Curia’s mRNA services combine a comprehensive experience and flexible capabilities, from discovery to filling manufacturing.
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, has unveiled its messenger RNA (mRNA) solution, which includes the discovery, process development and production of mRNA drug substances, through the manufacture of large-scale lipids, lipid nanoparticles (LNP) formulation and development of large-scale sterile fill-finish services.
Curia’s mRNA solution is designed to streamline the development and delivery of mRNA products, which cover various therapeutic areas including cancer, heart disease and chronic disease, in addition to its current application in vaccines.
“The extraordinary impact of mRNA on the COVID-19 pandemic demonstrates its potential to save and improve lives,” said Curia CEO John Ratliff. “MRNA has the potential to play a central role in the next frontier of treatments for unmet medical needs. Curia’s capabilities enable clients to accelerate the discovery and development of next-generation mRNA-based therapies, from curiosity to cure.
The Curia team brings a powerful combination of proven expertise, speed and reliability in research, process development and manufacturing to accelerate mRNA product development times:
Curia’s mRNA solution combines expertise and proven track record of success in key scientific disciplines including molecular biology, production and analysis of proteins, enzymes, nucleosides and lipids. The platform’s ability to deliver high-quality builds through in-house research and analysis capabilities enables accelerated delivery times.
Development of lipid and RNA drug substance by manufacturing
Curia’s end-to-end capabilities range from the production of plasmid DNA and the manufacture of enzymes and nucleosides at the gram-to-kilogram scale, to the development of drug substances and the manufacture of clinical supplies. for the first time in humans. Its five sites in California and Massachusetts provide reliable production of plasmids for “traditional” and self-amplifying mRNA drugs. The first human clinical scale cGMP manufacturing is complemented by in-house analytical capabilities for product testing and release.
Curia has a proven track record in the rapid development of many specialized lipids for mRNA applications and the ability to manufacture lipids at the metric ton scale in accordance with cGMP. Scientists at Curia have expertise in coupling synthesis with highly efficient separations and purifications of APIs and functional excipients.
Development of the formulation of lipid nanoparticles, from testing and sterile filling to manufacturing
Curia’s mRNA solution includes complex formulation capabilities and experience in liposomes and lipid nanoparticles led by its expert scientists. Curia complements its end-to-end offering with clinical and commercial aseptic sterile filling and finishing capacity and capability. Its facilities provide process development and first human clinical manufacture to full commercial manufacture of injectable mRNA assay products in accordance with cGMP.
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