GMP Facility Expected to Simplify the mRNA Drug Substance Development Process; Slated to Welcome Customers in Early 2024
SAN DIEGO –TriLink BioTechnologies (TriLink®), a Maravai LifeSciences company (NASDAQ: MRVI) and global provider of life science reagents and services, has announced the expansion of 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.
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.”
Just minutes from the company’s San Diego headquarters, the new facility boasts 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,” added 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.”
To learn more about TriLink’s products and services, visit trilinkbiotech.com
About TriLink BioTechnologies
TriLink BioTechnologies, a Maravai LifeSciences company, is helping to realize the power and potential of mRNA. As a global leader in nucleic acid and mRNA solutions for more than 25 years, TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its proprietary CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans.
For more information about TriLink, visit www.trilinkbiotech.com.
Maravai is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines. Maravai’s companies are leaders in providing products and services in the fields of nucleic acid synthesis and biologics safety testing to many of the world’s leading biopharmaceutical, vaccine, diagnostics, and cell and gene therapy companies.
For more information about Maravai LifeSciences, visit www.maravai.com.
This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release which are not strictly historical statements constitute forward-looking statements, including, without limitation, statements related to the expectation that our expanded manufacturing capabilities will simplify and contribute to mRNA therapeutics development, our ability to attract and serve late-phase drug developers, an increase of mRNA-based therapeutics and vaccines entering later-stage clinical trials, and our ability to help to take critical therapeutics from concept through late-phase clinical mRNA drug substance manufacturing constitute forward-looking statements identified by words like “expect,” “estimate,” “may,” “soon,” “nears,” “slated,” “anticipate,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation and uncertainties related to construction and permitting delays, availability and delays in delivery of equipment, continued validation of the safety and effectiveness of our technology, and new scientific developments and competition from other products. These and other risks and uncertainties are described in greater detail in the “Risk Factors” section of our most recent Annual Report on Form 10-K, as well as other reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from those contemplated by these forward-looking statements, and therefore you should not rely upon them. These forward-looking statements reflect our current views and we do not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.