The T7 RNA Polymerase GMP-grade (50 U/μL) is a highly purified enzyme designed for efficient and robust RNA synthesis. It is widely used in mRNA therapeutics, vaccine development, in vitro transcription, and RNA research applications. Manufactured under Good Manufacturing Practices (GMP), this enzyme ensures high-quality, consistent, and reproducible results, meeting stringent regulatory requirements.

Key Features and Benefits

• GMP-Grade Manufacturing: Ensures compliance with regulatory standards for biopharmaceutical applications.
• High Transcription Efficiency: Capable of generating high-yield RNA transcripts from linearized DNA templates.
• Ultra-Pure Enzyme: Free from RNase contamination, ensuring integrity and stability of synthesized RNA.
• Optimized for mRNA Production: Supports large-scale synthesis for mRNA vaccines and gene therapies.
• Scalable for Industrial Applications: Suitable for small- and large-scale bioprocessing.
• High Fidelity Transcription: Produces accurate and precise RNA molecules with minimal errors.
• Stable Enzyme Activity: Long shelf-life ensures consistent performance over time.

Mechanism of Action

T7 RNA Polymerase is a DNA-dependent RNA polymerase that specifically recognizes the T7 promoter sequence. Upon binding, it catalyzes the 5’→3’ RNA synthesis from the provided DNA template, efficiently transcribing long RNA molecules for various research and therapeutic applications.

The enzyme is particularly effective for:

• Linearized DNA templates with T7 promoter sequences.
• Incorporation of modified nucleotides for functional RNA molecules.
• High-yield RNA production for downstream applications in molecular biology and clinical research.

Applications

• mRNA Therapeutics: Used in the synthesis of custom RNA constructs for cancer therapy and rare genetic disorders.
• Vaccine Development: Essential for the large-scale production of mRNA vaccines against infectious diseases.
• RNA Probes and Aptamers: Generates high-quality RNA for diagnostic and molecular biology applications.
• Synthetic Biology: Enables high-fidelity RNA synthesis for gene expression and functional studies.
• CRISPR and RNA-Based Technologies: Produces guide RNAs for CRISPR-Cas gene editing and related applications.
• Enzymatic RNA Synthesis for Research: Supports transcription-based assays and sequencing workflows.
• Large-Scale Biopharmaceutical Production: Scalable for industrial RNA synthesis.

Performance Specifications

Storage and Stability

• Store at -20°C for long-term stability.
• Avoid repeated freeze-thaw cycles to maintain enzymatic activity.
• Use within recommended shelf-life for optimal RNA synthesis performance.
• Ensure enzyme integrity by proper handling and storage techniques.

Safety Considerations

• Handle under aseptic conditions to prevent contamination.
• Follow biosafety regulations when working with RNA synthesis components.
• Wear personal protective equipment (PPE) when handling enzyme solutions.
• Dispose of RNA waste according to biosafety protocols.

Protocol Guidelines

1. Template Preparation: Use linearized DNA templates with a T7 promoter for efficient transcription.
2. Reaction Setup: Combine T7 RNA polymerase, template DNA, NTPs, and buffer in optimized conditions.
3. Incubation: Perform transcription reaction at 37°C for 1-2 hours.
4. RNA Purification: Extract and purify RNA using appropriate protocols.
5. Quality Control: Validate synthesized RNA via spectrophotometry, agarose gel electrophoresis, or capillary electrophoresis.

Conclusion

The T7 RNA Polymerase GMP-grade (50 U/μL) is a high-performance, ultra-pure enzyme that supports large-scale RNA synthesis for biopharmaceutical, research, and diagnostic applications. Its GMP-grade manufacturing process ensures the highest standards of quality and consistency, making it an ideal choice for mRNA therapeutics, vaccines, and RNA-based technologies.

With its high efficiency, reliability, and compliance with regulatory standards, T7 RNA Polymerase GMP-grade is a preferred choice for scientists and biopharmaceutical developers working on cutting-edge RNA synthesis projects.

For standardized protocols and additional details, visit authoritative sources such as the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and National Science Foundation (NSF).