Vaxcyte secures US$1B fill-finish capacity with Thermo Fisher

USA— North Carolina’s biopharma sector is experiencing a surge in onshoring investments, with clinical-stage vaccine developer Vaxcyte among the latest companies establishing manufacturing operations in the state.

Following the trend of other pharmaceutical firms expanding production in North Carolina, Vaxcyte plans to leverage the region’s extensive CDMO (contract development and manufacturing organization) capabilities.

The company has committed up to US$1 billion to Thermo Fisher Scientific for access to vaccine fill-finish capacity at the CDMO’s Greenville, North Carolina facility.

This agreement covers Vaxcyte’s pipeline of broad-spectrum pneumococcal conjugate vaccines (PCVs) and is described as a “long-term U.S. commercial manufacturing commitment.”

While Vaxcyte has not yet received FDA approval for any product, the collaboration with Thermo Fisher is part of its broader long-term commercial supply strategy.

Vaxcyte’s lead vaccine candidate, VAX-31, a 31-valent PCV, is currently progressing through a phase 3 trial in adults and a phase 2 study in infants.

Other candidates in the pipeline include VAX-24, a 24-valent PCV; VAX-A1, a prophylactic vaccine targeting group A strep infections; and VAX-GI, designed to prevent shigella infections.

Grant Pickering, Vaxcyte’s CEO and co-founder, said the decision to expand fill-finish manufacturing capacity in the U.S. reflects a strategy to enhance end-to-end supply and align with the growing emphasis on domestic biomanufacturing.

Vaxcyte’s investment complements a wave of similar moves by biopharma companies in North Carolina, a state known for its strong presence of contract manufacturing and development organizations.

Recently, Fujifilm Biotechnologies inaugurated a US$3.2 billion biologics manufacturing plant in Holly Springs, approximately 100 miles west of Greenville.

The CDMO facility started operations with eight 20,000-liter bioreactors for drug substance and product manufacturing, with plans to double capacity by 2028.

Fujifilm has already secured significant long-term contracts with major companies including Regeneron Pharmaceuticals, Johnson & Johnson, and argenx.

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