Cellipont and Soter Bio partner to manufacture lipid nanoparticles - BioProcess International

Contract development and manufacturing organization (CDMO) Cellipont Bioservices announced a partnership with Soter Bio, a CDMO specializing in the development of lipid nanoparticles for RNA therapies. The companies will collaborate on integrated manufacturing techniques to produce complex cell therapies.

As part of the partnership, Soter Bio will provide GMP-manufacturing for RNA products, and Cellipont will provide cell-therapy manufacturing, regulatory assistance, analytics, early clinical stage support, and late-stage development.

“Soter Bio was built to support advanced therapeutic programs that depend on reliable, rapid, scalable input materials," commented CEO and founder of Soter Bio Mike Stewart in a public statement. “Partnering with Cellipont brings complementary GMP expertise to help sponsors navigate complex development programs while maintaining regulatory rigor and supply continuity."

In its public release, Cellipont said its deal with Soter Bio is part of a strategic plan to consolidate US manufacturing and supply of RNA therapies. This follows the Trump administration’s increasing efforts to incentivize companies to establish US-based manufacturing facilities and supply lines.

“As cell therapies and RNA-enabled approaches become more technically integrated, early alignment across manufacturing stages is critical to de-risk development,” said Darren Head, CEO of Cellipont, in the company’s press release. “Our collaboration with Soter Bio strengthens the domestic manufacturing pathway and provides sponsors with a coordinated model from RNA and biomolecule supply through GMP cell therapy production.”

The partnership will support investigational cell therapies and platforms across biotech, pharmaceutical, and government-affiliated programs. The firms will collaborate with shared clients but will continue to operate independently.

This investment into RNA therapeutics comes amid Health and Human Services (HHS) secretary Robert F Kennedy Jr.’s outward criticism of RNA-based medicines.

Despite the anti-vaccine bluster, the US Food and Drug Administration (FDA) recently published draft guidance that would prioritize individualized RNA drugs and genome-editing therapies for ultra-rare disease.