Arcturus picks Thermo Fisher to support mRNA manufacturing

The collaboration with the CDMO covers Phase 3 clinical supply and commercial manufacturing for Arcturus Therapeutics’ investigational cystic fibrosis therapy.

Arcturus Therapeutics, a San Diego-based developer of messenger RNA (mRNA) medicines, has entered into a strategic collaboration with Thermo Fisher Scientific to support Phase 3 development and potential commercialization of its investigational cystic fibrosis therapy, ARCT-032.

Thermo Fisher, a Waltham, Massachusetts-based life sciences services and contract development and manufacturing organization (CDMO), will provide Phase 3 manufacturing, clinical research, and commercial readiness services. If ARCT-032 advances following Phase 2 studies and receives regulatory approval, Thermo Fisher will hold exclusive commercial manufacturing rights under a separate agreement, according to the announcement.

The collaboration will use Thermo Fisher’s integrated development model, combining manufacturing, clinical research and commercialization capabilities to support the therapy through late-stage development and potential commercial supply.

Arcturus said the agreement is intended to streamline development activities as the company prepares its mRNA therapy for Phase 3 clinical trials and potential commercialization.

The announcement builds on Thermo Fisher’s continued expansion of its CDMO capabilities. Last week, the company announced an agreement with AustinPx to install KinetiSol bioavailability enhancement technology at its Bend, Oregon, and Cincinnati, Ohio, manufacturing sites. The addition reportedly expands Thermo Fisher’s advanced formulation capabilities for late-stage development and commercial manufacturing of oral drug products.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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