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Overview
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mRNA Therapeutics: Accelerating from Discovery to GMP Scale

mRNA technology is among the most transformative advances in modern biomedicine.However, transitioning from lab-scale success to commercial manufacturing remains a challenge due to inconsistent yields, dsRNA-induced immunogenicity, and complex QC validation.

Vazyme provides an integrated, end-to-end platform—combining engineered IVT enzymes with mechanism-driven optimization—to ensure your mRNA is simpler to produce, purer in quality, and ready for scale.

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Workflow

Precision Linearization: The Foundation of High-Quality mRNA 

A high-quality mRNA product begins with a flawless DNA template. Vazyme provides high-performance restriction enzymes specifically optimized for precise plasmid linearization, ensuring a clean and reliable starting point for subsequent IVT reactions.


Featured Solution: BspQ I (Type IIS Restriction Enzyme) 

  • Superior 3' Integrity: Utilizes Type IIS precision to generate intact, full-length poly(A) tails without unwanted sequence overhangs.

  • Robust Compatibility: Engineered to perform consistently across diverse plasmid workflows and complex residual matrices.

  • Rapid Processing: Highly efficient enzyme kinetics allow for complete and clean digestion within just 1 hour.

Featured Products

Magnetic Beads

Magnetic Beads

mRNA Production-related Enzymes

mRNA Production-related Enzymes

High-Fidelity IVT Synthesis: Maximize Yield, Minimize Impurities

Balancing high productivity with low immunogenicity is the hallmark of a successful IVT process. Vazyme offers a comprehensive suite of engineered T7 RNA polymerases—including wild-type and advanced mutants—specifically designed to suppress dsRNA formation, boost capping efficiency, and ensure transcript integrity. Our portfolio is supported by premium NTPs and essential auxiliary enzymes, including RNase Inhibitor, Inorganic Pyrophosphatase (IPP), and DNase I, ensuring a streamlined and high-performance workflow.


Featured Solution: T7 Turbo RNA Polymerase

  • Low dsRNA & Capping Cost

  1. Common IVT condition with 6mM GAG cap analog

  2. Cap analog reduction from 6mM to 1.5 mM (≤75%) without compromising capping rate, ideal for cost sensitive therapies 

  3. Maximum dsRNA reduction (~15-fold) using 6mM cap analog, ideal for dsRNA sensitive therapies, such as gene editing or protein replacement. WT-like CQAs: >90% full-length integrity, yields >8 mg/mL, A260/A280 = 1.8-2.0


  • Leads to Higher Protein Expression in vitro & in vivo


T7 Turbo drives markedly higher luciferase expression in BMDCs and in vivo (6h, 24h), across low-to-high mRNA doses.


Featured Solution: T7 CapMax RNA Polymerase

  • Dramatically reduce the cost of capping

T7 CapMax dramatically increases KdCap/KdNTP, enabling cap analog reduction from 5 mM to 0.25 mM (95%) ,no promoter G→A mutation needed. 


  • High Yield IVT System with CapMax

With High-Yield reaction buffer, T7 CapMax enables IVT yields up to ~25 mg/mL without increasing cap analog concentration, while maintaining RNA integrity and capping rate and significantly reducing dsRNA formation (~50%).


Featured Solution: T7 Pure RNA Polymerase

  • Best-in-Class dsRNA reducer

T7 Pure reduces dsRNA by ~100-fold vs WT across UTP and N1-ΨTP systems, while maintaining comparable mRNA integrity, capping rate, and yield.





Featured Products

Ensuring Purity and Regulatory Compliance

Rigorous quality control is the safeguard of clinical safety. Vazyme provides high-precision, ELISA-based analytical tools specifically developed to quantify critical residuals—including dsRNA, T7 RNAP, and DNase I—ensuring your final mRNA product meets stringent global purity standards.


Featured Solution: dsRNA Quantitative Detection Kit

  • Unbiased Accuracy: Engineered for consistent, length-independent quantification across various mRNA modifications, ensuring reliable results regardless of your sequence design. 

  • Exceptional Sensitivity: Achieves an industry-leading Limit of Quantitation (LOQ < 0.05 ng/ml), enabling the detection of trace impurities with peak precision. 

  • Gold-Standard Consistency: Fully validated for high correlation with J2-based Dot-Blot assays, allowing for a seamless transition to a more automated workflow. 

  • Operational Convenience: Ready-to-use, pre-coated ELISA kits streamline your QC process, enhancing throughput while maintaining superior batch-to-batch reproducibility.

Featured Products


Accelerating Delivery Validation 

Bridging the gap from synthesis to successful in vivo delivery requires rapid and reliable screening tools. Vazyme empowers your LNP and targeted LNP (tLNP) optimization with a versatile toolkit, including high-purity stock mRNA, reporter gene assays, and sensitive IgG detection kits—designed to streamline the evaluation of delivery efficiency and biological activity.


Featured Solution: Firefly Luciferase (FLuc) mRNA

  • Superior Expression Kinetics: Engineered for high-level protein expression, providing robust and measurable signals for accurate formulation screening.

  • Enhanced Structural Stability: Optimized to maintain integrity during the LNP encapsulation process, ensuring consistent results in both in vitro and in vivo models.

  • Ready-to-Use Convenience: Our stock mRNA eliminates the need for internal template design and IVT production, significantly shortening your LNP benchmarking timelines.

Featured Products


Resources

Learn more about our technologies to support antilbody drug discovery.Find the information you need in our educational materials database.

Application Cases

Proven Impact & Compliance — From Lab to Clinic


  1. The Challenge: A therapeutic developer needed to minimize dsRNA-induced immune responses during scale-up.

  2. Our Solution: By integrating Vazyme’s T7 Turbo RNA Polymerase and our optimized IVT process into their workflow.

  3. The Result: Reduced dsRNA impurities to below 0.01%, significantly mitigating unwanted cytokine induction. This transition ensured a safer, high-efficiency mRNA profile, paving a clear path for their clinical applications.



Commercial-Grade Reliability We bridge the gap between innovation and commercialization with a world-class infrastructure built for global compliance.


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  1. 10,000 m² state-of-the-art ISO 7-grade cleanrooms.

  2. Scalable production capacity with multiple lines ranging from 100 L to 5,000 L.

  3. Full lifecycle validation: URS, IQ/OQ/PQ/DQ, and FAT/SAT. 

  4. Strict Quality Management: * Our QMS is rigorously guided by international standards: NMPA GMP (2010), ICH Q7/Q9/Q10, and ISO 9001.



Items

Vazyme GMP-Grade Enzymes

AOF (animal origin free) and beta-lactam free process and materials

AOF and beta-lactam free facility

Manufacture and documentation follow ICH Q7 guidelines

Validated product-specific manufacturing processes and analytical methods

Product-specific stability

Impurity testing, including melamine and nitrosamine

DMF (drug master file)

Quality documentation

COA, COO, TSE/BSE statement, impurity profiles




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