TriLink BioTechnologies Announces New San Diego Facility for Late Phase mRNA Drug Substance Production

TriLink BioTechnologies (TriLink), a Maravai LifeSciences company 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.

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.