GMP mRNA-LNP Manufacturing Services

We can provide GMP mRNA-LNP ranging from 100 µg to several grams of mRNA encapsulated in LNP. 

uBriGene can work with established mRNA-LNP formulations, novel lipid systems, or client-provided formulations transferred for development and manufacturing. uBriGene also provides LNP formulation development and high-throughput screening to identify suitable formulation conditions for specific mRNA programs. Formulation parameters are optimized according to the mRNA payload, lipid composition, and intended application.

With our robust mRNA downstream purification process, dsRNA impurity levels are below 0.1% (w/w).

No. uBriGene can provide GMP plasmid templates as part of its integrated mRNA-LNP manufacturing services, covering plasmid template preparation, mRNA production, and LNP formulation. uBriGene has an established GMP plasmid production platform and has successfully delivered more than 300 GMP plasmid batches.

uBriGene supports GMP mRNA-LNP programs through GMP manufacturing, analytical testing, stability studies, product release, technical transfer, and regulatory support. Its U.S. and Asia facilities support global cell and gene therapy programs, and the Germantown, Maryland facility maintains active FDA DMF #31266. Products tested at the site have also supported FDA IND clearances.

uBriGene's GMP mRNA manufacturing workflow can span GMP plasmid template preparation, in-vitro transcription (IVT), mRNA purification, analytical testing, LNP encapsulation, and aseptic fill and finish. The integrated platform also supports process and analytical development, technology transfer, stability testing, product release, and regulatory support for mRNA-LNP programs.

uBriGene's GMP mRNA QC program evaluates identity, concentration, 5′ capping efficiency, poly(A) tail length, RNA integrity, mRNA fragments, aggregates, dsRNA, residual DNA template, residual protein, residual solvents, potency, sterility, and endotoxin. LNP testing includes lipid identity, particle size and polydispersity, concentration, encapsulation efficiency, residual solvent, potency, sterility, endotoxin, pH, osmolality, subvisible particles, and extractable volume. The final testing panel is tailored to the product and development stage.

uBriGene's GMP mRNA manufacturing process achieves over 90% mRNA purity, with the platform page reporting nearly 100% purity under its stated production conditions. Its microfluidic LNP encapsulation process achieves over 90% encapsulation efficiency. Actual product performance depends on the mRNA sequence, formulation, process conditions, and analytical method.

Yes. uBriGene provides integrated GMP mRNA-LNP manufacturing from plasmid DNA template preparation and mRNA IVT through purification, LNP formulation, analytical testing, and aseptic fill and finish. Services also include process and analytical development, technology transfer, stability testing, product release, and regulatory support.