Ultra Nuclease

Product Introduction

Ultra Nuclease is an endonuclease, which can degrade all forms of DNA and RNA, hydrolyze the phosphodiester bond of nucleotide like other endonuclease, and completely digest all free nucleotides. The protein consists of two subunits of a molecular weight of about 30kDa, with an isoelectric point of 6. 85.

UltraNuclease is a genetically engineered endonuclaese derived from Serratia marcescens, which is capable of degrade DNA or RNA, either double or single stranded, linear or circular under a wide range of condition, completely degrade nucleic acids into 5’-monophosphate oligonucleotides with 3-5 base length.

After genetic engineering modification, the product was fermented, expressed, and purified in Escherichia coli (E. coli), which reduces the viscosity of cell supernatant and cell lysate in scientific research, but also improve the purification efficiency and functional research of protein. It can also be used in the gene therapy, virus purification, vaccine production, protein and polysaccharide pharmaceutical industry as a host residue nucleic acid removal reagent.

Applications

An efficient and cost-effective removal of nucleic acids is crucial in biomanufacturing processes, such as:

• Purification of Biological Products: Process Purification of Viral Vaccines, Vaccine Virus Vectors, Cell and Gene Therapy.

• Particle pretreatment: remove the nucleic acid wound on the surface of the virus particle, which is conducive to the release and purification of the virus.

• Reduce viscosity: remove the nucleic acid in the crude extract, reduce the viscosity of the solution, and increase the self-production of protein.

• Reduce clumping of stored peripheral blood monocytic cells (PBMC).

Compliance

The enzyme is produced under GMP conditions acc. to GMP regulations without the use of antibiotics and materials with TSE/BSE risk and raw materials from animal origin.

Key Feature

• High enzyme activity, enzyme specific activity ≥ 1. 00 x 10^6 U/mg.

• Good thermal and freeze-thaw stability.

• Stable quality, inter-batch CV < 5%.

• The product has obtained DMF record.

• Animal origin free.

Property	Specification
Product Name	Ultra Nuclease/Super Ultra Nuclease
Molecular Weight	SDS-PAGE
Isoelectric Point	6. 85
Protein Purity	≥ 99% (SDS-PAGE & SEC-HPLC)
Storage Method and Validity Period	-25°C~ -15°C; retains > 90% of its activity in 2 years
Definition of Activity	One unit of Ultra Nuclease is defined as the amount of enzyme that causes a change in absorbance at 260 nm of 1. 0 absorption units within 30 minutes. One unit of Ultra Nuclease also corresponds approximately to the amount of enzyme required to completely digest 37 µg of DNA in 30 minutes under standard assay conditions.

Quality Data

Item	Specification	Method
Appearance	Clear and transparent liquid	Observation with naked-eyes
Dissolubility	Conformity	Pharmacopoeia of the People's Republic of China Volume 4 (2020 Edition) - The First Method: General Rules for Lamp Test (0904)
pH	8. 0 ± 0. 25	Pharmacopoeia of the People's Republic of China Volume 4 (2020 Edition) - General Rules for pH Value Determination Method (0631)
Activity	≥250U/uL (Ultra Nuclease) ≥625U/uL (Super Ultra Nuclease)	Salmon sperm DNA degradation method
Protein Purity	≥99%	Pharmacopoeia of the People's Republic of China (2020 Edition)—General Rules for Electrophoresis Method (0541) Pharmacopoeia of the People's Republic of China (2020 Edition)—General Rules for SEC-HPLC Method (0514)
Proteases	No protease activity	No activity detected after 250KU/ml of enzyme reacting with substrate for 60 min
Bacterial Endotoxin	≤ 0. 25EU/KU	Endotoxin detection kit
Residual Host-cell Protein	≤ 10ppm	ELISA kit
Bioburden	< 10 CFU/100, 000U	Pharmacopoeia of the People's Republic of China Volume 4 (2020 Edition)—General Rules for Sterility Test (1101), PRC National Standard, GB 4789. 2-2016.
Pathogen (HCV/HBV/HIV)	Negative	Pharmacopoeia of the People's Republic of China Volume 4 (2020 Edition)—General Rules for PCR Method (3306)
Mycoplasma	Negative	Mycoplasma detection kit
Heavy Metal	≤ 10ppm	Inductively coupled plasma atomic emission spectrometry, HJ776-2015

Performance Data

Compared under the same enzyme activity.

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

Viscosity reduction in bacterial suspension

Left: bacterial suspension not treated with Ultra Nuclease.

Right: bacterial suspension treated with Ultra Nuclease.

Transportation and Storage

≤0°C transportation, -25~-15°C Storage, 2 years validity (avoid freezing-thawing).

Unit Definition

The amount of enzyme used to change the absorption value of △A260 by 1. 0 within 30min at 37 °C, pH 8. 0, equivalent to digested 37μg salmon sperm DNA by cutting into oligonucleotides, was defined as an active unit (U).