Special Issue: CPHI Frankfurt 2025 Preview

On Demand: Interview with Timothy Compton, Chief Strategy Officer, Alcami

U.S. Bio/Pharma Manufacturing Demand on the Rise

In advance of CPHI Frankfurt 2025, Alcami’s Chief Strategy Officer Timothy Compton sat down with Future Biopharma to discuss the latest factors influencing bio/pharma manufacturing strategy.

As Compton notes, the surge in demand for U.S.-based manufacturing is being shaped by evolving geopolitical conditions, supply-chain security, and the Biosecure Act. “Clearly, the largest driver [to this U.S. manufacturing demand] is the geopolitical [situation], with the Biosecure Act coming back into play, potentially, and obviously the trade policies that are unknown, but causing a bit of a stir in the space,” he explains.

Beyond policy, the long-standing conversation around reshoring and onshoring continues to gain traction. “There are a lot of reasons and rationale to reshore and onshore,” Compton says. “One being quality: certainly, quality culture in the U.S. is bar to none across the rest of the world.”

Adapting Manufacturing Strategies to Biologics Growth

The rise of biologics has transformed how manufacturing partners approach production. “Here at Alcami, we’ve seen batch sizes reduce in size,” says Compton. “We more often hear ‘how small the batch can use sterile fill-filter,’ as opposed to ‘how large a batch you can sterile filter,’ whereas 10 or 12 years ago it was always about going bigger.”

To meet evolving client needs, Alcami offers flexible batch capacity—from up to 1,000 L down to 1 L or smaller—and continues to invest in analytical capabilities. “Another factor impacting manufacturing strategies is the ability to release and characterize the molecules, either drug substance or drug product,” Compton adds. “We’ve got a lot of expertise in-house to support that, and right now, we’re expanding our capacity for biologics analytical testing in our Raleigh-Durham location.”

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