uBriGene’s GMP mRNA-LNP manufacturing platform delivers high-quality, high-potency mRNA and LNPs using our novel LNP microfluidic technologies.
uBriGene Biosciences leverages advanced mRNA in vitro transcription technology and optimized platform-based production, offering services from plasmid DNA template preparation to bulk mRNA production and mRNA-LNP formulation.
By partnering with us, we can help fast track your RNA therapeutics from concept to clinic.
With our highly productive GMP mRNA manufacturing platform and RNA-LNP formulation technologies, we can accelerate your mRNA therapeutic and vaccine programs.
Integrated services, from plasmids to RNA-LNP
Customer focused partnership
We offer a comprehensive range of GMP mRNA manufacturing solutions, including precise mRNA modifications, capping, and tailing, all tailored to ensure optimal performance for your therapeutic candidates.
Our GMP mRNA-LNP CDMO services include process and analytical development, technical transfer, GMP manufacturing, stability testing, product release, and regulatory support. Additionally, we provide high-throughput RNA-LNP screening services to identify the best LNP formulations for your therapeutic programs.
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Request a quoteAs a leader in mRNA technology, uBriGene provides end-to-end solutions that drive innovation in RNA therapeutics development. Our cutting-edge platforms ensure seamless integration from plasmid synthesis to mRNA-LNP formulation, accelerating the commercialization of mRNA therapeutics.
We also offer high-throughput RNA-LNP screening services to identify the optimal LNP formulation for your therapeutic programs.
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Request a quoteuBriGene also provides cell banking services for GMP plasmid manufacturing. Full quality release assays and stability studies will be performed in house. PCB, MCB and WCB are established to meet Investigational New Drug application standards. View details at Cell Banking Services page.
Our GMP plasmid manufacturing platform is optimized for quality and yield. The closed and continuous alkaline lysis system ensures a high level of sterility and compliance with regulatory standards.
The lysates are clarified through scalable, fully closed depth filtration, followed by a cost-effective two-step purification process using anion exchange (AEX) and hydrophobic interaction chromatography (HIC). For larger-scale production membrane matrix chromatography allows for higher flow rates.
The advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
Our team develops robust analytical methods to ensure product quality, consistency, and compliance with GMP standards. This includes in-process testing, characterization of mRNA, and quality control of the lipid nanoparticle formulation.
| Test Items | Method | |
|---|---|---|
| Identity | mRNA sequence identity | RT-PCR+Sanger Sequencing |
| Content | Concentration | UV absorbance |
| Purity | 5’ capping efficiency | CE/LC-MS |
| 3’ polyA tail length | CE/LC-MS | |
| A260/A280 | UV absorbance | |
| RNA integrity | HPLC | |
| mRNA fragments | ||
| Aggregate quantitation | ||
| Residual protein | Qubit / MicroBCA | |
| dsRNA | ELISA | |
| Residual DNA template | qPCR | |
| Residual solvents | Residual ethanol（GC-MS） | |
| Potency | Expression of target protein | Cell-based assay |
| Safety | Sterility | Culture method |
| Endotoxin | GEL-CLOT Method | |
| Physical/chemical Properties | Appearance | Visual method |
| pH | pH | |
| Test Items | Method | |
|---|---|---|
| Identity | Identity of lipids | RP-HPLC |
| Integrity | LNP size and polydispersity | Dynamic light scattering (DLS) |
| Content | Concentration | Fluorescence-based assay |
| Purity | Aggregate quantitation | SEC-HPLC |
| Encapsulation efficiency | Fluorescence-based assay, | |
| Residual solvents | Residual ethanol | |
| Potency | Expression of target protein | Cell-based assay |
| Safety | Sterility | Culture method |
| Endotoxin | GEL-CLOT Method | |
| Physical/Chemical Properties | Appearance | Visual method |
| pH | pH | |
| Osmolality | Osmolality | |
| Subvisible particles | Light blockage methods | |
| Extractable volume | Volumetric method | |
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Agarose gel electrophoresis of mRNA IVT samples before and after chromatography purification.
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NeonGreen mRNA lipid nanoparticles were added to activated human primary T cells, in the presence of 1X serum-free enhancer A (uBriGene). Fluorescence images were captured 24 hours after treatment. The left image shows fluorescence, while the right image shows the phase contrast.
Request a quoteDiscover our GMP mRNA manufacturing capabilities and QC testing.
Learn about CAR-T production process & regulatory guidelines.
Discover our GMP plasmid manufacturing process and testing.
Explore our GMP iPSC production platform, powered by our efficient RNA-LNP reprogramming cocktail.
We can provide GMP mRNA-LNP ranging from 100 µg to several grams of mRNA encapsulated in LNP.
We utilize proven mRNA-LNP formulations from the Moderna and Pfizer COVID vaccines, as well as novel lipids developed by our collaborators. Specific formulation processes can also be transferred to us by clients. We can provide LNP formulation studies to find the optimal condition for your projects.
With our robust mRNA downstream purification process, dsRNA impurity levels are below 0.1% (w/w).
uBriGene provides integrated GMP mRNA-LNP manufacturing services, with an established GMP plasmid production platform. We have successfully delivered over 300 GMP plasmid batches.
Extensive expertise with a track record of successfully releasing over 20 GMP batches of mRNA-LNP.
Cost-effective
Reduced timeline
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
