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GENIUS™ Nuclease, premium grade

GMP version GMP-NUES19 is now available for seamless transition.

优势特色(Features)

GENIUS™ Nuclease, premium grade is designed for preclinical stage, has more comprehensive QC testing (such as HCP and so on) and tighter specifications based on the following GENIUS features.

GENIUS™ Nuclease, premium grade has the same activity and performance with GMP Grade Nuclease, which enables a seamless transition from preclinical development to clinical phases. By using GENIUS™ Nuclease, premium grade in your development phase you can easily transit into clinical and commercial phases and avoid needing to amend your manufacturing process and undertake comparability studies.


  • Generally usable: Generally usable for removing all forms of DNA and RNA from biological products, reducing viscosity and preventing cell clumping.
  • Efficient: Efficient reaction, rapid degradation, reduce processing time.
  • Native: Native structure, tag free, the enzyme activity is more guaranteed.
  • Ideal: Ideal for DNA and RNA clearance
  • Ultra pure: Ultra pure: High purity and activit
  • Specific: Specific nuclease, no protease activity

来源(Source)

GENIUS™ Nuclease, premium grade is a tag free recombinant form of Serratia marcescens extracellular endonuclease produced in Escherichia coli cells using a proprietary process at ACRObiosystems. GENIUS™ Nuclease, premium grade is a homodimer with monomer molecular masses about 30 kDa. The enzyme is a non-specific nuclease with high specific activity, which degrades both single- and double-stranded nucleic acids in any form (single stranded, double stranded, linear, circular and supercoiled). It hydrolyzes internal phosphodiester bonds present between the nucleotides to 5’- phosphorylated oligonucleotides of 3-5 bases in length.

反应条件(Operating conditions)

GENIUS™ Nuclease, premium grade is functional between pH 6 and 10 (optimal at pH8 - 8.5) , and from 0°C to 42 °C (optimal at 35 °C - 42 °C). Mg2+ (1-2 mM) is required for enzyme activity.1 mM EDTA reduced the activity by 30% in the presence of 1 mM MgCl2; 0.1 M EDTA eliminated all enzyme activity. In the presence of 1 mM MgCl2, enzyme levels were reduced 75% by 0.1 M CaCl2 or 1 M NaCl. Under standard assay conditions, 1 mM iodoacetate had no effect on the enzymatic rate, whereas 1 mM mercaptoethanol and maleic acid reduced the activity by only 5 to 10%. 10 mM p- Chloromercurybenzoate completely inactivates the enzyme, while 0.64 M beta-mercaptoethanol in the presence of 2 M urea causes only partial inactivation of the enzyme. 4 or 7 M Urea increases the enzyme activity.

应用(Application)

Elimination of nucleic acids from biologics

  1. Preclinical viral vaccine production, which will transit from preclinical development to clinical phases.
  2. Preclinical viral vector production for cell and gene therapy(CGT),which will transit from preclinical development to clinical phases.
  3. Other preclinical development and production uses

酶活(Enzyme Activity)

≥250 U/μL

内毒素(Endotoxin)

Less than 0.01 EU per μg by the LAL method.

宿主蛋白残留(Host Cell Protein)

<0.05ng/ug of protein tested by ELISA.

蛋白酶活性(Protease activity)

negative

无菌(Sterility)

The sterility testing was performed by membrane filtration method.

支原体(Mycoplasma)

Negative

纯度(Purity)

>95% as determined by SDS-PAGE.

>99% as determined by SEC-HPLC.

制剂(Formulation)

Supplied as 0.2 μm filtered solution in 20 mM Tris, 20 mM NaCl, 2 mM MgCl2, pH8.0 with glycerol as protectant.

Contact us for customized product form or formulation.

运输(Shipping)

This product is supplied and shipped with dry ice, please inquire the shipping cost.

存储(Storage)

Avoid repeated freeze-thaw cycles.

This product is stable after storage at:

  1. The product MUST be stored at -20°C or lower upon receipt;
  2. -20°C for 24 months under sterile conditions.
 

电泳(SDS-PAGE)

SDS-PAGE gel

GENIUS™ Nuclease, premium grade on SDS-PAGE under condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.

SEC-HPLC

MALS images

The purity of GENIUS™ Nuclease, premium grade (Cat.No.NUE-S5119) was greater than 99% as determined by SEC-HPLC.

活性(Bioactivity)



Specific activity for GENIUS™ Nuclease, premium grade is measured under standard assay conditions. The specific activity of GENIUS™ Nuclease, premium grade is > 1.2 x 10^6 units/mg protein. One unit will digest sonicated salmon sperm DNA to acid-soluble oligonucleotides equivalent to a ΔA260 of 1.0 in 30 min at pH 8.0 at 37 °C, which corresponds approximately to complete digestion of 37 μg DNA. Note that 1 KU=1000 units.

GENIUS™ Nuclease, premium grade shows high specific activity.

稳定性(Stability)


The specific activity shows that GENIUS™ Nuclease, premium grade is stable at 4°C for 14 days.


The specific activity shows that GENIUS™ Nuclease, premium grade is stable at 37°C for 48 hours.

批间一致性(Batch consistency )

 

背景(Background)

NA

 

 

前沿进展

 
 
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