cGMP mRNA manufacturing facility
TriLink’s facilities meet the demands of mRNA manufacturing at each phase of drug development. Our cGMP mRNA facility has been designed by mRNA and regulatory experts to streamline late-phase clinical and commercial mRNA drug substance manufacturing.
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 an on-site quality control lab. The manufacturing suites are outfitted with state-of-the-art equipment and are ready to onboard clients with late-phase and commercial mRNA drug substance manufacturing needs.
Key facility attributes
- Total footprint: 32,000 ft2 (2,973 m2)
- Three Grade C manufacturing cleanrooms: 1,000 ft2(93 m2) per suite of operational space
- One Grade B fill suite with with Grade A fill line
- cGMP compliance with FDA regulations, in addition to ICH and other applicable guidelines, including 21 CFR Parts 210, 211 & 610
- Buffer preparation and hold area
- Integrated building and environmental monitoring and control systems
- Integrated clean utility processes with backup generator and UPS
Capabilities
- 1 to >100 g batch size; single-use equipment
- Tech transfer of processes from internal and client sites
- Process optimization, development, and scale-up capabilities
- Process qualification, validation, and product characterization
- On-site quality control, monitoring, and release
Grand opening of TriLink's cGMP mRNA manufacturing facility
Determined to deliver to accelerate your path from concept to commercialization
TriLink has reliably delivered GMP services to drug developers since the debut of its first GMP facility in 2015.
Our cGMP mRNA manufacturing capabilities are supported by a passionate team of mRNA and drug substance manufacturing experts, continuously building on our commitment to deliver for our clients.
10,000+ discovery mRNA constructs delivered
1,000+ discovery mRNA clients served
100+ GMP mRNA batches delivered
350+ programs in biopharma development pipelines supported
Partner with mRNA and cGMP manufacturing experts
Learn more about TriLink’s mRNA CDMO Services, or request a consultation with our team using the form below.
Let’s discuss your mRNA program needs!
Connect with our team of GMP mRNA manufacturing experts.
