Overview of UltraNuclease

UltraNuclease, also known as universal nuclease or broad-spectrum nuclease, is a non-specific endonuclease derived from Serratia marcescens. It cleaves nucleic acids between any nucleotides within a strand, completely digesting them into 5'-monophosphate oligonucleotides of 2–5 base pairs. This enzyme degrades all forms of DNA and RNA—double-stranded, single-stranded, linear, circular, native, or denatured—making it indispensable for removing nucleic acids from biological products.

Expressed and purified in Escherichia coli (E. coli) through genetic engineering, UltraNuclease is manufactured under GMP conditions. It serves multiple purposes, including reducing the viscosity of cell supernatants and lysates to enhance protein purification and functional studies. Additionally, it is widely used in viral purification, vaccine production, and pharmaceutical industries (e.g., protein- and polysaccharide-based therapeutics), where it reduces host residual nucleic acids to picogram (pg) levels, improving the safety and efficacy of biologics.

YEASEN Bio offers both UltraNuclease and the UltraNuclease Residual Detection Kit. These products have completed Drug Master File (DMF) filing and are manufactured under the ISO 13485 quality system, meeting stringent regulatory requirements for drug registration. They have successfully supported multiple clients in completing Investigational New Drug (IND) application submissions.

Application Scenarios

• Biologics Purification: Removes exogenous nucleic acids from vaccines and recombinant proteins.
• Viral Particle Processing: Eliminates residual nucleic acids on the surface of viral particles (e.g., AAV, LV) to enhance purification efficiency.
• NGS Sample Preparation: Pretreats next-generation sequencing (NGS) samples by removing human-derived nucleic acids, improving sample purity and sequencing accuracy.
• Viscosity Reduction: Reduces viscosity in protein and cell lysates, preventing cell clumping during processing.

Product Advantages

• Regulatory Compliance: Completed DMF filing and produced under GMP-grade standards within the ISO 13485 quality system.
• High Activity: Specific activity ≥1.5×10⁶ U/mg, ensuring rapid and efficient nucleic acid degradation.
• Superior Quality: Matches the efficacy of leading competitor products (e.g., Company M), serving as a reliable alternative.
• Proven Success: Trusted by multiple clients for successful IND project submissions.

 Rigorous Quality Control and Production Standards

Detection Items	Quality Standards	Detection Method
Enzyme Activity	250–300 U/μL	Universal substrate method
Specific Activity	≥1.5×10⁶ U/mg	Universal substrate method
Protein Purity	≥99%	SDS-PAGE
Protease	Meets requirements	Universal substrate method
Bacterial Endotoxin	Meets requirements	Gel method
Host Protein	Negative	ELISA method
Host DNA	Negative	qPCR method
Sterile Testing	Sterile growth	General Rule 1101
Pathogen Detection	Negative (not detected)	Internal method
Mycoplasma Testing	Negative (not detected)	Internal method
Heavy Metal Testing	Meets requirements	General Rule 0821

Product Data

Temperature&pH
High activity across 4–42°C	High activity across Ph6-10

Salt ion concentration
High activity up to 150 mM	High activity up to 10 mM Mg2+	Tolerant to 40 mM of PO₄³⁻

Surfactants
Tolerant to 6% Triton X-100	Tolerant to 0.4% Sodium deoxycholate
Others
Tolerant to 1% EDTA	Tolerant to 5 mM PMSF

 Conclusion: Testing demonstrates no significant differences compared to Competitor M, confirming its reliability as a direct replacement.

 

Residual UltraNuclease Detection

During standard purification processes, UltraNuclease is easily removed as an impurity. To precisely quantify its residual presence, YEASEN Bio offers the UCF.ME™ UltraNuclease ELISA Kit, which utilizes a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA). This kit provides accurate detection of UltraNuclease residues in samples, with excellent linearity, repeatability, recovery rates, and specificity.

 Key Features

• Regulatory Compliance: Fully validated with comprehensive reports available.
• Quality Assurance: All kit components are developed in-house for stringent quality control.
• High Sensitivity: Detection limit as low as 23.5 pg/mL.
• High Precision: Consistent intra- and inter-batch results.
• Strong Specificity: No cross-reactivity with other cellular proteins.

Product parameters	content
Assay time	3.5 hours
Assay principle	Two-site immunoenzymetric assay
Signal amplification	Biotin-streptavidin system
Detection wavelength	450 nm and 630 nm
Sensitivity	23.5 pg/mL
Detection range	0.047~3 ng/mL
Detection object	UltraNuclease
Applicable instrument	Molecular Devices: M and i Series
Application	Detection of residual UltraNuclease in cell and gene therapy (CGT) and recombinant vaccine purification processes

Product Parameters

Standard Curve

 

The kit exhibits excellent linearity (R² = 0.999) across a standard curve range of 0.047–3 ng/mL.

Precision

Repeatability: CV% <5% for six replicates at each concentration.

Concentration ng/mL	6 duplicated date in the same plate						CV value
3	2.412	2.390	2.323	2.367	2.476	2.291	2.53%
1.5	1.780	1.883	1.884	1.908	1.876	1.883	2.19%
0.75	1.123	1.215	1.166	1.183	1.140	1.109	3.12%
0.375	0.691	0.706	0.708	0.722	0.722	0.679	2.21%
0.1875	0.449	0.462	0.453	0.460	0.447	0.433	2.13%
0.094	0.306	0.308	0.304	0.311	0.295	0.302	1.65%
0.047	0.242	0.241	0.240	0.241	0.256	0.240	2.37%
0	0.183	0.192	0.189	0.187	0.189	0.189	1.43%

 

Intermediate Precision: CV% <15% across three analysts.

Sample concentration	1.5 ng/mL	0.375 ng/mL	0.094 ng/mL
Analyst 1	1.388	0.382	0.079
Analyst 2	1.458	0.363	0.068
Analyst 3	1.318	0.37	0.063
Average	1.388	0.372	0.07
SD	0.070	0.010	0.008
CV value	5.04%	2.59%	11.69%

 Production Quality System

Product Information

Product Name	Product number	Product Specifications
UCF.METM UltraNuclease GMP-grade (Benzonase)	20157ES25/50/60/80/90	25KU/50KU/100KU/1MU/5MU
UCF.METM UltraNuclease ELISA Kit	36701ES59	96T

Other Related Products

Product Name	Product number	Product Specifications
UCF.METM Salt Active UltraNuclease GMP-grade	20159ES25/50/60/80/90	25KU/50KU/100KU/1MU/5MU
UCF.METM Salt Active UltraNuclease ELISA kit	36703ES96	96T