cGMP Facility Streamlines Clinical & Commercial mRNA Drug Substance Development;
Built by mRNA & Industry Experts to Meet Demand for mRNA-based Medicine
TriLink BioTechnologies (TriLink®), a Maravai LifeSciences company (NASDAQ: MRVI) and global provider of life science reagents and services, has announced the grand opening of its new cGMP mRNA manufacturing facility. The 32,000-square-foot facility was specifically designed for mRNA manufacturing to support late-phase drug developers from Phase 2 to commercialization via TriLink’s robust mRNA manufacturing capabilities. The milestone opening is expected to help advance the field of mRNA-based medicine as developers flock to leverage the promising modality for a growing list of indications.
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TriLink BioTechnologies® Cuts Ribbon on New San Diego Facility for Late Phase mRNA Drug Substance Production (Photo: TriLink BioTechnologies®)
Located in the Sorrento Valley area of San Diego, the facility features individual Grade C cleanroom suites for mRNA manufacturing, increased mRNA capacity (1g to >100g per batch), comprehensive in-house analytical services, and laboratory space for on-site quality control testing. The manufacturing suites are outfitted with state-of-the-art equipment and ready to onboard clients with late-phase manufacturing needs.
“This facility is expected to help move the needle for life-saving breakthroughs in mRNA-therapeutics,” explained Kevin Lynch, Vice President & General Manager of TriLink’s GMP Operations. “The high-quality manufacture of mRNA drug substances is critical to ensuring the safety and efficacy of this new class of medicines for patients.”
Company and site leadership and industry guests gathered on April 17 to celebrate the facility’s grand opening with a ribbon cutting, expert-led panel discussion, and site tours – all centered around a core theme: Building the Future of mRNA. The thought-provoking panel included insights on the mRNA regulatory landscape, manufacturing evolution, and next-generation tools.
TriLink has reliably delivered GMP services to drug developers since the debut of its first cGMP facility in 2015. Since then, the company’s dedicated team of scientists has provided over 1,000 clients with custom mRNA synthesis, supported 350+ programs in biopharma development pipelines, and delivered over 100 GMP mRNA manufacturing batches.
“TriLink’s depth of industry experience – which spans over 25 years – coupled with its capabilities makes for an unmatched partner,” shared Drew Burch, President of Nucleic Acid Production. “This new facility codifies our commitment to advancing the field by playing a key role in the development of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.”
In addition to CDMO services and unique mRNA, oligonucleotide, NTP, and plasmid production capabilities, TriLink has developed the award-winning CleanCap® mRNA capping technology used in the majority of approved COVID-19 mRNA and saRNA vaccines, adding momentum to the rapidly growing field.
To learn more about TriLink’s products and services, visit trilinkbiotech.com.
About TriLink BioTechnologies
TriLink BioTechnologies, a Maravai LifeSciences company, is a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its patented 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, visit trilinkbiotech.com.
About Maravai LifeSciences
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.
Forward-looking Statements
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 the facility will help advance the field of mRNA-based medicine and will help move the needle for life-saving breakthroughs, 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, operational risks and competition. 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.
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