mRNA
Revolutionary modality for future vaccines and therapeutics in undruggable areas
Overview
mRNA therapy is currently an active area of development, attracting worldwide attention for its therapeutic potential for the treatment of cancer, infectious diseases, and genetic disorders. Fujifilm provides end-to-end CDMO services including mRNA synthesis, LNP encapsulation using proprietary ionizable lipids, and Fill/Finish to meet the needs of pharmaceutical and biotech startup companies engaged in mRNA therapeutics.
mRNA Synthesis and Manufacturing
We apply a Design Of Experiment (DOE) process optimization approach that results in increased mRNA yield and purity, one of the main challenges in mRNA production.
Strategic alliances with TriLink BioTechnologies® and Synplogen® Co., Ltd. also enable optimization of mRNA sequence design, synthesis of plasmid DNA, and mRNA capping processes, streamlining mRNA-based therapeutics development.
Our dedicated team of experts develop custom and optimized in vitro transcription (IVT) protocols to meet your unique needs.
Proprietary IVT Protocols
- Scales ranging from microgram to multigram
- Compatible with long-chain mRNA (>10,000 nt)
*Template DNA is provided by customer
Scalable formulation design
- Design of Experiments (DOE) process optimization
- Customized LNP formulation and encapsulation of synthesized mRNA
- GMP manufacturing and purification equipment
mRNA Manufacturing Equipment
- Small- and medium-scale lines for a wide variety of products in small and commercial quantities
- Single-use equipment prevents cross-contamination and enables rapid multi-item production
Strategic Alliances
FUJIFILM Toyama Chemical has strategic alliances with TriLink BioTechnologies® for CleanCap® mRNA capping technology, and Synplogen® Co., Ltd. for mRNA sequence design and synthesis of plasmid DNA.
Analytical Services
Leading-edge analytical and quality control testing
- In-house comprehensive analytical methods following USP draft guidelines
- Pharmacological evaluations (protein expression, immune responsiveness)
Basic QC testing:
- RNA concentration (UV)
- RNA purity (Capillary electrophoresis)
Optional testing for critical quality attributes:
- Capping efficiency (after pretreatment, gel electrophoresis or LC-MS)
- dsRNA content (Dot blot assay)
- Residual template DNA (qPCR)
- Residual protein (Micro BCA™ protein assay)