ALBANY, N.Y., Sept 14 (Bernama-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.