Ultra Nuclease, GMP Grade (DMF No.: MF036352): High-Performance Endonuclease for Nucleic Acid Removal in Biomanufacturing
Source: Hzymes Market Center
Date: 2025-10-10
Views: 1227

Overview


Ultra Nuclease (GMP Grade) is a high-purity endonuclease enzyme designed to efficiently degrade all forms of DNA and RNA in bioprocessing and viral vector production. With a DMF filing (No. MF036352) and GMP-compliant manufacturing, it ensures exceptional reliability, safety, and regulatory readiness for biopharmaceutical and gene therapy workflows.


The enzyme hydrolyzes phosphodiester bonds in nucleotides, completely digesting free nucleic acids. Structurally, Ultra Nuclease consists of two subunits (~30 kDa each) with an isoelectric point (pI) of 6.85, offering balanced activity and stability under process conditions.


 

Key Applications


Efficient nucleic acid removal is critical in biomanufacturing, where residual DNA or RNA can affect product purity, safety, and downstream processing. Ultra Nuclease delivers superior performance across multiple applications:


Viral Vaccine and Vector Purification


Efficiently removes host-cell DNA and RNA from viral vaccines, adenovirus, AAV, and lentivirus production.


Cell and Gene Therapy Manufacturing


Supports GMP-grade purification of viral and non-viral gene therapy vectors, improving downstream efficiency and compliance.


Particle Pretreatment


Removes nucleic acids wound around viral particles, facilitating virus release and purification.


Viscosity Reduction


Eliminates nucleic acids in crude extracts, reducing viscosity and improving protein yield.


PBMC Storage Optimization


Reduces cell clumping in stored peripheral blood mononuclear cells, enhancing culture stability.

 


GMP Compliance and Quality Assurance


Ultra Nuclease is manufactured under GMP conditions in strict accordance with regulatory standards.


✅ No antibiotics used during production
✅ Free from TSE/BSE-risk materials
✅ No raw materials of animal origin
✅ Documented Drug Master File (DMF No. MF036352)


These assurances make it suitable for clinical-grade biopharmaceutical production and regulatory submissions worldwide.

 


Product Features


  • High Specific Activity ≥ 1.0 × 10⁶ U/mg
  • Excellent Stability — thermal and freeze-thaw resistant
  • Batch Consistency — inter-batch CV < 5%
  • Animal Origin-Free — ideal for sensitive therapeutic applications
  • DMF-Filed — supports global regulatory compliance

 


Performance Data


 


Quality Data


 


Application


Compared under the same enzyme activity



Comparison of plasmid digestion ability under same enzyme activity across different manufacturers: Plasmid digestion ability: Hzymes’s Super Ultra Nuclease > Competitor B > Competitor A.

 

Compared at the same volume



Comparison of plasmid digestion ability at the same volume across different manufacturers: Plasmid digestion ability: Hzymes’s Super Ultra Nuclease > Competitor B > Competitor A.

 

Viscosity reduction in bacterial suspension

 

 

 


Why Choose Hzymes Ultra Nuclease (GMP Grade)?



  •        GMP-Certified Production ensures batch-to-batch consistency
  •        DMF-Filed (MF036352) for smooth regulatory filing
  •        Cost-Effective and Scalable for commercial biomanufacturing
  •        Validated in Viral Vector and Vaccine Production
  •        Reliable Supply Chain from a trusted global enzyme manufacturer


 

Conclusion


As nucleic acid contamination control becomes a key quality requirement in vaccine, gene therapy, and biopharmaceutical manufacturing, Hzymes Ultra Nuclease (GMP Grade) delivers a robust, regulatory-ready solution. Its high activity, excellent stability, and GMP compliance make it the preferred choice for next-generation bioprocessing workflows.

 

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Service Hotline: +86 400-808-5320

Large-scale production base: Building 6, Precision Medical Industry Base, Wuhan, China

Logistics & Supply Chain Center:417 Main St, Little Rock, AR 72201. United States.

Global Marketing Center: Hzymes Building, Fengxian District, Shanghai, China.

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Service Hotline: +86 400-808-5320

Large-scale production base: Building 6, Precision Medical Industry Base, Wuhan, China.

Logistics & Supply Chain Center:417 Main St, Little Rock, AR 72201. United States.

Global Marketing Center: Hzymes Building, Fengxian District, Shanghai, China.

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