TriLink BioTechnologies today announced it opened its new cGMP mRNA manufacturing facility.
The new 32,000 sq. ft. facility, based in San Diego, is specifically designed for mRNA manufacturing. Using the company’s mRNA manufacturing capabilities, it will support late-phase drug developers from Phase 2 to commercialization. TriLink said the opening is expected to help advance the field of mRNA-based medicine.
TriLink’s new facility has individual Grade C cleanroom suites for mRNA manufacturing, increased mRNA capacity, comprehensive in-house analytical services and laboratory space for on-site quality control testing. The manufacturing site is also outfitted with “state-of-the-art” equipment and is 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,” Kevin Lynch, VP and GM of TriLink’s GMP operations, said in a news release. “The high-quality manufacture of mRNA drug substances is critical to ensuring the safety and efficacy of this new class of medicines for patients.”
The company has been providing GMP services to drug developers since debuting its first cGMP facility in 2015. Since then, its team of scientists has provided over 1,000 clients with custom mRNA synthesis, supported more than 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,” said 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.”
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