolitics meets GMP

The biologics supply chain has shifted from a technical backwater into a political and regulatory battleground. Vectors, plasmids, and the raw materials that feed them are now viewed as strategic assets. The combination of geopolitical pressure, pandemic scars, and new GMP scrutiny has sparked a wave of capacity building, supplier diversification, and make-versus-buy soul-searching across the USA and Europe.

The momentum is hardly abstract. In Washington, the BIOSECURE Act has advanced again, with committee approval this September signaling fresh appetite to curb the use of Chinese CDMOs in federally linked projects.

Meanwhile, in Brussels, HERA and the Commission’s pharmaceutical strategy are pulling manufacturing back onto European soil under the flag of “open strategic autonomy.” This is reshoring as risk management — and compliance as much as cost.