Custom mRNA Synthesis Services
Introduction
Our Custom mRNA Synthesis service accelerates drug discovery via advanced in vitro transcription and strict QC, delivering high-quality, biologically active mRNA. Tailored to biopharmaceutical R&D, we provide precise, functional mRNA constructs for projects from early discovery to preclinical studies, driving innovation from concept to clinic.
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Custom mRNA Synthesis
Fig.1 Schematic diagram of the transcription and post-transcriptional processing of precursor mRNA.1,3
mRNA is a single-stranded RNA molecule that carries genetic information from DNA in the nucleus to the cytoplasm, where it serves as a template for protein synthesis. Its fundamental structure includes a 5' cap, untranslated regions (UTRs), a coding sequence (CDS), and a 3' poly(A) tail. Each of these elements plays a vital role in mRNA stability, translation efficiency, and immune recognition. The ability of mRNA to directly translate into proteins in the cytoplasm, without requiring nuclear entry, offers significant advantages over DNA-based therapies, including the elimination of insertional oncogenesis risks.
Workflow
Fig.2 The manufacturing and production process of mRNA includes DNA template sequence design and optimization, DNA template production and purification, mRNA synthesis through IVT, mRNA purification, and encapsulation.2,3
| Required Starting Materials | Upstream Process | Downstream Technology | Quantities |
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| The specific DNA sequence of the gene of interest (GOI) you wish to express |
Design and optimization of DNA template sequences Design the promoter (commonly the T7 promoter), the target gene (GOI), the 5' and 3' untranslated regions (UTR), and the poly (A) tail. |
Purity Assessment We perform comprehensive analyses to confirm the purity of the mRNA, ensuring minimal contamination from DNA, proteins, and other impurities. |
Identify required quantities, such as 50 nmol, 100 nmol, or 200 nmol. |
| Details regarding the desired mRNA length, scale, specific modifications, and purity requirements. |
Production and purification of DNA templates Design templates with T7 promoter, GOI, optimized UTRs, and poly(A) tail. Generate high-yield pDNA via bacterial fermentation, linearize, and purify. |
Integrity and Size Verification The integrity of the full-length mRNA transcript is verified using denaturing gel electrophoresis or capillary electrophoresis to confirm the correct size and minimize degradation. |
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mRNA Transcription Linear DNA template, T7 RNA polymerase, NTPs, Mg²⁺ (10-15 mM), buffer. |
Concentration Determination Accurate quantification of mRNA yield is performed using methods such as UV absorbance at 260 nm. |
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| Information on the intended use (e.g., in vitro studies, cell therapy, in vivo preclinical models) to help us optimize the synthesis and purification strategy. |
Biological Activity and Functional Testing Confirm the mRNA's ability to be translated into the desired protein in relevant cellular systems, ensuring biological activity. |
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| Custom Mitochondrial Targeting mRNA Synthesis |
Endotoxin and Bioburden Testing For preclinical and potential clinical applications, we ensure the mRNA product meets stringent endotoxin limits and is free from microbial contamination. |
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| Click for a full list of available modifications | |||
| Final Deliverables |
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| Estimated Timeframe | The typical timeframe for custom siRNA synthesis ranges from 5 to 10 business days, depending on the complexity of modifications, scale of synthesis, and specific quality control requirements. Our team will provide a precise timeline after reviewing your project specifications. | ||
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What We Can Offer?
At Creative Biolabs, we are dedicated to empowering your groundbreaking research and therapeutic development with unparalleled Custom mRNA Synthesis capabilities. Our commitment to excellence ensures that you receive mRNA products precisely tailored to your unique specifications, driving your projects forward with confidence.
Tailored mRNA Design and Optimization
Expert sequence design with codon optimization, precise UTR/poly(A) integration for enhanced expression, stability, and reduced immunogenicity.
Advanced Modifications & Capping
Expertise in incorporating modified nucleotides to minimize mRNA immunogenicity, paired with cutting-edge co-transcriptional capping technologies for high efficiency.
Minimization of Immunostimulatory dsRNA
Optimized synthesis/purification reduces dsRNA byproducts to ultra-low levels for safer therapeutic use.
Comprehensive Purification and Quality Control
Multi-stage chromatography (including HPLC for dsRNA) and strict QC ensure purity, integrity, and biological activity.
Dedicated Scientific Support
Experienced specialists provide end-to-end technical consultation, ensuring precise alignment with project needs.
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Customer Reviews
FAQ
How can the poly (A) tail length of mRNA be optimized to enhance translation efficiency?
The Poly (A) length can be designed based on the application scenarios of the product. In basic research, a tail length of 100-120 nt can balance stability and translation efficiency. If mRNA is to be used for vaccine development, it can be extended to 120-150 nt, which can prolong the half-life of the drug in the body. For different target cells, such as nerve cells, prefer a longer tail length (180-200 nt).
How to assess the impact of dsRNA impurities in synthetic mRNA on the immune response?
First, conduct quantitative detection: Use dsRNA-specific antibodies combined with ELISA, with impurities required to be less than 0.1%. Secondly, functional verification was conducted. Human peripheral blood mononuclear cells were stimulated in vitro to detect the secretion level of IFN-β. Finally, an animal model was used: serum IL-6 was detected 6 hours after tail vein injection in mice, and the IL-6 level in the dsRNA contaminated group could increase by more than 10 times.
When mass-producing mRNA, how can the truncated products during the transcription process be controlled?
When designing the template, the extension persistence of RNA polymerase can be enhanced by adding a 10 nt "GC clamp" sequence downstream of the T7 promoter. Secondly, adding 1 mM inosine triphosphate (ITP) to the reaction to replace part of GTP can reduce the transcriptional pause in the high GC region. In the purification step, affinity chromatography is used to specifically capture the full-length mRNA with poly (A) tails, which can remove 99% of the truncated products.
Our professional experts are eager to discuss your specific project requirements and provide tailored solutions. We are committed to supporting your journey from discovery to therapeutic development with our cutting-edge Custom mRNA Synthesis services.
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References
- Sharma, Yashica, et al. "mRNA Transcript Variants Expressed in Mammalian Cells." International Journal of Molecular Sciences 26.3 (2025): 1052. DOI: 10.3390/ijms26031052
- Youssef, Maryam, et al. "Enabling mRNA therapeutics: Current landscape and challenges in manufacturing." Biomolecules 13.10 (2023): 1497. DOI: 10.3390/biom13101497
- Distributed under Open Access license CC BY 4.0, without modification.