Messenger RNA (mRNA) therapeutics and vaccines are cornerstones of modern medicine—they let the body make its own therapeutic proteins or immunogenic antigens. But their success hinges on the quality of synthetic mRNA: published data show impurities like dsRNA can rev up the innate immune system, hurting both safety and effectiveness. That's why a strong, precise synthesis platform is so important—and our services are designed to tackle this need head-on, making sure quality is never compromised.
Creative Biolabs' Custom mRNA Synthesis Services speed up drug discovery by delivering high-quality, ultra-pure mRNA through a smooth, end-to-end solution. Driven by high-fidelity IVT technology and thorough quality control, these services solve key challenges like long production timelines, expensive purification costs, and worries about immunogenicity.
Discover How We Can Help - Request a ConsultationWe offer a comprehensive range of services tailored to your specific needs, from early-stage research to late-stage clinical development.
This process is utilized for generating smaller mRNA fragments, typically a few hundred nucleotides in length. It is particularly well-suited for applications that require extremely high precision, such as the synthesis of short guide RNAs (gRNAs) for CRISPR-Cas systems or specialized regulatory RNAs for gene editing. The method offers superior control over nucleotide incorporation and modification, providing a highly defined product that is ideal for sensitive research applications where every base matters.
Fig.1 Chemical modifications of mRNA and RNA modifiers.1,3
Custom mRNA IVT Synthesis (in vitro transcription synthesis) can efficiently synthesize long-chain functional mRNAs with thousands of nucleotides. This ability makes it widely used in mRNA drugs (such as protein replacement therapy) and mRNA vaccine development. This technology can achieve precise control over nucleotide inclusion and modification, and can produce highly sequence-clear products. It can meet the requirements whether it is used in sensitive research where base sequences are crucial or in preclinical development that needs to ensure the structural and functional integrity of full-length mRNA.
Quality is paramount throughout our entire process. We adhere to a stringent, multi-stage quality control program to ensure every batch of mRNA meets the highest standards for purity, integrity, and concentration. Our comprehensive analysis includes:
Our streamlined workflow is designed for efficiency and transparency, ensuring you are fully informed at every stage of your project. The process begins with your initial project design and culminates in the delivery of a fully characterized and ready-to-use mRNA product.
To start the project, clients typically provide a linearized DNA template (or its sequence for synthesis), target mRNA sequence, and details of desired modifications or capping strategies.
Our scientific team reviews your requirements collaboratively, aiding sequence optimization/design to boost expression, stability, and translational efficiency for a solid project foundation.
We synthesize high-purity DNA templates and conduct high-fidelity IVT reactions, with optimized processes minimizing immunogenic dsRNA impurities from the start.
Post-transcription, products undergo rigorous purification to remove template DNA, enzymes, and by-products; enzymatic capping/tailing is then done for maximum mRNA stability and functionality.
Purified mRNA goes through strict QC: techniques like mass spectrometry, gel electrophoresis, and concentration assays confirm its purity, integrity, and quantity.
We package and ship the final mRNA product with all supporting documentation, including the Certificate of Analysis (CoA) and a detailed project report.
Upon project completion, you will receive your purified mRNA product, a detailed Certificate of Analysis (CoA) confirming key quality metrics, and a comprehensive project summary report that includes all raw data and analysis.
The typical timeframe for this service ranges from 4 to 8 weeks, depending on the complexity of the target sequence, the scale of production, and any required modifications.
Our Custom mRNA Synthesis Services are designed to provide a comprehensive, flexible, and high-quality solution for every stage of your project, from basic research to clinical trials. We offer an unparalleled level of customization and support to ensure your specific needs are met with scientific precision.
One-stop service for high-quality mRNA from milligram-scale research to multi-gram clinical batches.
Efficient upstream process development and sequence optimization for enhanced expression and stability.
High-fidelity In Vitro Transcription (IVT) platform to minimize immunogenic dsRNA impurities at the source.
Flexible and customizable nucleotide modification and capping strategies, including co-transcriptional and enzymatic methods.
A well-established, multi-stage quality system with analytical techniques like mass spectrometry and gel electrophoresis for guaranteed purity and integrity.
Dedicated technical support from our team of biology experts to guide you at every step of your project.
Streamlined, end-to-end workflow to accelerate your project from concept to final deliverable.
Capillary Electrophoresis Analysis
Fig.2 The proportion of the target mRNA in the total synthesized mRNA was detected by capillary electrophoresis.2,3
mRNA Integrity and Products
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: The timeframe for each project varies depending on its complexity, scale, and specific modification requirements. We invite you to schedule a consultation with our scientific team to discuss your project details and receive a more accurate and personalized estimate.
A: Our core approach involves a high-fidelity In Vitro Transcription (IVT) platform designed to minimize the formation of dsRNA and other impurities at the source. This is complemented by our rigorous, multi-stage quality control process, which includes mass spectrometry and gel electrophoresis, to guarantee an exceptionally clean final product.
A: Yes, our platform is built for scalability. We can produce mRNA from milligram-scale research quantities to multi-gram batches suitable for pre-clinical and clinical trial use, ensuring a seamless and reliable supply chain for your entire development pipeline.
A: We offer a wide range of nucleotide modifications, including Pseudouridine and other proprietary analogs, as well as multiple capping strategies. We can assist you in selecting the optimal modifications for your therapeutic application to enhance stability and translational efficiency.
A: Our services provide a cost-effective alternative to in-house production by eliminating the need for extensive equipment, expertise, and time-consuming process development. Unlike other providers who may rely on traditional methods, our focus on high-fidelity IVT significantly reduces impurities, saving you both time and money on downstream purification.
Creative Biolabs is your trusted partner for high-quality Custom mRNA Synthesis Services. We are ready to help you accelerate your research and development with our advanced platform. Our team of experts is available to discuss your specific needs and provide a tailored solution.
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This article details a method to produce synthetic mRNA with reduced immunogenicity using high-temperature in vitro transcription (IVT) with thermostable T7 RNA polymerases. The study identifies two types of double-stranded RNA (dsRNA) by-products that trigger immune responses: one from 3'-extension of run-off products and another from antisense RNA formation. The researchers demonstrate that high-temperature IVT reduces 3'-extension without affecting antisense RNA by-products. Additionally, incorporating a poly(A) tail in the template DNA decreases antisense RNA formation. This approach simplifies mRNA synthesis, potentially eliminating the need for post-synthesis purification to remove immunogenic dsRNA. Creative Biolabs has established a specialized technology platform for mRNA synthesis, which can address various issues in mRNA synthesis.
Fig.1 Agarose gel analysis results of 3'-extended RNA.1
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