mRNA CDMO services
A clear path to GMP mRNA manufacturing
Bringing your mRNA vaccine or therapeutic through the clinic introduces new demands for process development, scalability, and quality. TriLink® leverages cGMP manufacturing processes to deliver mRNA drug substances at scale.
Partner with TriLink to gain the support you need for your mRNA programs:
- Process development and scale-up with cGMP mRNA manufacturing expertise
- Integration of innovative technologies to streamline mRNA manufacturing
- Robust Quality Management Systems and regulatory submission support
- Manufacturing facility designed by regulatory and mRNA manufacturing experts
- In-house Analytical Services for mRNA analysis and characterization
Process development and scale-up
mRNA manufacturing programs are supported by our robust process development and scale-up capabilities. Streamline the transition from discovery to GMP manufacturing with one partner:
- Discovery-to-GMP pathway includes construct-specific optimization, feasibility, and engineering runs to help ensure successful GMP manufacturing
- Established internal transfer procedures between RUO, process development, and GMP teams
- mRNA programs have dedicated suites for the duration of their GMP manufacturing
- Extensive experience in tech transferring mRNA processes into TriLink’s GMP mRNA manufacturing
Integration of innovative technologies
To seamlessly scale, and optimize mRNA manufacturing, you can integrate TriLink’s GMP-grade raw materials, methods, and innovative technologies into your mRNA program.
- In-house plasmid DNA-to-mRNA pathway
- CleanScript™ in vitro transcription method
- CleanCap® capping solutions, available in GMP-grade
- N1‑Methylpseudouridine-5’-Triphosphate, available in GMP-grade
- Customized purification processes
Analytical services for mRNA
TriLink’s in-house Analytical Services are powered by our Analytical Development, Qualification/Validation, and Quality Control teams with extensive expertise in nucleic acid characterization and analysis.
- Comprehensive methods to measure mRNA critical quality attributes (CQAs) including identity, integrity, potency, capping efficiency, impurities, and safety
- Analytical development services, such as construct-specific method development, qualification, and validation
- Streamlined transfer of validated methods to our in-house QC team for on-site release testing
Culture of Quality
TriLink is committed to achieving mRNA manufacturing quality metrics that meet or exceed customer and regulatory expectations. Our Quality Management System and team of quality experts ensure the highest level of consistency, purity, and comprehensive documentation.
TriLink’s commitment to quality includes:
- cGMP compliance with FDA regulations, in addition to ICH and other applicable guidelines
- Phase-appropriate Quality Management Systems
- Annual ISO 9001 audits, frequent customer audits, and an established internal audit program
- Comprehensive documentation and regulatory submission support
TriLink’s facilities meet the demands of mRNA manufacturing for each phase of development. Our new cGMP facility, opening in early 2024, has been designed by mRNA and regulatory experts to streamline late-phase clinical mRNA drug substance manufacturing.
Key facility attributes:
- 32,000 ft2 cGMP facility, opening in early 2024
- Three ISO 7 cleanrooms: 1,000 ft2 (93 m2) per suite of operational space
- Increased mRNA capacity (1g to > 100g per batch)
- On-site Quality Control and release testing
- Buffer prep and hold area
- Aseptic bulk aliquoting suite
- Single-use consumables and process flows designed for cGMP manufacturing
Let’s discuss your mRNA program needs!
Connect with our team of GMP mRNA manufacturing experts.