Our GMP saRNA-LNP manufacturing platform produces high-quality, potent saRNA and LNPs, accelerating the development of RNA therapies and vaccines.
uBriGene’s talented technical and regulatory teams have extensive experience in the GMP manufacturing and releasing self-amplifying RNA (saRNA) to support RNA therapies and vaccines. Our advanced LNP encapsulation technology ensures high encapsulation rate and well-controlled LNP size.
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With our highly productive GMP saRNA manufacturing platform and RNA-LNP formulation technologies, we can accelerate your RNA therapeutic and vaccine programs.
Integrated services, from plasmids to RNA-LNP
Polycistronic options
uBriGene has developed 293XS, a proprietary high-yield AAV suspension production cell line. The suspension AAV production platform is serum free and animal component free. The advantage of suspension production cell lines in GMP AAV manufacturing is the scalability, much easier to scale up.
Our fully qualified 293XS cell bank is specifically selected for its exceptional productivity and quality in AAV vector manufacturing, helping to reduce costs for your clinical therapeutic programs.
Serum-free, animal component free
Good Growth at density of 1E7 cells/mL
High AAV productivity, 1E14 vg/L
DMF on file with the FDA
GMP AAV production received FDA IND clearance
Scalable AAV production up to 2,000 L
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.
As a leader in saRNA technology, uBriGene delivers comprehensive solutions that foster innovation in RNA therapeutics development. Our advanced platforms enable seamless integration from plasmid template production to saRNA-LNP formulation, expediting the path to commercialization for RNA therapies.
uBriGene’s polycistronic saRNA enables the expression of multiple therapeutic genes from a single self-amplifying saRNA molecule. Additionally, we provide high-throughput RNA-LNP formulation studies to help identify the most effective LNP formulations for your therapeutic programs.
Diagram of uBriGene’s comprehensive AAV CDMO Services
Request a quoteThe integrated saRNA-LNP quality control and analytical testing within this platform guarantees that each batch meets the highest standards, ensuring safe and reliable therapeutic solutions for patients.
| Test Item | 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 | |
*Outsourced testing
| Test Item | 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 | |
*Outsourced testing
In our polycistronic saRNA design, multiple genes of interest (GOIs) can be expressed independently and in their native form, without the addition of extra amino acid sequences. The protein expression levels of the GOIs are identical.
This polycistronic saRNA could be beneficial for therapeutic programs requiring the expression of more than one protein.
Fig. 1. High-quality GMP AAV9 with a high percentage of full capsids produced. A 2-step chromatographic purification process for AAV9 was performed following 200L upstream production. High-purity AAV9, including both full and empty capsids, was purified using affinity chromatography. AAV9 full capsids were enriched through AEX chromatography, achieving 85% full capsids, as measured by the analytical ultracentrifugation (AUC) method.
Fig. 2. AAV full/empty capsid ratio measured by AUC method.
Note: The same amount of saRNA and mRNA were used in this experiment. Due to its larger size, the molar concentration of saRNA is significantly lower compared to linear mRNA.
The polycistronic saRNA contains NeonGreen and RFP expression cassettes. The same amount of saRNA and mRNA (1ug, respectively) were transfected into HEK293 cells using PEI. Fluorescence images were captured 72 hours post transfection.
Lipid nanoparticles containing NeonGreen-teLuc saRNA, circRNA, and linear mRNA (1 pmol / 1E5 cells) were added to HEK293 cells, and Bioluminescence quantification was performed up to 16 days post-treatment.
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saRNA, or self-amplifying mRNA, is engineered to contain the gene of interest and all essential elements allowing self-amplification of the saRNA. Its ability to replicate within cells allows saRNA vaccines to achieve the same immune response as traditional mRNA vaccines but with a much lower initial RNA dose. Using saRNA at a lower dose reduces the cost and potential side effects compared to other RNA-based therapies.
Our saRNA can be delivered in single tubes, suspended in nuclease-free water (1 mg/ml). The saRNA-LNP can be delivered in single tubes, suspended in Tris-buffer or PBS (0.1 mg/ml, RNA concentration).
Typically, saRNA ranges from 8K to 13K nucleotides in length, but longer sequences can be produced if necessary.
uBriGene provides end-to-end saRNA manufacturing services, supporting both research-grade and full GMP saRNA production. With our advanced microfluidic LNP technologies, we can produce batch-to-batch consistent, high-quality RNA-LNP with an encapsulation rate of nearly 100%.
Due to its longer length compared to mRNA, achieving high purity in saRNA is a major challenge in saRNA manufacturing. uBriGene can provide high-quality saRNA with purity levels of up to 80%.
Yes, uBriGene can carry out LNP formulation studies, testing various lipids, components, and cell culture conditions to identify the most efficient delivery method for your target cells.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of AAV.
AAV suspension production cell bank
Streamlined platform-based processes
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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.
