KUALA LUMPUR, Sept 18 (Bernama) -- Curia, a contract research, development and manufacturing organisation, announced its partner Replicate Bioscience, has received investigational new drug (IND) clearance from the United States Food and Drug Administration (FDA).
In addition, it has dosed the first participant with RBI-4000, a self-replicating (srRNA) rabies vaccine, in a phase one clinical study utilising clinical material developed as part of the collaboration with Curia.
According to a statement, Curia conducted process development, scale-up and Current Good Manufacturing Practice (cGMP) manufacture of srRNA RBI-4000 drug substance.
“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 one clinical trial.
“We are dedicated to providing advantaged solutions from development to cGMP manufacture for our customers in the mRNA field,” said Curia President, Research & Development, Christopher Conway.
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 committed to being a partner of choice from discovery and development through manufacture and commercialisation, 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.
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