27 December 2021 | Monday | News
Image Source : Public Domain
Curia, formerly AMRI, a leading contract research, development and manufacturing organization, today unveiled its messenger RNA (mRNA) solution, which includes discovery, process development and mRNA drug substance production, through large-scale lipid manufacturing, lipid nanoparticle (LNP) formulation and development for full-scale sterile fill-finish services.
Curia’s mRNA solution is designed to streamline the development and delivery of mRNA-based products, which span various therapeutic areas including cancer, heart disease and chronic illnesses 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 Chairman and Chief Executive Officer John Ratliff. “mRNA has the potential to play a pivotal role in the next frontier of treatments for unmet medical needs. Curia’s capabilities enable customers to accelerate the discovery and development of next-generation mRNA therapeutics from curiosity to cure.”
Curia’s team brings a powerful combination of proven expertise, speed and reliability across research, process development and manufacturing to accelerate mRNA product development timelines:
Curia’s mRNA solution combines expertise and a proven track record of success in key scientific disciplines including molecular biology, protein production and analysis, enzymes, nucleosides and lipids. The platform’s ability to provide high-quality constructs through in-house research and analysis capabilities enables accelerated timelines for delivery.
Development of Lipid and RNA Drug Substance Through Manufacturing
Curia’s end-to-end capabilities extend from production of plasmid DNA and manufacturing of enzymes and nucleosides at gram-to-kilogram scale, to drug substance development through first-in-human clinical supply manufacturing. Its five sites in California and Massachusetts provide reliable plasmid production for “traditional” and self-amplifying mRNA drug substance. First-in-human clinical-scale cGMP manufacturing is supplemented by in-house analytical capabilities for product testing and release.
Curia has a proven track record in the rapid development of numerous specialized lipids for mRNA applications and the ability to manufacture lipids to metric-ton scale in accordance with cGMP. Curia’s scientists have expertise in coupling synthesis with highly effective separations and purifications of APIs and functional excipients.
Development of Lipid Nanoparticle Formulation, Testing and Sterile Fill-Finish Through Manufacturing
Curia’s mRNA solution includes complex formulation capabilities and experience in liposome and lipid nanoparticles led by its expert scientists. Curia completes its end-to-end offering with clinical and commercial aseptic sterile fill-finish capability and capacity. Its facilities provide process development and first-in-human clinical manufacturing through to full commercial manufacturing of mRNA injectable dosage products in accordance with cGMP.