mRNA therapeutics are reshaping medicine, offering a fast, versatile way to develop vaccines and drugs. Usually made via scalable In Vitro Transcription (IVT, cell-free DNA-to-mRNA conversion), IVT can produce impurities like dsRNA that trigger strong innate immune responses—reducing these contaminants is key to clinical safety/efficacy and central to our services.
Our Custom mRNA IVT Synthesis Services tackle next-gen RNA therapeutic challenges. With advanced molecular engineering and a high-fidelity platform, they overcome immunogenicity bottlenecks, speed up clinic access, and deliver end-to-end production (sequence design to purified drug substance) with high yield, stability, minimal immunogenicity, and regulatory-ready analytical data.
In Vitro Transcription (IVT) synthesis, which is centered on simulating the in vivo transcription process, generates mRNA using DNA as a template in a cell-free in vitro system. It is the mainstream technology for producing long-chain mRNA (typically > 300 nucleotides) at present. With a wide range of applicable scenarios, it can be used for the synthesis of most linear mRNA and circular mRNA precursors, and enables large-scale production from milligram to gram levels, meeting the R&D and clinical needs of vaccines and therapeutic mRNA. The key advantages of this technology include the ability to synthesize longer mRNA sequences (up to over 10kb in length), the flexibility to introduce nucleotide modifications such as pseudouridine and N6-methyladenosine to reduce immunogenicity, as well as high yield and relatively controllable cost.
Fig.1 The five key structural components of IVT mRNA: 5 'terminal cap, lateral 5' and 3 'untranslated regions (UTR), open reading frame (ORF), and poly(A) tail.1,3
Custom saRNA Synthesis is the tailored production of short activating RNAs (saRNAs) with personalized designs (e.g., sequence optimization) to meet specific needs for targeted gene activation.
| Category | Specific Reagents/Raw Materials |
|---|---|
| Basic Synthetic Raw Materials |
Nucleotide Substrates (NTPs)
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| Key Reagents for Enzymatic Reactions |
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| Maturation Modification Reagents for Linear mRNA |
Capping-Related Reagents
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| Product Purification Reagents |
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| Auxiliary Reagents for Quality Control |
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Our services offer a distinct advantage over traditional methods by providing comprehensive control over every step of the IVT process. We specialize in eliminating the most problematic contaminants, such as dsRNA and abortive transcripts, through advanced purification and in-process analytics like AEX HPLC. This ensures that the final product not only meets but exceeds regulatory standards for safety and purity. Our expertise in sequence and structural optimization further enhances the stability and therapeutic potency of your mRNA.
We at Creative Biolabs are committed to providing a fully customized, start-to-finish solution for your mRNA needs, ensuring a product that is perfectly tailored to your project. Our dedication to quality and scalability means we can be your partner from initial discovery all the way to large-scale clinical manufacturing.
One-Stop Synthesis Service
From laboratory scale to pilot scale to full-scale manufacturing, we offer a seamless, one-stop solution for your entire project lifecycle.
Customized Process Development
Our team develops efficient, customized upstream and downstream processes to meet your specific requirements.
Scalable Production
With our large-scale synthesis capabilities and industrial-grade equipment, we can deliver a total production capacity of over 100,000 liters.
GMP-Certified Production
We adhere to the highest standards of quality, with a well-established quality system based on Quality-by-Design (QbD) and process analytical techniques (PAT), and strict GMP-certified synthesis.
Flexible Synthesis Modes
We can run the synthesis process in batch, fed-batch, or continuous modes, optimizing the conditions to maximize your yield.
Advanced QC Tools
Our high-standard quality control tools are designed to quantify and evaluate product quality, ensuring you receive a product of unmatched purity and integrity.
CGE-UV
Fig.2 By adding synthetic poly(A) length markers to the samples, the distribution and length of poly(A) tails can be determined using CGE-UV.2,3
SEC-UV and MS
Fig.3 The mRNA-related spectra obtained using ultra-large aperture chromatographic columns and mass spectrometry indicate the number of nucleotides and the percentages of monomers, dimers, and trimers.2,3
A: While kits are a great starting point for research, they often produce a mixture of full-length mRNA and immunogenic impurities like dsRNA. Our custom services go far beyond simple synthesis by providing a multi-step purification process and analytical QC that delivers a therapeutic-grade product with minimal contaminants, which is essential for preclinical and clinical applications.
A: Absolutely. We offer comprehensive design and optimization services that include codon optimization to increase translation efficiency, as well as the design of UTRs and the Poly(A) tail to improve mRNA stability and half-life. Our experts can collaborate with you to engineer a sequence that is optimized for your specific application.
A: Yes, our platform is designed for scalability. We use industry-standard purification techniques and process controls that are fully compatible with GMP (Good Manufacturing Practice) standards. We can take your project from the research and development stage all the way to large-scale clinical and commercial manufacturing.
A: We provide a comprehensive analytical QC report with every deliverable. We use a combination of techniques, including Capillary Electrophoresis (CE) to confirm the integrity of the full-length mRNA transcript and Anion Exchange HPLC (AEX HPLC) to quantify purity by separating and measuring the mRNA product from all other contaminants.
To learn more about how our Custom mRNA IVT Synthesis Services can accelerate your therapeutic development, please reach out to our team of experts. We are ready to discuss your specific project needs and provide a tailored solution.
Contact Our Team for More Information and to Discuss Your Project| Cat. No | Product Name | Promoter |
|---|---|---|
| CAT#: GTVCR-WQ001MR | IVTScrip™ pT7-mRNA-EGFP Vector | T7 |
| CAT#: GTVCR-WQ002MR | IVTScrip™ pT7-VEE-mRNA-EGFP Vector | T7 |
| CAT#: GTVCR-WQ003MR | IVTScrip™ pT7-VEE-mRNA-FLuc Vector | T7 |
| CAT#: GTVCR-WQ87MR | IVTScrip™ pT7-VEE-mRNA-Anti-SELP, 42-89-glycoprotein Vector | T7 |
| Cat. No | Product Name | Type |
|---|---|---|
| CAT#: GTTS-WQ001MR) | IVTScrip™ mRNA-EGFP (Cap 1, 30 nt-poly(A)) | Reporter Gene |
| CAT#: GTTS-WK18036MR | IVTScrip™ mRNA-Human AIMP2, (Cap 1, Pseudo-UTP, 120 nt-poly(A)) | Enzyme mRNA |
| (CAT#: GTTS-WQ004MR) | IVTScrip™ mRNA-Fluc (Cap 1, 30 nt-poly(A)) | Reporter Gene |
| (CAT#: GTTS-WQ009MR) | IVTScrip™ mRNA-β gal (Cap 1, 30 nt-poly(A)) | Reporter Gene |
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