T7 RNA polymerase is a core component in in vitro transcription (IVT) systems, responsible for synthesizing high-yield mRNA from DNA templates with a T7 promoter sequence. As mRNA-based therapies and vaccines continue transforming global healthcare, the demand for high-performance, GMP-grade T7 RNA polymerase is at an all-time high.

Hzymes Biotech rises to this challenge with a robust enzyme portfolio, including both wild-type and 30+ engineered T7 RNA polymerase mutants, tailored to meet diverse pharmaceutical manufacturing needs.

What Is T7 RNA Polymerase and Why Is It Critical?

T7 RNA polymerase is a DNA-dependent RNA polymerase derived from bacteriophage T7. In IVT applications, it recognizes and binds to the T7 promoter to initiate RNA synthesis, producing high levels of mRNA rapidly and efficiently.

This enzyme is foundational in:

• mRNA vaccine production

• Gene and cell therapy

• Synthetic biology

• Personalized medicine

However, not all T7 RNA polymerases are created equal. Clinical and GMP manufacturing demand enzymes with high fidelity, minimal by-products like dsRNA, and excellent thermal stability.

Hzymes’ T7 RNA Polymerase Portfolio: Engineered for Precision and Performance

Hzymes Biotech offers a comprehensive suite of T7 RNA polymerases for research and pharmaceutical use, including:

1. Wild-Type T7 RNA Polymerase

• Maintains natural activity and fidelity.

• Validated by Sanger sequencing to ensure no significant fidelity loss.

• Ideal for standard mRNA synthesis processes.

2. Engineered Mutant T7 RNA Polymerases

Each engineered variant targets a specific challenge in IVT and mRNA production:

🧬 High mRNA Integrity Mutant 
Enhances full-length transcript integrity for therapeutic applications.

🧬 Low dsRNA Mutant13 
Minimizes double-stranded RNA contamination, reducing innate immune responses and enhancing mRNA vaccine safety.

🧬 Thermostable Mutant 
Performs efficiently at elevated temperatures, ideal for long or structured RNA templates.

These enzymes are plug-and-play for high-efficiency IVT platforms and can significantly improve product yield and quality.

GMP-Grade Manufacturing and Global Compliance

All of Hzymes’ pharmaceutical-grade enzymes are produced under strict Good Manufacturing Practice (GMP) conditions:

✅ Animal-Origin-Free (AOF) Raw Materials
Ensures biosafety and regulatory compliance.

✅ DMF Record Available: MF036856
Supports regulatory filings in the US and other jurisdictions.

✅ Custom Packaging and Documentation
Suitable for CDMOs, biotech firms, and pharmaceutical manufacturers.

Multi-dimensional quality control standard to ensure good consistency between batches and to secure the successful application in pharmaceutical industry.

Multi-Dimensional Quality Control: Consistency You Can Trust

Hzymes implements an industry-leading QC strategy, including:

• Activity testing

• Fidelity analysis (Sanger sequencing)

• dsRNA contamination profiling

• Host protein and DNA residue screening

• Endotoxin and sterility checks

With CV <15% across batches, customers benefit from reproducible results and stable process performance — crucial for scale-up and tech transfer.

Why Choose Hzymes Biotech?

With deep roots in mRNA technology, synthetic biology, and enzyme engineering, Hzymes Biotech has helped numerous clients move from R&D to clinical and commercial production.

Highlights include:

• 30+ T7 RNAP variants ready for deployment.

• Custom enzyme development available.

• Strong support for regulatory documentation and DMF access.

Conclusion: Your Trusted Partner in mRNA Enzyme Manufacturing

Whether you're producing mRNA vaccines, cell therapies, or advanced biologics, Hzymes Biotech’s GMP-grade T7 RNA polymerase line offers reliability, flexibility, and compliance at scale.