Supply of drug substance manufactured under cGMP supports first-in-human clinical study for RBI-4000 novel self-replicating RNA (srRNA)
ALBANY, N.Y., Sept. 13, 2023 (GLOBE NEWSWIRE) — Curia, a leading contract research, development and manufacturing organization, today announced that its partner, Replicate Bioscience, has received IND clearance from the FDA and has dosed the first participant with RBI-4000, a self-replicating (srRNA) rabies vaccine, in a Phase 1 clinical study utilizing clinical material developed as part of the collaboration with Curia.
Curia conducted process development, scale-up and cGMP manufacture of srRNA RBI-4000 drug substance. At approximately 10,000 bases, this srRNA is significantly larger than a conventional linear mRNA and has been historically difficult to manufacture at the scales required for clinical development. Curia’s analytical method development and qualification of the assays were also critical to the release of this srRNA molecule.
“Curia is proud to be a pioneer in manufacturing this new class of srRNA technology by delivering RBI-4000 srRNA drug substance to our partner Replicate in support of their Phase 1 clinical trial,” said Christopher Conway, President, Research & Development, Curia. “We are dedicated to providing advantaged solutions from development to cGMP manufacture for our customers in the mRNA field.”
This new class of srRNA vaccine offers a number of potential improvements to existing mRNA vaccines, including lower dosage requirements and improved tolerability. The advancement also opens the door for further RNA innovation for use in vaccines and therapeutics with fewer constraints on molecule size.
“Our collaboration with Curia helped us manufacture a new class of self-replicating RNAs which have the potential to deliver improved bioactivity, tolerability and efficacy profiles as compared to other RNA technologies,” said Nathaniel Wang, Ph.D., founder and CEO of Replicate. “Curia scaled up a process for longer RNAs that enabled large-scale production at yields, purity and potency to support Replicate’s Phase 1 clinical trial.”
Curia is committed to being a partner of choice from discovery and development through manufacture and commercialization, providing a full suite of services to support small and large molecule, drug substance, drug product aseptic fill-finish and laboratory testing at every phase of the drug development life cycle.
Curia, formerly AMRI, is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com.
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