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GMP facility expected to simplify the mRNA drug substance development process.
May 24, 2023
By: Anthony Vecchione
TriLink BioTechnologies, a Maravai LifeSciences company and global provider of life science reagents and services, is expanding its mRNA manufacturing capabilities to serve late-phase drug developers. TriLink’s construction of the new 32,000-square-foot, cGMP-grade facility solidifies its commitment to advancing the field as more mRNA-based therapeutics and vaccines enter later-stage clinical trials. The new facility is scheduled to open in early 2024. TriLink has reliably delivered GMP services to its customers since the debut of its first cGMP manufacturing facility in 2015. Built to meet the need of a rapidly growing market, the new cGMP facility is expected to contribute to the development of vital mRNA therapeutics. The building has been designed for the cGMP manufacture of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines. “The expansion of our cGMP mRNA manufacturing capabilities marks a major milestone for TriLink and our partners,” said Becky Buzzeo, chief commercial officer at Maravai LifeSciences. “Drug developers will soon be able to leverage our team’s 25-plus years of industry expertise, helping to take critical therapeutics from concept to plasmid DNA through to late-phase clinical mRNA drug substance manufacturing with ease.” The new facility features ISO 7 cleanrooms and increased mRNA capacity (1g to >50g per batch), with comprehensive in-house analytical services also available. “Our team took great care in building and designing our new facility– it’s truly been a labor of love,” said Rob Carpenter, vice president of engineering at TriLink. “In addition to having access to a state-of-the-art facility, developers will also have a direct line to our experienced team to help with process optimization, scale-up, validation, and qualification capabilities.”
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