Nucleic Acid Quality & Detection

Introduction

As mRNA vaccines and therapeutics revolutionize medicine, ensuring purity and safety at every step of the manufacturing process is more important than ever. One of the biggest challenges in this field is managing process-related impurities—specifically dsRNA contaminants, and residual enzymes such as DNase I, RNase inhibitors, and inorganic pyrophosphatases.

To address these challenges, AffiGEN’s AffiELISA® kits offer a suite of reliable, sensitive, and easy-to-use ELISA assays designed for precise quality control in biopharmaceutical production workflows.

Why Is dsRNA a Concern in mRNA Therapeutics?

During in vitro transcription (IVT), synthetic mRNA is produced using enzymatic reactions. However, double-stranded RNA (dsRNA) a by-product of IVT can form unintentionally. Even trace amounts of dsRNA can :

• Trigger unwanted innate immune responses
• Reduce translation efficiency
• Compromise patient safety

Regulatory agencies such as the EMA and FDA require robust detection and removal of dsRNA during mRNA drug production.

The AffiELISA® RIG-I dsRNA ELISA Kit is designed to detect dsRNA using the innate immune receptor RIG-I as the capture agent offering high specificity and relevance for therapeutic applications.

The Role of Enzyme Detection in QC
Enzymes used in mRNA synthesis like DNase I, RNase inhibitors, and inorganic pyrophosphatases are crucial for reaction efficiency and stability. However, their residual presence in the final product can:

• Lead to mRNA degradation
• Alter reaction kinetics
• Compromise batch-to-batch reproducibility

🔍 AffiELISA® Offers the Following Kits :

• DNase I ELISA Kit :  Ensures efficient removal of DNA-processing enzymes post-IVT.
• RNase Inhibitor ELISA Kit : Verifies the presence or absence of RNase-blocking agents.
• Inorganic Pyrophosphatase ELISA Kit : Monitors enzyme purity that affects transcription efficiency.

These kits are ideal for process optimization, release testing, and regulatory compliance in mRNA and gene therapy production pipelines.

Why Choose AffiELISA® for Biopharma QC?

🧪 High specificity with sandwich ELISA format

⏱️ Rapid workflow (2–3 hours)

🧬 Validated for mRNA drug pipelines

📊 Quantitative results suitable for GMP documentation

Each kit is compatible with routine plate readers and requires no specialized equipment—making integration into biotech QC labs seamless and cost-effective.

Conclusion
As the mRNA field continues to grow, quality control will remain a cornerstone of safe and effective therapeutic production. Tools like AffiELISA® kits empower scientists and manufacturers to meet the highest standards of integrity, purity, and safety.

Whether you're developing the next mRNA vaccine or optimizing a new therapeutic, AffiGEN’s ELISA solutions are here to detect what matters most.